[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"related-blogs":3,"device-data-324":181,"category-devices-整形用品":3515},[4,34,49,67,86,106,127,147,165],{"id":5,"createdAt":6,"updatedAt":7,"publishedAt":6,"revisedAt":7,"title":8,"content":9,"eyecatch":10,"description":14,"reviewer":15,"category":28},"about-qms","2024-05-20T13:39:12.646Z","2026-03-30T15:08:34.953Z","医療機器QMSとは？QMS省令・ISO13485・QMS適合性調査をわかりやすく解説","\u003Cp>一般的なQMSの意味を知りたい方は、まず「\u003Ca href=\"https://yakuji-navi.com/blogs/about-general-qms\" target=\"_blank\" rel=\"noopener noreferrer\">QMSとは\u003C/a>」の総合解説ページをご覧ください。\u003Cbr>本記事では医療機器分野に限定して、QMS省令・ISO13485・QMS適合性調査の実務を整理します。\u003C/p>\u003Ch2 id=\"hc89f5e8155\">\u003Cstrong>医療機器QMSの概要と重要性\u003C/strong>\u003C/h2>\u003Cp>QMS（品質マネジメントシステム）とは、\u003Cstrong>製品の品質を保証し、安全かつ有効な医療機器を市場に提供するための枠組み\u003C/strong>です。\u003C/p>\u003Cp>医療機器の品質は患者の生命や健康に直結するため、その管理体制には高い信頼性が求められます。医療機器分野では特に厳格な規制のもとで運用されています。\u003C/p>\u003Cp>医療機器QMSは単なる製品検査の体制ではなく、設計開発から製造、出荷後の市販後監視に至るまでの一連のプロセスを管理する包括的なシステムです。医療機器の製造販売業者等は、このQMSを適切に構築・維持することで、\u003Cstrong>安全で有効な医療機器を継続的に提供\u003C/strong>する責任を果たします。\u003C/p>\u003Ch3 id=\"h07382d2a28\">\u003Cstrong>医療機器QMSの特殊性\u003C/strong>\u003C/h3>\u003Cp>医療機器のQMSが他の産業と異なる主な特徴として、以下が挙げられます：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>リスクアプローチ\u003C/strong>：医療機器の使用に伴うリスクの大きさに応じた管理\u003C/li>\u003Cli>\u003Cstrong>規制要件への適合\u003C/strong>：製品を販売する各国の厳格な法規制への対応が必須\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの確保\u003C/strong>：原材料から最終製品、市販後までの追跡可能性\u003C/li>\u003Cli>\u003Cstrong>厳格な変更管理\u003C/strong>：設計・製造工程の変更に対する厳密な管理と検証\u003C/li>\u003Cli>\u003Cstrong>市販後の監視体制\u003C/strong>：出荷後の製品性能や安全性の継続的モニタリング\u003C/li>\u003C/ul>\u003Cp>適切なQMS構築は単なる規制対応ではなく、\u003Cstrong>製品品質の向上や業務効率化\u003C/strong>、そして何より\u003Cstrong>患者安全の確保\u003C/strong>につながる重要な投資と考えるべきです。\u003C/p>\u003Cp>また医療機器のQMSは\u003Cstrong>規制要件\u003C/strong>であることに注意が必要です。様々な業態で採用されているISO 9001のQMSは顧客満足度の向上を図るために継続的改善を行うことを求めていますが、医療機器のQMSは顧客要求事項の達成が継続的に有効であることを求めています。\u003C/p>\u003Cp>つまり、\u003Cstrong>顧客要求事項に含まれていない顧客満足度の向上を図るための改善は求められておらず、それは企業判断で決定してよいことになります\u003C/strong>。 \u003C/p>\u003Ch2 id=\"hf35a4bdbf4\">\u003Cstrong>医療機器QMSの法的要件と規制背景\u003C/strong>\u003C/h2>\u003Ch3 id=\"h5325940781\">\u003Cstrong>国内法規制の枠組み\u003C/strong>\u003C/h3>\u003Cp>日本における医療機器QMSの法的要件は、「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律」（医薬品医療機器等法、通称：薬機法）に基づいています。薬機法第23条の2の5第2項第4号では、医療機器の製造販売承認の要件として、「医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令」（QMS省令：厚生労働省令第169号）への適合が求められています。\u003C/p>\u003Cp>QMSに関する法体系は、上から順に以下のように構成されています：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>法令\u003C/strong>：医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（薬機法）\u003C/li>\u003Cli>\u003Cstrong>政令\u003C/strong>：医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行令\u003C/li>\u003Cli>\u003Cstrong>省令\u003C/strong>：医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令（QMS省令）\u003C/li>\u003Cli>\u003Cstrong>告示\u003C/strong>：各種基準を定める告示\u003C/li>\u003Cli>\u003Cstrong>通達・通知\u003C/strong>：法令の解釈や運用に関する具体的内容（薬食発、薬生発など）\u003C/li>\u003Cli>\u003Cstrong>事務連絡\u003C/strong>：通知の補足や訂正等（法的拘束力はないが実質的影響力がある）\u003C/li>\u003Cli>\u003Cstrong>PMDA通達\u003C/strong>：医療機器のQMS適合性調査に関する通達\u003C/li>\u003C/ul>\u003Cfigure>\u003Cimg src=\"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/2b736b31641c41f8a4ab73f6596a9af9/%E3%83%92%E3%82%9A%E3%83%A9%E3%83%9F%E3%83%83%E3%83%88%E3%82%99%20(2)-min.webp\" alt=\"\" width=\"3144\" height=\"2195\">\u003C/figure>\u003Cp>通達・通知、事務連絡、PMDA通達は頻繁に発出されるため、QMSの担当者は常に最新の情報を入手することも重要です。また、法的拘束力がないことを理由で無視することは適合性調査での指摘につながります。適用しなくてよい説明が求められるため、その根拠を明示できるようにしておきましょう。\u003C/p>\u003Ch3 id=\"h2121268d49\">\u003Cstrong>ISO 13485とQMS省令の関係\u003C/strong>\u003C/h3>\u003Cp>国際規格であるISO 13485（日本ではJIS Q 13485として発行）は、医療機器の品質マネジメントシステム要求事項を規定した規格です。現行のISO 13485:2016（JIS Q 13485:2018）は、医療機器のライフサイクル全体にわたる品質管理を対象としています。\u003C/p>\u003Cp>QMS省令とISO 13485の関係については、以下のポイントが重要です：\u003C/p>\u003Col>\u003Cli>QMS省令はISO 13485に基づいており、基本的な要求事項は共通している\u003C/li>\u003Cli>日本特有の要求事項（例：国内品質業務運営責任者の設置）が一部含まれる\u003C/li>\u003Cli>表現や用語に若干の違いがあるものの、実質的な運用では大きな差異はない\u003C/li>\u003Cli>QMS省令への適合は医療機器製造販売業者及び製造業者に求められるが、ISO13485は医療機器販売・貸与業、修理業も適用範囲に含まれる\u003C/li>\u003C/ol>\u003Cp>多くの製造販売業者は、ISO 13485に基づくQMS構築を行い、そこにQMS省令特有の要求事項を組み込むアプローチを採用しています。\u003C/p>\u003Ch2 id=\"h62523b344a\">\u003Cstrong>医療機器QMSの基本要素とシステム構築\u003C/strong>\u003C/h2>\u003Ch3 id=\"hdf19452817\">\u003Cstrong>QMSの主要要素\u003C/strong>\u003C/h3>\u003Cp>医療機器QMSは、以下の主要要素で構成されます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>管理監督者の責任\u003C/strong>：品質方針・目標の設定、組織体制の構築、マネジメントレビュー\u003C/li>\u003Cli>\u003Cstrong>資源の管理監督\u003C/strong>：人的資源、インフラストラクチャ、作業環境の管理\u003C/li>\u003Cli>\u003Cstrong>製品実現\u003C/strong>：設計開発管理、購買管理、製造工程の管理、バリデーション\u003C/li>\u003Cli>\u003Cstrong>測定・分析・改善\u003C/strong>：工程および製品の監視測定、不適合製品の管理、データ分析、是正・予防処置\u003C/li>\u003Cli>\u003Cstrong>文書化要件\u003C/strong>：品質マニュアル、手順書、記録、製品標準書\u003C/li>\u003C/ol>\u003Ch3 id=\"hc573519de2\">\u003Cstrong>QMS構築のステップバイステップガイド\u003C/strong>\u003C/h3>\u003Cp>医療機器QMSを構築するための一般的なステップは以下の通りです：\u003C/p>\u003Cp>\u003Cstrong>ステップ1：品質方針の策定\u003C/strong>\u003C/p>\u003Cp>企業の経営陣は、組織の目的と方向性に合致した品質方針を策定し、全従業員に周知徹底します。品質方針を達成するための具体的な中長期目標が品質目標となります。\u003C/p>\u003Cp>\u003Cstrong>ステップ2：組織の構築\u003C/strong>\u003C/p>\u003Cp>QMSを効果的に運用するための組織体制を構築します：\u003C/p>\u003Cul>\u003Cli>管理責任者の任命：QMS全体を統括する責任者\u003C/li>\u003Cli>品質保証部門の設置：QMSの運用を担当する部門、専任部門でなくてもよい\u003C/li>\u003Cli>各部門の役割と責任の明確化：製造販売三役（総括製造販売責任者、国内品質業務運営責任者、安全管理責任者）など\u003C/li>\u003Cli>クロスファンクショナルチームの編成：部門横断的なQMS活動推進\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>ステップ3：プロセスの定義と文書化\u003C/strong>\u003C/p>\u003Cp>QMSに必要なプロセスを定義し、文書化します：\u003C/p>\u003Cul>\u003Cli>設計・開発管理プロセス\u003C/li>\u003Cli>製造プロセス管理\u003C/li>\u003Cli>供給者管理プロセス\u003C/li>\u003Cli>製品管理プロセス\u003C/li>\u003Cli>リスクマネジメントプロセス\u003C/li>\u003Cli>内部監査プロセス\u003C/li>\u003Cli>是正・予防措置（CAPA）プロセス\u003C/li>\u003Cli>文書・記録管理プロセス\u003C/li>\u003Cli>教育訓練プロセス\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>ステップ4：教育と訓練\u003C/strong>\u003C/p>\u003Cp>QMSの効果的な運用には全従業員の理解と協力が不可欠です：\u003C/p>\u003Cul>\u003Cli>QMSの基本概念と重要性に関する全社教育\u003C/li>\u003Cli>QMS業務運用に必要な力量（知識、経験、資格等）の明確化\u003C/li>\u003Cli>各部門・職位の力量の程度に応じた専門的なQMS教育\u003C/li>\u003Cli>担当業務の定期的な理解度確認とリフレッシュ研修\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>ステップ5：QMSの導入と評価\u003C/strong>\u003C/p>\u003Cp>定義されたプロセスを実際に運用し、その効果を定期的に評価します：\u003C/p>\u003Cul>\u003Cli>パイロット導入：特定の部門や製品ラインでの試験的導入\u003C/li>\u003Cli>全社展開：パイロット結果を踏まえた全社的展開\u003C/li>\u003Cli>モニタリングと測定：定義された品質指標によるQMS効果測定\u003C/li>\u003Cli>内部監査の実施：QMSの適合性と有効性の確認\u003C/li>\u003Cli>マネジメントレビュー：経営陣によるQMS評価と改善方針の決定\u003C/li>\u003Cli>改善の実施：有効性維持のための改善活動\u003C/li>\u003C/ul>\u003Ch2 id=\"hfabf8dde87\">\u003Cstrong>QMS省令対応のための実践的アプローチ\u003C/strong>\u003C/h2>\u003Cp>QMS省令に効果的に対応するためには、リスクベースアプローチと製品実現プロセスの適切な設計、そして効果的な不適合管理が不可欠です。中でも製品実現プロセスはQMS省令の第5節（第26条〜第53条）で広範囲に規定されており、医療機器の品質と安全性を直接左右する中心的要素であるため、以下に詳細に解説します。\u003C/p>\u003Ch3 id=\"hfc24d32c39\">\u003Cstrong>リスクアプローチの適用\u003C/strong>\u003C/h3>\u003Cp>医療機器QMSの中核となる考え方は「リスクアプローチ」です。QMS省令第5条の2第2号では、「製品に係る医療機器等の機能、性能及び安全性に係るリスク並びに当該リスクに応じた管理の程度」を明確にすることが求められています。基本的には、定義したプロセスから逸脱があった場合の医療機器等の機能、性能及び安全性への影響をもとに管理水準を定めます。\u003C/p>\u003Cp>実践的なリスクアプローチの適用方法として：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>製品リスク分類に基づく管理レベルの設定\u003C/strong>\u003Cul>\u003Cli>クラスⅠ〜Ⅳの医療機器分類に応じた管理レベルの差別化\u003C/li>\u003Cli>高リスク製品に対するより厳格な検証・バリデーション\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>プロセスリスク評価\u003C/strong>\u003Cul>\u003Cli>各製造工程の製品品質への影響度評価\u003C/li>\u003Cli>重要工程の特定と重点的管理\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>変更管理におけるリスク評価\u003C/strong>\u003Cul>\u003Cli>設計・製造変更の影響度評価\u003C/li>\u003Cli>リスクに応じた検証範囲の決定\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>供給者管理のリスクベース実施\u003C/strong>\u003Cul>\u003Cli>部材の重要度に応じた供給者評価・管理の深さ調整\u003C/li>\u003Cli>クリティカル部材提供者への重点監査\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h1af5e55ab2\">\u003Cstrong>製品実現プロセスの設計\u003C/strong>\u003C/h3>\u003Cp>製品実現プロセスは、QMS省令第5節（第26条〜第53条）に詳細に規定されています。効果的な製品実現プロセスの構築ポイントは以下の通りです：\u003C/p>\u003Cp>\u003Cstrong>設計開発管理\u003C/strong>\u003C/p>\u003Cul>\u003Cli>設計開発計画の策定（適用する設計開発の段階と設計レビュー計画、検証・バリデーション計画）\u003C/li>\u003Cli>設計インプット（機能・性能要件、法規制要件、リスクマネジメント情報、ユーザビリティ評価結果）\u003C/li>\u003Cli>設計アウトプット（製品仕様、製造指示書・図面、検査基準、取扱説明書等）\u003C/li>\u003Cli>その他、設計レビュー、検証、バリデーション、設計移管、変更管理、設計履歴ファイルなど\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>製造工程管理\u003C/strong>\u003C/p>\u003Cul>\u003Cli>製造工程の計画と文書化\u003C/li>\u003Cli>製造設備の適格性確認（DQ、IQ、OQ、PQ）\u003C/li>\u003Cli>工程パラメータの監視\u003C/li>\u003Cli>製造バリデーション\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>不適合管理とCAPAシステム\u003C/strong>\u003C/p>\u003Cp>QMS省令第60条〜第64条に規定されている不適合管理と是正・予防措置（CAPA）は、問題の再発防止と継続的改善の要となるプロセスです。\u003C/p>\u003Cp>効果的なCAPAシステムのポイント：\u003C/p>\u003Cul>\u003Cli>必要十分な不適合の影響範囲の特定と原因調査\u003C/li>\u003Cli>適切な根本原因分析ツールの使用\u003C/li>\u003Cli>CAPAの優先順位づけと期限管理\u003C/li>\u003Cli>組織横断的なCAPAレビュー\u003C/li>\u003Cli>CAPAの水平展開\u003C/li>\u003C/ul>\u003Ch2 id=\"h66174d229f\">\u003Cstrong>成功事例と失敗事例に学ぶQMSの実践\u003C/strong>\u003C/h2>\u003Cp>QMSの導入と運用において、他社の経験から学ぶことは非常に有益です。ここでは、実際の成功事例と失敗事例を比較し、その要因を分析します。\u003C/p>\u003Ch3 id=\"h78dc91797c\">\u003Cstrong>医療機器業界における成功事例\u003C/strong>\u003C/h3>\u003Cp>中堅の血糖測定器メーカー（従業員約300名、年間売上80億円）は、体系的なQMS導入によって大きな成果を挙げました。彼らの成功の核心は、全社的な取り組みとデータに基づく意思決定にありました。\u003C/p>\u003Cp>同社は次のようなアプローチでQMSを導入しました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>トップマネジメントの強いコミットメント\u003C/strong> - 経営層が率先してQMSの重要性を訴え、必要なリソースを確保しました。\u003C/li>\u003Cli>\u003Cstrong>リスクアプローチの徹底導入\u003C/strong> - 製品とプロセスのリスクを体系的に評価し、重要度に応じた管理を実施しました。\u003C/li>\u003Cli>\u003Cstrong>プロセスアプローチの採用と責任者の明確化\u003C/strong> - 各プロセスの相互関係を明確にし、責任者を任命することで説明責任を強化しました。\u003C/li>\u003Cli>\u003Cstrong>データ駆動型の意思決定\u003C/strong> - 客観的なデータに基づいて意思決定を行い、感覚的な判断を排除しました。\u003C/li>\u003C/ol>\u003Cp>さらに、サプライヤー管理の強化、体系的な教育訓練、効果的なCAPAシステムの運用、そして文書管理システムの刷新も実施しました。\u003C/p>\u003Cp>これらの取り組みの結果、QMS維持管理が効率的になり\u003Cstrong>リソースが20％削減\u003C/strong>、製品品質が向上し\u003Cstrong>不良品率が前年比40%減少\u003C/strong>しました。また、\u003Cstrong>顧客クレームは30%減少し、製造リードタイムが20%短縮\u003C/strong>されるなど、業務効率も大幅に改善しました。さらにQMS適合性調査でゼロ指摘を達成したことで、欧州と東南アジア市場への展開が加速し、\u003Cstrong>海外売上が倍増する\u003C/strong>という成果を上げています。\u003C/p>\u003Ch3 id=\"h6f8845176c\">\u003Cstrong>医療機器業界における失敗事例\u003C/strong>\u003C/h3>\u003Cp>一方、ある新興のウェアラブル心拍モニターメーカー（従業員約100名）は、QMS導入に失敗し、深刻な結果を招きました。彼らの失敗は、QMSを単なる形式的な手続きと捉え、品質管理の本質を理解していなかったことに起因します。\u003C/p>\u003Cp>主な失敗要因は以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>トップマネジメントの無関心\u003C/strong> - 経営層がQMSを「規制対応のための必要悪」と考え、積極的な関与がありませんでした。\u003C/li>\u003Cli>\u003Cstrong>リスク管理の不足\u003C/strong> - 製品リスクの体系的な評価が行われず、潜在的な問題が見過ごされました。\u003C/li>\u003Cli>\u003Cstrong>プロセスの標準化不足\u003C/strong> - 個々のプロセスは定義されていましたが、前後の関連プロセスとの連携が考慮されていませんでした。\u003C/li>\u003C/ol>\u003Cp>データ管理の不備、サプライヤー管理の甘さ、従業員教育の不足、関係者への情報共有不足なども重大な問題でした。特に変更管理の不備と文書管理の混乱は、製品の一貫性を損なう直接的な原因となりました。\u003C/p>\u003Cp>これらの問題により、心拍数の誤測定が発生し、\u003Cstrong>数千台のリコールを余儀なくされました\u003C/strong>。さらにPMDAから適合証明書が発行されず生産停止を命じられるという事態に発展。\u003Cstrong>リコールと生産停止により年間売上が40%減少\u003C/strong>し、メディアでの報道により企業イメージも大きく損なわれる結果となりました。\u003C/p>\u003Ch2 id=\"hfbc51bc09b\">\u003Cstrong>QMS効果的運用のための課題と対応\u003C/strong>\u003C/h2>\u003Cp>QMSを構築しただけでは不十分です。その効果を継続的に維持・向上させるためには、適切なモニタリングと評価（監視測定）、そして日常的に直面する課題への対応が必要です。\u003C/p>\u003Cp>一般的に、不適合が発生した後の是正措置は、あらかじめ検討した手順の構築と運用に比べ、3倍以上のリソースと時間を要するといわれています。\u003C/p>\u003Ch3 id=\"hb9e8ff209f\">\u003Cstrong>モニタリングと評価方法\u003C/strong>\u003C/h3>\u003Cp>効果的なQMSの運用には、システムのパフォーマンスを定期的に測定し評価することが欠かせません。以下の4つの視点からモニタリングを行うことで、QMSの健全性を総合的に評価できます。\u003C/p>\u003Col>\u003Cli>\u003Cstrong>パフォーマンス指標（KPI）の設定と追跡\u003C/strong> 定量的な指標を設定することで、QMSの効果を客観的に評価できます。製品品質指標（不良品率、顧客クレーム数など）だけでなく、プロセス性能指標（製造サイクルタイム、歩留まりなど）やシステム有効性指標（内部監査での指摘事項数、CAPAの有効性など）も重要です。これらの指標を定期的に測定し、トレンドを分析することで改善の機会を特定できます。\u003C/li>\u003Cli>\u003Cstrong>内部監査プログラム\u003C/strong> 計画的な内部監査は、QMSの客観的な評価手段として極めて有効です。特にプロセスベースの監査アプローチを採用し、プロセスの相互関係や有効性に焦点を当てることで、形式的なチェックにとどまらない実質的な改善につながります。監査結果は体系的に分析し、組織的な改善の機会として活用することが重要です。\u003C/li>\u003Cli>\u003Cstrong>マネジメントレビュー\u003C/strong> 経営層による定期的なQMS評価は、システム全体の方向性を確認する重要な機会です。ここでは、QMSの有効性を包括的に評価し、必要な改善のための資源配分を決定します。単なる報告会ではなく、戦略的な意思決定の場として活用することがポイントです。\u003C/li>\u003Cli>\u003Cstrong>その他の評価方法\u003C/strong> 顧客要求達成度の分析、プロセス分析と最適化、リスク評価の定期的な見直しなども重要な評価手段です。また、サプライヤー評価、教育訓練効果の評価、CAPA有効性の評価など、多角的な視点からQMSを評価することで、盲点を減らし総合的な改善につなげることができます。\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">\u003Cstrong>よくある課題とその対応方法\u003C/strong>\u003C/h3>\u003Cp>QMSの運用には多くの企業が共通して直面する課題があります。以下に主な課題とその対応方法を示します。\u003C/p>\u003Col>\u003Cli>\u003Cstrong>文書管理の負担\u003C/strong> QMSにおける文書管理は多くの企業にとって大きな負担となっています。この負担を軽減するためには、電子文書管理システムの導入が効果的です。また、文書体系を最適化し、真に必要な文書に焦点を当てることで、管理の簡素化が可能になります。文書の目的と価値を常に意識し、不必要な複雑さを排除することが重要です。\u003C/li>\u003Cli>\u003Cstrong>形式主義への陥り\u003C/strong> QMSが単なる形式的な手続きに陥らないよう、プロセスアプローチを強化し、品質目標と事業目標の連携を図ることが重要です。CAPAの進捗管理を徹底し、実質的な改善に結びつけることで、「やらされ感」を払拭し、QMSの本来の価値を引き出すことができます。\u003C/li>\u003Cli>\u003Cstrong>リソースの制約\u003C/strong> 限られたリソースでQMSを効果的に運用するには、リスクアプローチによるリソースの最適配分が不可欠です。また、自動化ツールの導入による効率化も検討すべきでしょう。重要度と緊急度のマトリックスを用いて優先順位付けを行い、限られたリソースを最大限に活用する戦略が求められます。\u003C/li>\u003C/ol>\u003Cp>その他、従業員の理解と関与の不足、変更管理の困難さ、サプライヤー管理の複雑さ、不適合の再発などの課題に対しても、体系的かつ具体的な対応策を講じることが、QMSの効果的な運用には欠かせません。\u003C/p>\u003Ch2 id=\"hcae34679e3\">\u003Cstrong>ISO 13485認証取得のためのステップ\u003C/strong>\u003C/h2>\u003Cp>グローバル市場での競争力強化や信頼性向上のために、ISO 13485認証取得は重要な戦略となります。認証取得は一朝一夕にできるものではなく、計画的なアプローチが必要です。\u003C/p>\u003Ch3 id=\"h8e9155c230\">\u003Cstrong>認証取得の準備と計画立案\u003C/strong>\u003C/h3>\u003Cp>認証取得の成功は、入念な準備と計画にかかっています。まず、認証取得の目的を明確化することから始めましょう。単なる「認証書」の獲得が目的ではなく、QMSの実質的な改善や市場競争力の強化など、組織にとっての真の価値を定義することが重要です。\u003C/p>\u003Cp>次に、経営層のコミットメントを確保します。認証取得には相応のリソースと組織的な取り組みが必要であり、経営層の理解と支援なしには成功しません。\u003C/p>\u003Cp>計画立案では以下のステップを踏みます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>プロジェクトチームの編成\u003C/strong> - 各部門の代表者を含む横断的なチームを構成\u003C/li>\u003Cli>\u003Cstrong>認証機関の選定\u003C/strong> - 業界経験や評判を考慮して適切な認証機関を選ぶ\u003C/li>\u003Cli>\u003Cstrong>スケジュールと必要リソースの計画\u003C/strong> - 現実的な取得スケジュールと必要リソースの特定\u003C/li>\u003C/ol>\u003Ch3 id=\"h11035eb2d0\">\u003Cstrong>ギャップ分析の実施方法\u003C/strong>\u003C/h3>\u003Cp>現状のQMSとISO 13485要求事項とのギャップを明確にすることは、効率的な認証取得の基盤となります。このプロセスは、単なるチェックリストの確認ではなく、体系的な分析が必要です。\u003C/p>\u003Cp>ギャップ分析は次のステップで進めます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>チェックリストの準備\u003C/strong> - ISO 13485の要求事項に基づく詳細なチェックリスト作成\u003C/li>\u003Cli>\u003Cstrong>文書レビュー\u003C/strong> - 既存のQMS文書とISO要求事項の比較分析\u003C/li>\u003Cli>\u003Cstrong>インタビューと現場観察\u003C/strong> - 実際の運用状況の確認と評価\u003C/li>\u003Cli>\u003Cstrong>ギャップ報告書の作成\u003C/strong> - 発見事項の文書化と分析\u003C/li>\u003Cli>\u003Cstrong>優先順位づけと対応計画策定\u003C/strong> - 重要度と取り組みやすさを考慮した改善計画の策定\u003C/li>\u003C/ol>\u003Cp>分析結果はプロジェクトチームで共有し、全体の現状把握に役立てましょう。\u003C/p>\u003Ch3 id=\"hd54caa99ee\">\u003Cstrong>内部監査の実施と是正処置\u003C/strong>\u003C/h3>\u003Cp>内部監査は認証審査の予行演習であると同時に、QMSの有効性を確認する重要なプロセスです。形式的なチェックに終わらせず、実質的な改善につながる内部監査を実施することが重要です。\u003C/p>\u003Cp>効果的な内部監査のためには、まず適切な内部監査員の養成が必要です。外部研修の活用や認証機関によるトレーニングを検討しましょう。次に、全プロセスをカバーする監査計画を策定し、具体的なチェックリストを準備します。\u003C/p>\u003Cp>監査実施後は、発見された不適合に対する是正処置を迅速に実施し、その有効性を評価することが重要です。この一連のプロセスを通じて、認証審査に向けたQMSの完成度を高めていきます。\u003C/p>\u003Ch3 id=\"hb3825496af\">\u003Cstrong>認証審査プロセスの流れ\u003C/strong>\u003C/h3>\u003Cp>ISO 13485認証取得のための審査プロセスは複数の段階で構成されています。まず申請・契約段階では、認証機関との契約を締結し、審査範囲や日程を決定します。次に文書審査（第一段階審査）で、QMSの基本文書が要求事項を満たしているか確認されます。\u003C/p>\u003Cp>実地審査（第二段階審査）では、実際の現場確認と面談が行われ、QMSが効果的に運用されているかが評価されます。審査で指摘された事項に対しては、適切な是正処置を実施し、認証機関の評価を受けます。\u003C/p>\u003Cp>全ての要求事項が満たされていると判断されれば、認証書が発行されます。認証取得後は、年1回のサーベイランス審査と3年ごとの更新審査により、QMSの継続的な適合性が確認されます。\u003C/p>\u003Ch2 id=\"h1e83562307\">\u003Cstrong>QMS適合性調査とISO認証\u003C/strong>\u003C/h2>\u003Cp>日本の医療機器メーカーにとって、QMS適合性調査は避けて通れない重要なプロセスです。ISO 13485認証とは異なる視点と要求事項があるため、その違いを理解し、適切に対応することが求められます。\u003Cstrong> \u003C/strong>\u003C/p>\u003Ch3 id=\"hcf3e3cb163\">\u003Cstrong>QMS適合性調査とISO認証審査の違い\u003C/strong>\u003C/h3>\u003Cp>適合性調査とISO認証審査は目的や性質が異なります。下表にその主な違いをまとめました。\u003C/p>\u003Ctable>\u003Ctbody>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>\u003Cstrong>項目\u003C/strong>\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>\u003Cstrong>適合性調査\u003C/strong>\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>\u003Cstrong>ISO認証審査\u003C/strong>\u003C/p>\u003C/td>\u003C/tr>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>目的\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>QMS省令への適合性確認\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>ISO 13485規格への適合性確認\u003C/p>\u003C/td>\u003C/tr>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>調査組織\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>PMDAもしくは登録第三者認証機関\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>第三者認証機関\u003C/p>\u003C/td>\u003C/tr>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>法的位置づけ\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>薬機法に基づく法的義務\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>任意の認証制度\u003C/p>\u003C/td>\u003C/tr>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>頻度\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>5年ごと（定期）＋随時\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>年1回＋3年ごと更新\u003C/p>\u003C/td>\u003C/tr>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>対象範囲\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>製品群ごと\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>組織の活動範囲全体\u003C/p>\u003C/td>\u003C/tr>\u003Ctr>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>結果の影響\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>行政処分の可能性\u003C/p>\u003C/td>\u003Ctd colspan=\"1\" rowspan=\"1\">\u003Cp>認証の一時停止・取消の可能性\u003C/p>\u003C/td>\u003C/tr>\u003C/tbody>\u003C/table>\u003Ch3 id=\"hcbc660bcdc\">\u003Cstrong> QMS適合性調査対応のためのチェックリスト\u003C/strong>\u003C/h3>\u003Cp>適合性調査を成功させるためには、調査の各段階で適切な対応を行うことが重要です。以下に調査前、調査中、調査後の重要なチェックポイントを示します。\u003C/p>\u003Cp>\u003Cstrong>調査前の準備\u003C/strong>\u003C/p>\u003Cp>調査前の準備が調査結果を大きく左右します。まず前回調査での指摘事項と是正状況を確認し、同様の問題が再発していないことを確認します。また、主要文書・記録を整理し、スムーズに提示できるよう準備しておきましょう。\u003C/p>\u003Cp>対応チームの編成と役割分担も重要です。各担当者が自分の責任範囲を明確に理解し、必要な知識を身につけておくことで、調査当日の混乱を防ぐことができます。調査対応の模擬練習も効果的です。\u003C/p>\u003Cp>\u003Cstrong>調査中の対応\u003C/strong>\u003C/p>\u003Cp>調査中は、調査官の質問に的確に回答することが重要です。不明点がある場合は推測で回答せず、確認してから回答するようにしましょう。また、指摘事項があった場合は、その内容を正確に理解し、反論すべき点と受け入れるべき点を冷静に判断することが重要です。\u003C/p>\u003Cp>\u003Cstrong>調査後の対応\u003C/strong>\u003C/p>\u003Cp>調査後は、指摘事項に対する是正計画を迅速に立案し実施します。表面的な対応ではなく、根本原因の分析に基づいた実効性のある是正措置を講じることが重要です。また、類似の問題が他の製品や工程で発生していないか確認し、水平展開による予防処置も実施しましょう。\u003C/p>\u003Ch2 id=\"hfe0f7dc6ed\">\u003Cstrong>まとめと今後の展望\u003C/strong>\u003C/h2>\u003Cp>医療機器のQMSは、単なる規制要件への対応ではなく、製品の品質と安全性を確保するための重要な経営基盤です。最後に、QMSの重要ポイントを再確認し、成功のための最終アドバイスを提示します。\u003C/p>\u003Cp>\u003Cstrong>医療機器QMSの重要ポイント再確認\u003C/strong>\u003C/p>\u003Cp>医療機器QMSを成功させるためには、以下の7つのポイントが特に重要です。\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者安全を最優先とする姿勢\u003C/strong> QMSの最終目的は患者安全の確保であることを常に意識することが重要です。製品の品質向上は患者の生命と健康を守るために不可欠であるという認識を、組織全体で共有することが基本です。\u003C/li>\u003Cli>\u003Cstrong>リスクに応じた管理レベルの設定\u003C/strong> 限られたリソースを効果的に活用するため、リスクの大きさに応じて管理レベルを設定することが重要です。すべてを同じレベルで管理するのではなく、影響の大きいプロセスや部品に重点的にリソースを投入する戦略的アプローチが求められます。\u003C/li>\u003Cli>\u003Cstrong>経営層のコミットメントと関与\u003C/strong> QMSの成功には経営層の積極的な関与が不可欠です。形式的な承認だけでなく、経営層自身がQMSの重要性を理解し、必要なリソースを確保するとともに、率先して品質文化を醸成する姿勢が求められます。\u003C/li>\u003Cli>\u003Cstrong>説明責任　\u003C/strong>QMSの要求事項を達成するために、どのようなプロセス、手順、記録を残すかは企業が検討し、定めるものになります。したがって、品質マニュアル以下の文書体系で示された内容の是非説明責任は企業にあります。他社に倣った、是正措置事例集に倣ったというのは理由として適切ではありません。\u003C/li>\u003C/ol>\u003Cp>他にも製品ライフサイクル全体の管理、実証主義（客観的証拠の重視）、継続的な有効性の維持が重要なポイントとなります。これらを総合的に実践することで、強固なQMSの基盤を築くことができます。\u003C/p>\u003Cp>\u003Cstrong>QMS導入・維持での成功のための最終アドバイス\u003C/strong>\u003C/p>\u003Cp>最後に、QMS導入と維持における成功のためのアドバイスを以下にまとめます。\u003C/p>\u003Col>\u003Cli>\u003Cstrong>「完璧を目指すよりも継続的な有効性維持を」\u003C/strong> QMSは一度完成すれば終わりというものではありません。環境変化・要求事項の変化に応じて継続的に改善し、有効性を維持することが重要です。完璧な文書よりも、実効性のあるシステムを目指しましょう。\u003C/li>\u003Cli>\u003Cstrong>「現場の実態に合ったシステム設計を」\u003C/strong> 理想的なシステムが必ずしも現場に適合するとは限りません。現場の実態と能力を考慮し、実行可能で持続可能なシステムを設計することが重要です。現場との対話を通じて、理想と現実のバランスを取りましょう。\u003C/li>\u003Cli>\u003Cstrong>「教育と理解の深化に投資を」\u003C/strong> QMSは人によって運用されるものです。関係者全員がその目的と要件を理解し、自分の役割を認識することが成功の鍵となります。教育訓練は形式的なものではなく、実質的な理解を深めるものであるべきです。\u003C/li>\u003C/ol>\u003Cp>「リソースと期待のバランスを」「規制対応から価値創造へ」「先を見据えた柔軟なシステム設計を」など、その他のアドバイスも考慮しながら、組織に適したQMSを構築・維持することが重要です。\u003C/p>\u003Cp>医療機器のQMS構築と維持は容易ではありませんが、患者の安全と製品の品質を確保するための不可欠な取り組みです。QMSを単なる規制要件の遵守ツールではなく、組織の品質文化を形成し、患者の生活の質を向上させるための戦略的な基盤として位置づけることで、真の価値を生み出すことができるでしょう。\u003C/p>",{"url":11,"height":12,"width":13},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/8d278ef08abd444daac1261029846fea/qms-min.webp",739,1183,"QMSの基本から実装、ISO 13485認証取得まで完全ガイド。患者安全を確保する品質マネジメントシステムの構築法、QMS省令への対応方法、成功・失敗事例を徹底解説。リスクベースアプローチで効率的な品質管理を実現し、国内外の規制に適合しながら製品の安全性と有効性を向上させる実践的手法を学べます。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":20,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},"l0496behlnj1","2024-09-09T08:43:43.850Z","2024-09-26T16:00:16.227Z","居原 範道",{"url":21,"height":22,"width":23},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/f65490240dc1402a94f557918b022042/ihara2-min.webp",247,183,"\u003Cp>信州大学理学部卒業後、バクスター株式会社で製造エンジニアとしてキャリアをスタート。\u003C/p>\u003Cp>その後、アボットジャパン株式会社とボストンサイエンティフィックジャパン株式会社で品質保証責任者を務め、GQP/QMS構築・改善、QMS調査、製品回収に伴う行政対応など、重要な責務を担当。40年以上の医療機器業界経験を持ち、GMP活動、プロセスバリデーション、滅菌サイクル開発にも精通。\u003C/p>\u003Cp>現在はQMサービス.IHARAの代表として、医療機器QMSに関する企業コンサルティング、セミナー講師、著作活動を展開。JRCA/IRCA認定ISO9001審査員の資格を有し、実践的なQMS管理の専門知識で業界に貢献している。\u003C/p>","医療機器QMSコンサルタント","https://sites.google.com/a/qmserve.com/qms-i/home/%E3%83%97%E3%83%AD%E3%83%95%E3%82%A3%E3%83%BC%E3%83%AB","https://koushiru.com/lecturer/n-ihara/",[29],{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},"apxnqwqnf","2024-05-20T13:39:11.460Z","2024-05-31T01:49:21.189Z","QMS基礎",{"id":35,"createdAt":36,"updatedAt":37,"publishedAt":38,"revisedAt":37,"title":39,"content":40,"eyecatch":41,"description":44,"reviewer":45,"category":47},"qms-sop","2024-09-04T02:49:54.273Z","2024-10-22T06:19:28.853Z","2024-09-25T00:42:22.277Z","SOP（標準作業手順書）とは？","\u003Ch2 id=\"h2e57b0d1c5\">SOP（標準作業手順書）とは？\u003C/h2>\u003Cp>SOP（Standard Operating Procedure）は、日本語で「標準作業手順書」と訳され、特定の業務や作業を行う際の標準的な手順を文書化したものです。医療機器業界において、SOPは品質管理システム（QMS）の重要な要素の一つとして位置づけられています。\u003C/p>\u003Cp>SOPに似通ったものとして「実施要領書」があります。これは、SOPに含まれる特定の作業、機器の操作方法などをまとめたもので、「作業手順書」、「ワークインストラクション」、「マニュアル」などと呼ばれることもあります。\u003C/p>\u003Cfigure>\u003Cimg src=\"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/cbc3e202ebec4d969cafb3b9303f507f/SOP.png\" alt=\"文書体系図\" width=\"316\" height=\"264\">\u003C/figure>\u003Ch3 id=\"h286faa8665\">具体的な定義\u003C/h3>\u003Cp>SOPとは、ある特定の業務や作業を行う際に、\u003Cstrong>誰が、いつ、どこで、何を、どのように行うかを詳細に記述した文書\u003C/strong>のことを指します。これは、単なる作業マニュアルではなく、法令遵守や品質管理の観点から重要な役割を果たす品質文書です。\u003C/p>\u003Cp>医療機器業界では、製品の設計、製造、検査、保管、出荷などの各工程において、SOPが作成され、厳密に管理されています。例えば、滅菌処理を行う医療機器の製造ラインでは、「滅菌工程SOP」といった具体的な手順書が存在し、滅菌の方法、時間、温度、確認方法などが詳細に記載されています。\u003C/p>\u003Ch3 id=\"he2485005d0\">目的\u003C/h3>\u003Cp>SOPの主な目的は以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>品質の一貫性確保：\u003C/strong> SOPを通じて標準化された手順を実施することで、製品やサービスの品質を一定に保つことができます。医療機器の場合、患者の安全に直結するため、品質の一貫性は特に重要です。\u003C/li>\u003Cli>\u003Cstrong>エラーの防止： \u003C/strong>明確な手順を文書化することで、作業者の誤りや判断ミスを減らすことができます。例えば、複雑な組立工程を持つ医療機器の製造において、SOPは作業者が正確に手順を追うためのガイドラインとなります。\u003C/li>\u003Cli>\u003Cstrong>法令遵守の徹底：\u003C/strong> 医療機器業界は厳格な規制下にあり、SOPはこれらの規制要件を満たすための重要なツールとなります。例えば、PMDA（独立行政法人 医薬品医療機器総合機構）のQMS調査に備えて、製造プロセスの各段階でSOPを整備することが求められます。\u003C/li>\u003Cli>\u003Cstrong>知識の継承と教育： \u003C/strong>SOPは組織の知識や経験を文書化したものであり、新しい従業員の教育や技術の継承に役立ちます。例えば、ベテラン技術者の退職時に、その専門知識をSOPとして残すことで、組織の技術力を維持することができます。\u003C/li>\u003Cli>\u003Cstrong>継続的改善の基盤：\u003C/strong> SOPは定期的に見直され、改訂されることで、業務プロセスの継続的な改善につながります。例えば、新しい技術や規制の変更に合わせてSOPを更新することで、常に効率的で最適な手順を維持できます。\u003C/li>\u003C/ol>\u003Cp>このように、SOPは医療機器業界において、高品質な製品を安定して提供し、患者の安全を確保するための重要なツールとして機能しています。\u003C/p>\u003Ch2 id=\"hb423ce929e\">SOPの必要性\u003C/h2>\u003Ch3 id=\"h4a784b5a9d\">なぜ必要なのか？\u003C/h3>\u003Cp>医療機器業界においてSOPが必要とされる理由は多岐にわたりますが、主に以下の点が挙げられます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者の安全確保： \u003C/strong>医療機器は人命に直接関わる製品であり、その品質と安全性の確保は最優先事項です。SOPを通じて標準化された手順を実施することで、製品の信頼性を高め、患者の安全を守ることができます。\u003C/li>\u003Cli>\u003Cstrong>規制要件の遵守： \u003C/strong>医療機器業界は、PMDAやFDA（アメリカ食品医薬品局）などの規制当局による厳しい監督下にあります。SOPは、これらの規制要件を満たすための具体的な方法を示す重要な文書となります。\u003C/li>\u003Cli>\u003Cstrong>品質管理システム（QMS）の基盤：\u003C/strong> SOPは、ISO 13485やFDA 21 CFR Part 820などの品質管理システム規格の要求事項を満たすための重要な要素です。これらの規格では、プロセスの文書化と管理が求められており、SOPはその中心的な役割を果たします。\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの確保：\u003C/strong> 医療機器の製造過程や使用状況を追跡できることは、問題発生時の原因究明や改善に不可欠です。SOPを通じて各プロセスを文書化することで、製品のライフサイクル全体にわたる製品の安全性に関するトレーサビリティを確保できます。\u003C/li>\u003Cli>\u003Cstrong>リスク管理： \u003C/strong>医療機器の開発や製造には様々なリスクが伴います。SOPを通じてリスク評価や管理の手順を明確化することで、潜在的な問題を事前に特定し、対策を講じることができます。\u003C/li>\u003C/ol>\u003Ch3 id=\"had4a1e1a63\">対象となる活動や範囲\u003C/h3>\u003Cp>SOPの対象となる活動や範囲は、医療機器のライフサイクル全体にわたります。具体的には以下のような領域が含まれます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>設計開発：\u003C/strong>\u003Cul>\u003Cli>設計開発計画の策定\u003C/li>\u003Cli>設計仕様の作成\u003C/li>\u003Cli>プロトタイプの開発\u003C/li>\u003Cli>設計検証と妥当性確認\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>製造：\u003C/strong>\u003Cul>\u003Cli>原材料の受入検査\u003C/li>\u003Cli>製造工程の各ステップ\u003C/li>\u003Cli>品質管理試験\u003C/li>\u003Cli>包装と表示\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>品質保証：\u003C/strong>\u003Cul>\u003Cli>最終製品の検査\u003C/li>\u003Cli>不適合品の管理\u003C/li>\u003Cli>是正措置と予防措置（CAPA）の実施\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>市販後管理：\u003C/strong>\u003Cul>\u003Cli>顧客苦情の処理\u003C/li>\u003Cli>市販後調査\u003C/li>\u003Cli>製品の回収\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>文書管理：\u003C/strong>\u003Cul>\u003Cli>QMS文書の作成と管理\u003C/li>\u003Cli>記録の保管と廃棄\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>教育訓練：\u003C/strong>\u003Cul>\u003Cli>従業員の教育プログラム\u003C/li>\u003Cli>力量評価\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>施設・設備管理：\u003C/strong>\u003Cul>\u003Cli>製造環境の管理\u003C/li>\u003Cli>設備・機器等の構造設備管理\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>サプライチェーン管理：\u003C/strong>\u003Cul>\u003Cli>サプライヤーの評価と選定\u003C/li>\u003Cli>購買プロセス\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの各領域において、具体的なSOPが作成され、組織全体で遵守されることで、医療機器の品質と安全性が確保されます。\u003C/p>\u003Ch3 id=\"hffbdb49730\">導入によるメリット\u003C/h3>\u003Cp>SOPを適切に導入・運用することで、医療機器メーカーは以下のようなメリットを得ることができます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>品質の向上と安定化：\u003C/strong> 標準化された手順により、製品品質のばらつきが減少し、高品質な医療機器を安定して提供できるようになります。\u003C/li>\u003Cli>\u003Cstrong>効率性の向上：\u003C/strong> 明確な手順が文書化されることで、作業の無駄や重複が削減され、業務効率が向上します。例えば、新製品の開発期間の短縮や、製造ラインの生産性向上につながります。\u003C/li>\u003Cli>\u003Cstrong>コンプライアンスの強化： \u003C/strong>規制要件に準拠したSOPを整備することで、法的要求事項への適合が容易になり、法令遵守の水準が向上します。\u003C/li>\u003Cli>\u003Cstrong>リスクの低減：\u003C/strong> 潜在的な問題を事前に特定し、対策を講じることで、製品の欠陥や回収のリスクを低減できます。\u003C/li>\u003Cli>\u003Cstrong>知識の蓄積と共有：\u003C/strong> ベストプラクティスをSOPとして文書化することで、組織の知識が蓄積され、効果的に共有されます。\u003C/li>\u003Cli>\u003Cstrong>トレーニングの効率化：\u003C/strong> 新入社員や異動者のトレーニングが、SOPを基に体系的に行えるようになり、教育の質と効率が向上します。\u003C/li>\u003Cli>\u003Cstrong>有効性の維持：\u003C/strong> SOPの定期的な見直しと更新を通じて、業務プロセスの有効性の維持が促進されます。\u003C/li>\u003Cli>\u003Cstrong>ブランド価値の向上：\u003C/strong> 高品質な製品と確立されたQMSにより、企業の信頼性とブランド価値が向上します。\u003C/li>\u003C/ol>\u003Cp>これらのメリットにより、医療機器メーカーは競争力を強化し、持続可能な成長を実現することができます。SOPの導入は初期段階では時間と労力を要しますが、長期的には大きな価値をもたらす投資と言えるでしょう。\u003C/p>\u003Ch2 id=\"h04cae1a8b1\">SOP活用の具体例\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Ch3 id=\"h26665101c3\">成功事例：ABC医療機器株式会社の人工呼吸器製造ライン\u003C/h3>\u003Cp>ABC医療機器株式会社は、高性能な人工呼吸器を製造する中堅メーカーです。同社は、品質管理の強化と生産効率の向上を目的として、人工呼吸器の製造ラインにおけるSOPの全面的な見直しと再構築を行いました。\u003C/p>\u003Cp>具体的な取り組みは以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>SOPの詳細化と視覚化：\u003C/strong> 従来のテキストベースのSOPを、写真やフローチャートを多用した視覚的なものに改訂しました。例えば、複雑な組立工程では、各ステップの写真と注意点を併記し、作業者が直感的に理解できるようにしました。\u003C/li>\u003Cli>\u003Cstrong>デジタル化の導入：\u003C/strong> 紙ベースのSOPをタブレット端末で閲覧できるシステムを導入しました。これにより、最新版のSOPへのアクセスが容易になり、改訂履歴の管理も効率化されました。\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの強化：\u003C/strong> 各工程でのチェックポイントを明確化し、作業者がリアルタイムで記録を入力できるシステムを構築しました。これにより、製品ごとの製造履歴が詳細に追跡可能となりました。\u003C/li>\u003Cli>\u003Cstrong>定期的な見直しと改善：\u003C/strong> 毎年SOP検討会を開催し、現場の意見を積極的に取り入れてSOPを改善する仕組みを確立しました。\u003C/li>\u003C/ol>\u003Cp>成功の結果：\u003C/p>\u003Cul>\u003Cli>製品の不良率が導入前と比べて40%減少しました。\u003C/li>\u003Cli>製造ラインの生産性が15%向上しました。\u003C/li>\u003Cli>FDA査察において、品質管理システムが高く評価され、指摘事項がゼロとなりました。\u003C/li>\u003Cli>従業員の満足度調査において、「作業手順の明確さ」に関する評価が20%向上しました。\u003C/li>\u003C/ul>\u003Cp>この事例から、SOPを単なる文書としてではなく、現場の実態に即した実用的なツールとして活用することの重要性が分かります。また、継続的な改善と従業員の参加を促すことで、SOPの効果を最大化できることが示されています。\u003C/p>\u003Ch3 id=\"hd0e8f84578\">失敗事例：XYZ医療システムズの血糖測定器リコール問題\u003C/h3>\u003Cp>XYZ医療システムズは、糖尿病患者向けの血糖測定器を製造する大手メーカーです。同社は、新製品の開発と市場投入を急ぐあまり、SOPの整備と遵守が不十分な状態で生産を開始してしまいました。\u003C/p>\u003Cp>問題の経緯：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>SOP作成の遅れ： \u003C/strong>SOPの更新が間に合わず、一部の作業では旧版のSOPに従って生産を開始しました。\u003C/li>\u003Cli>\u003Cstrong>教育訓練の不足：\u003C/strong> 新しい製造プロセスに関する従業員への教育にSOP教育を含めないまま、生産が開始されました。\u003C/li>\u003Cli>\u003Cstrong>品質管理プロセスの不備\u003C/strong>： 最終製品の検査SOPにおける検査基準が不明確で、特定の不具合を検出できない状態でした。\u003C/li>\u003Cli>\u003Cstrong>変更管理の失敗\u003C/strong>： 製造過程で発生した変更が、正式なSOPの改訂要否の検討を経ずに実施されていました。\u003C/li>\u003C/ol>\u003Cp>問題の顕在化：\u003C/p>\u003Cp>市場に出荷された製品の一部で、血糖値の誤表示が発生しました。患者が誤った血糖値に基づいてインスリン投与を行う危険性が指摘され、大規模なリコールが必要となりました。\u003C/p>\u003Cp>失敗の影響：\u003C/p>\u003Cul>\u003Cli>約50万台の製品がリコール対象となり、交換費用だけで数十億円の損失が発生しました。\u003C/li>\u003Cli>複数の患者から損害賠償訴訟が提起されました。\u003C/li>\u003Cli>規制当局から厳重警告を受け、一時的に新製品の認可プロセスが停止されました。\u003C/li>\u003Cli>企業イメージが大きく損なわれ、株価が30%以上下落しました。\u003C/li>\u003Cli>市場シェアが大幅に低下し、競合他社に顧客を奪われる結果となりました。\u003C/li>\u003C/ul>\u003Cp>この失敗事例から学べる教訓：\u003C/p>\u003Col>\u003Cli>SOPの重要性： 正しい作業が実施できるように明確でわかりやすい手順書を作成することが重要です。\u003C/li>\u003Cli>従業員教育の徹底： SOPの内容を従業員に十分に理解させ、実践させるための教育訓練が重要です。\u003C/li>\u003Cli>品質管理の継続的改善： 製品の特性に応じた適切な品質管理SOPを策定し、定期的に見直すことが必要です。\u003C/li>\u003Cli>変更管理の厳格化： 新製品開発や製造プロセスの変更時には、必ずSOPを更新し、それに基づいた生産を行うことが不可欠です。製造プロセスの変更は、たとえ小さなものでも正式な変更管理プロセスを経て、SOPへの影響を評価する必要があります。\u003C/li>\u003Cli>リスク管理の強化： 潜在的なリスクを事前に特定し、SOPに反映させることで、重大な問題の発生を防ぐことができます。\u003C/li>\u003C/ol>\u003Cp>この失敗事例は、医療機器業界においてSOPが単なる形式的な文書ではなく、患者の安全と企業の存続に直結する重要な要素であることを示しています。適切なSOPの策定と運用は、このような深刻な問題を未然に防ぐための重要な防御線となります。\u003C/p>\u003Ch2 id=\"hb413b2173a\">SOPの導入方法\u003C/h2>\u003Cp>医療機器業界でSOPを効果的に導入・運用するためのわかりやすい始め方ガイドを以下に示します。\u003C/p>\u003Ch3 id=\"h315faaac10\">1. SOPの必要性の理解と経営層のコミットメント\u003C/h3>\u003Cp>まず、組織全体で文書体系とSOPの位置づけ、SOPの重要性を理解し、経営層がその導入と運用にコミットすることが重要です。これにより、必要なリソースの確保や全社的な取り組みが可能になります。\u003C/p>\u003Ch3 id=\"h630d5de2cd\">2. 現状分析とギャップの特定\u003C/h3>\u003Cp>既存のプロセスを分析し、規制要件や業界標準との間にあるギャップを特定します。これにより、SOPが必要な領域や改善が必要な点が明確になります。\u003C/p>\u003Ch3 id=\"hf1d1357620\">3. SOPの作成チームの編成\u003C/h3>\u003Cp>各部門の代表者や専門家で構成されるSOP作成チームを編成します。多様な視点を取り入れることで、実用的で効果的なSOPを作成できます。\u003C/p>\u003Ch3 id=\"h0dbc3c4597\">4. SOPのテンプレートと形式の決定\u003C/h3>\u003Cp>組織全体で統一されたSOPのテンプレートと形式を決定します。一般的なSOPの構成要素には以下が含まれます：\u003C/p>\u003Cul>\u003Cli>タイトルと文書番号\u003C/li>\u003Cli>目的と適用範囲\u003C/li>\u003Cli>関連文書\u003C/li>\u003Cli>責任者と役割\u003C/li>\u003Cli>用語の定義\u003C/li>\u003Cli>手順の詳細（順序立てたステップ）\u003C/li>\u003Cli>必要な記録と様式\u003C/li>\u003Cli>改訂履歴\u003C/li>\u003C/ul>\u003Ch3 id=\"h61387d1b87\">5. SOPの作成\u003C/h3>\u003Cp>特定された各プロセスについて、以下の手順でSOPを作成します：\u003C/p>\u003Cp>a. プロセス、作業フローの詳細な分析 b. 手順のステップごとの記述 c. 関連する規制要件との整合性確認 d. 視覚的な要素（フローチャート、写真など）の追加 e. レビューと修正\u003C/p>\u003Ch3 id=\"he2650891f6\">6. SOPのレビューと承認\u003C/h3>\u003Cp>作成されたSOPは、関連部門の責任者や品質保証部門によってレビューされ、必要に応じて修正されます。最終的に、権限のある者（通常は上級管理職）による承認を得ます。\u003C/p>\u003Ch3 id=\"h47d0725542\">7. SOPの導入と教育訓練\u003C/h3>\u003Cp>承認されたSOPを関係者に周知し、適切な教育訓練を実施します。これには以下が含まれます：\u003C/p>\u003Cul>\u003Cli>SOPの概要説明\u003C/li>\u003Cli>実地訓練\u003C/li>\u003Cli>理解度の確認テスト\u003C/li>\u003C/ul>\u003Ch3 id=\"h89a685c85a\">8. SOPの運用と監視\u003C/h3>\u003Cp>SOPを実際の業務に適用し、その効果を監視します。定期的な内部監査やプロセスの観察を通じて、SOPの遵守状況と有効性を評価します。\u003C/p>\u003Cp>このとき、SOPの承認から教育訓練の期間を得たうえで運用を開始する必要があることを考慮し、いつから運用を開始するかを明確にしておくことが重要です。\u003C/p>\u003Ch3 id=\"h9f45e435b9\">9.  見直し\u003C/h3>\u003Cp>法規制の変更、定期的なレビューや現場からのフィードバックに基づいて、SOPを適時に見直しします。一定期間、更新が行われていないSOPは、更新の必要がないかを定期的に確認し、常に最適な状態を維持します。\u003C/p>\u003Ch2 id=\"ha3799191e7\">SOPの効果的な運用方法\u003C/h2>\u003Cp>SOPを効果的に運用するためには、単に文書を作成するだけでなく、組織全体でそれを活用し、継続的に改善していく必要があります。以下に、効果的な運用方法とその具体的な実践方法を説明します。\u003C/p>\u003Ch3 id=\"hb9e8ff209f\">モニタリングと評価方法\u003C/h3>\u003Col>\u003Cli>定期的な内部監査：\u003Cul>\u003Cli>頻度：少なくとも年1回、可能であれば半年に1回\u003C/li>\u003Cli>方法：監査チェックリストを用いて、SOPの遵守状況を確認\u003C/li>\u003Cli>ポイント：単なる文書や記録等の書類確認ではなく、実際の作業観察、作業者へのインタビューも含める\u003C/li>\u003C/ul>\u003C/li>\u003Cli>プロセス指標の設定と測定：\u003Cul>\u003Cli>例：手順に関する不適合の発生率、作業の所要時間、SOPの理解度など\u003C/li>\u003Cli>測定頻度：プロセスの重要度に応じて月次、四半期、半年ごとで設定\u003C/li>\u003Cli>可視化：ダッシュボードやグラフを用いて、誰もが傾向を確認できるようにする\u003C/li>\u003C/ul>\u003C/li>\u003Cli>従業員フィードバックの収集：\u003Cul>\u003Cli>方法：作業員へのアンケート、提案箱の設置など\u003C/li>\u003Cli>頻度：随時\u003C/li>\u003Cli>重要点：匿名性を確保し、率直な意見を集められるようにする\u003C/li>\u003C/ul>\u003C/li>\u003Cli>トレーサビリティの確保：\u003Cul>\u003Cli>記録作成日をSOPの版と紐付けて管理\u003C/li>\u003Cli>電子記録システムの導入により、データの追跡と分析を容易に\u003C/li>\u003C/ul>\u003C/li>\u003Cli>マネジメントレビュー：\u003Cul>\u003Cli>頻度：年1回以上\u003C/li>\u003Cli>内容：SOPの有効性、改善の必要性、リソースの適切性などを経営層で議論\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">よくある課題とその対応方法\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>課題：SOPが現場の実態と乖離している 対応：\u003C/strong>\u003Cul>\u003Cli>定期的な現場観察を実施し、SOPと実際の作業の差異を特定\u003C/li>\u003Cli>現場作業者を交えたSOP改訂ワークショップを開催\u003C/li>\u003Cli>「仮SOPプロセス」を導入し、改訂案を試行的に運用して問題点を洗い出す\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：SOPが複雑すぎて理解しにくい 対応：\u003C/strong>\u003Cul>\u003Cli>ビジュアル要素（フローチャート、写真、動画など）を積極的に活用\u003C/li>\u003Cli>重要なポイントを強調表示し、チェックリスト形式を取り入れる\u003C/li>\u003Cli>責任と役割を明確にする\u003C/li>\u003Cli>難解な専門用語には定義を付け、用語集を作成する\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：SOPの更新が追いついていない 対応：\u003C/strong>\u003Cul>\u003Cli>定期的なSOPレビューサイクルを確立（例：年一回）\u003C/li>\u003Cli>変更管理プロセスを強化し、プロセス変更時のSOP更新要否評価を必須化\u003C/li>\u003Cli>SOPの電子管理システムを導入し、更新と配布を効率化\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：従業員のSOPに対する意識が低い 対応：\u003C/strong>\u003Cul>\u003Cli>SOPの重要性に関する定期的な教育セッションを実施\u003C/li>\u003Cli>SOPの遵守度を評価指標に組み込み、人事評価と連動させる\u003C/li>\u003Cli>SOPの改善提案制度を設け、積極的な参加を奨励する\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：部門間でのSOPの整合性が取れていない 対応：\u003C/strong>\u003Cul>\u003Cli>クロスファンクショナルなSOP検討会を定期的に開催\u003C/li>\u003Cli>SOPの相互レビュープロセスを確立し、関連部門の承認を必須化\u003C/li>\u003Cli>全社的なSOP管理システムを導入し、整合性チェックを自動化\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：SOPの効果測定が適切に行われていない 対応：\u003C/strong>\u003Cul>\u003Cli>各SOPに対応したKPI（重要業績評価指標）を設定\u003C/li>\u003Cli>データ分析ツールを活用し、SOPの遵守度と品質指標の相関を分析\u003C/li>\u003Cli>定期的なSOPの有効性レビューを実施し、マネジメントレビューで経営陣に報告\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの運用方法と課題への対応を適切に実施することで、SOPを単なる文書としてではなく、組織の品質と効率を継続的に向上させるツールとして活用することができます。重要なのは、SOPを固定的なものとしてではなく、常に進化し改善されるべきものとして捉えることです。そうすることで、医療機器業界の厳しい品質要求に応えつつ、組織の競争力を高めることができるでしょう。\u003C/p>\u003Ch2 id=\"ha214098e44\">まとめ\u003C/h2>\u003Cp>SOP（標準作業手順書）は、医療機器業界において品質管理と患者安全を確保するための重要なツールです。適切に策定・運用されたSOPは、一貫した製品品質の維持、法令遵守の徹底、業務効率の向上、そしてリスク低減に大きく貢献します。しかし、SOPの効果を最大化するためには、単に文書を作成するだけでなく、組織全体でその重要性を理解し、日々の業務に適切に組み込んでいく必要があります。\u003C/p>\u003Cp>継続的な改善、従業員の積極的な参加、そして最新の規制要件や技術動向への対応を通じて、SOPを組織の強みへと転換することができます。医療機器業界の厳しい品質要求に応えつつ、イノベーションを推進するためにも、SOPの効果的な運用は不可欠です。今後も、デジタル化やAI技術の進展に合わせてSOPの在り方も進化していくことでしょう。組織の成長と患者の安全を両立させるための重要なツールとして、SOPの重要性は今後さらに高まっていくと考えられます。\u003C/p>",{"url":42,"height":43,"width":13},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/7f1893b98e0340eb9903c0cd254c5e11/sop-min.webp",788,"SOPの定義、目的、必要性を詳細に解説。医療機器業界での重要性を強調し、品質管理と患者安全確保への貢献を詳述。具体的な導入方法と効果的な運用方法を紹介し、成功・失敗事例を通じてその影響を示す。継続的改善の重要性を強調し、法令遵守、業務効率向上、リスク低減に不可欠なツールとしてのSOPの価値を明確化。組織の競争力強化と患者安全の両立に貢献する戦略的要素としての役割を明示。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":46,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[48],{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":50,"createdAt":51,"updatedAt":52,"publishedAt":51,"revisedAt":52,"title":53,"content":54,"eyecatch":55,"description":57,"reviewer":58,"category":60},"qms-capa","2024-05-31T01:48:34.349Z","2024-10-22T06:20:39.555Z","QMSのCAPA（是正処置・予防処置）とは？","\u003Ch2 id=\"h82ff0ecab2\">CAPA（是正処置・予防処置）とは？\u003C/h2>\u003Ch3 id=\"h286faa8665\">具体的な定義\u003C/h3>\u003Cp>CAPA（Corrective Action and Preventive Action）は、\u003Cstrong>QMS（品質管理監督システム）における重要なプロセスで、「是正処置」と「予防処置」の2つの要素から構成されています。\u003C/strong>\u003C/p>\u003Cul>\u003Cli>是正処置（Corrective Action）：\u003Cstrong>既に発生した\u003C/strong>問題や不適合の原因を特定し、再発を防ぐための対策を講じること。\u003C/li>\u003Cli>予防処置（Preventive Action）：潜在的な問題や不適合を\u003Cstrong>事前に特定し\u003C/strong>、その発生を未然に防ぐための対策を講じること。\u003C/li>\u003C/ul>\u003Ch3 id=\"he2485005d0\">目的\u003C/h3>\u003Cp>CAPAは、問題解決のための体系的なアプローチであり、その主な目的は、製品の品質と安全性を継続的に改善し、顧客満足度を高めるため、単に表面的な問題を解決するだけでなく、根本原因を特定し、本質的な解決策を実施することです。医療機器業界では、患者の安全を確保し、規制要件を満たすことが特に重要です。CAPAは以下を達成するために実施されます：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>品質問題の根本原因を特定し、再発を防止する\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製品やプロセスの改善を促進する\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>リスクを最小限に抑え、患者の安全を確保する\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>規制要件への適合を維持する\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>組織全体の品質文化を醸成する\u003C/strong>\u003C/li>\u003C/ul>\u003Ch2 id=\"hef3baf15e3\">CAPAの必要性\u003C/h2>\u003Ch3 id=\"h4a784b5a9d\">なぜ必要なのか？\u003C/h3>\u003Cp>CAPAプロセスが必要とされる理由は多岐にわたります：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>品質の一貫性確保：\u003C/strong> CAPAは、製品やサービスの品質を一貫して高いレベルに保つために不可欠です。問題が発生した際に迅速かつ効果的に対応し、同様の問題の再発を防ぐことで、品質の安定性が向上します。\u003C/li>\u003Cli>\u003Cstrong>リスク管理：\u003C/strong> 予防処置の側面により、潜在的な問題を事前に特定し、対処することができます。これは、品質リスクを最小限に抑え、組織の信頼を守るために重要です。\u003C/li>\u003Cli>\u003Cstrong>規制要件の遵守：\u003C/strong> 多くの業界では、CAPAプロセスの実施が規制要件となっています。特に医療機器や製薬業界では、厚生労働省をはじめ、FDAやEUの規制当局がCAPAシステムの効果的な実施を要求しています。\u003C/li>\u003Cli>\u003Cstrong>組織学習の促進：\u003C/strong> CAPAプロセスを通じて、組織は問題から学び、その知識を蓄積し共有することができます。これにより、長期的な組織能力の向上が図れます。\u003C/li>\u003Cli>\u003Cstrong>継続的改善の推進：\u003C/strong> CAPAは、組織が常に自己評価し、改善の機会を見出すためのシステマティックな方法を提供します。これにより、プロセスや製品の継続的な改善が可能になります。\u003C/li>\u003Cli>\u003Cstrong>顧客信頼度の向上：\u003C/strong> 迅速かつ効果的に問題を解決し、再発を防ぐことで、顧客からの信頼度が向上します。また、潜在的な問題を事前に防ぐことで、顧客体験の質を高めることができます。\u003C/li>\u003Cli>\u003Cstrong>コスト削減：\u003C/strong> 問題を早期に特定し解決することで、不良品の生産や顧客クレームに関連するコストを削減できます。また、予防処置により、潜在的な問題が実際の問題に発展するのを防ぐことで、長期的なコスト削減につながります。\u003Cp>\u003C/p>\u003C/li>\u003C/ol>\u003Ch3 id=\"had4a1e1a63\">対象となる活動や範囲\u003C/h3>\u003Cp>CAPAプロセスは、組織のあらゆる側面に適用可能ですが、主に以下の領域で活用されます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>製造プロセス：\u003C/strong>\u003Cul>\u003Cli>不適合製品の発生\u003C/li>\u003Cli>製造管理の不適合\u003C/li>\u003Cli>原材料の品質問題\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>品質管理監督システム：\u003C/strong>\u003Cul>\u003Cli>内部監査や外部監査での指摘事項\u003C/li>\u003Cli>品質目標の未達成\u003C/li>\u003Cli>QMSプロセスの不備\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>顧客対応：\u003C/strong>\u003Cul>\u003Cli>顧客クレームや返品\u003C/li>\u003Cli>顧客満足度調査の結果\u003C/li>\u003Cli>市場からのフィードバック\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>サプライチェーン管理：\u003C/strong>\u003Cul>\u003Cli>サプライヤーの品質問題\u003C/li>\u003Cli>納期遅延\u003C/li>\u003Cli>在庫管理の不備\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>設計・開発：\u003C/strong>\u003Cul>\u003Cli>設計変更の必要性\u003C/li>\u003Cli>新製品開発における問題\u003C/li>\u003Cli>製品性能の不足\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>規制遵守：\u003C/strong>\u003Cul>\u003Cli>規制当局からの指摘事項\u003C/li>\u003Cli>法令違反や不適合\u003C/li>\u003Cli>販売した製品に関する品質、安全性に関する問題\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>従業員教育・訓練：\u003C/strong>\u003Cul>\u003Cli>従業員のスキル不足\u003C/li>\u003Cli>ヒューマンエラー\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの領域において、実際に発生した問題（是正処置の対象）と潜在的な問題（予防処置の対象）の両方がCAPAプロセスの範囲となります。\u003C/p>\u003Ch3 id=\"hffbdb49730\">導入によるメリット\u003C/h3>\u003Cp>CAPAプロセスを適切に導入・運用することで、組織は以下のようなメリットを得ることができます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>品質の向上：\u003C/strong> 問題の根本原因に対処し、再発を防ぐことで、製品やサービスの品質が継続的に向上します。\u003C/li>\u003Cli>\u003Cstrong>顧客信頼度の向上：\u003C/strong> 品質問題を迅速に解決し、再発を防ぐことで、顧客の信頼を獲得し、満足度を高めることができます。\u003C/li>\u003Cli>\u003Cstrong>組織の効率性向上：\u003C/strong> プロセスの改善や問題の根本原因への対処により、業務の効率性が向上します。\u003C/li>\u003Cli>\u003Cstrong>リスク管理の強化：\u003C/strong> 潜在的な問題を事前に特定し対処することで、品質リスクを最小限に抑えることができます。\u003C/li>\u003Cli>\u003Cstrong>コンプライアンスの確保：\u003C/strong> 規制要件を満たすことで、法的リスクを低減し、監査や査察への対応が容易になります。\u003C/li>\u003Cli>\u003Cstrong>組織文化の改善：\u003C/strong> 問題解決と継続的改善の文化が醸成され、従業員の意識と能力が向上します。\u003C/li>\u003Cli>\u003Cstrong>意思決定の質の向上：\u003C/strong> データに基づいた問題分析と解決策の立案により、より効果的な意思決定が可能になります。\u003C/li>\u003Cli>\u003Cstrong>イノベーションの促進：\u003C/strong> 問題解決のプロセスを通じて、新しいアイデアや改善策が生まれ、イノベーションにつながる可能性があります。\u003C/li>\u003Cli>\u003Cstrong>コスト削減：\u003C/strong> 問題を早期に発見・解決し、潜在的な問題を未然に防ぐことで、不良品や顧客クレーム対応にかかるコストを削減できます。\u003C/li>\u003Cli>\u003Cstrong>競争力の強化：\u003C/strong> 品質向上とコスト削減により、市場での競争力が強化されます。\u003C/li>\u003C/ol>\u003Cp>これらのメリットは、CAPAプロセスを\u003Cstrong>単なる問題解決の手段としてではなく、組織の戦略的な改善ツールとして活用することで最大化されます。\u003C/strong>\u003C/p>\u003Ch2 id=\"h1b88918233\">CAPAの具体例\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Ch3 id=\"hd50cc3f57a\">成功事例：迅速な是正処置による製品改善\u003C/h3>\u003Cp>ある医療機器メーカーの事例を紹介します。この企業は、輸液ポンプシステムのモーター制御ユニット製造ラインで品質問題に直面し、CAPAプロセスを効果的に適用して問題を解決しました。\u003C/p>\u003Cp>\u003Cstrong>問題の概要：\u003C/strong> 顧客から、納品した機器で、高温環境下でのモーター動作不良が報告されました。\u003C/p>\u003Cp>CAPAプロセスの適用：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>問題の特定と隔離：\u003C/strong>\u003Cul>\u003Cli>不良製品を入手し、問題を再確認。\u003C/li>\u003Cli>当該問題に関する顧客の安全性を再確認（リスクアセスメント）\u003C/li>\u003Cli>影響を受けた可能性がある機器のシリアルを特定し、出荷を停止。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>根本原因分析：\u003C/strong>\u003Cul>\u003Cli>品質管理チームが詳細な調査を実施。\u003C/li>\u003Cli>原因が部品サプライヤーから供給された温度センサーの不良であることが判明。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>修正\u003C/strong>\u003Cul>\u003Cli>不良センサーのロットを特定し、そのロットを使用した製品の出荷停止。\u003C/li>\u003Cli>既に出荷された製品の回収を実施。\u003C/li>\u003Cli>不良センサーを使用したすべての在庫製品の検査と交換。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>短期的な是正処置：\u003C/strong>\u003Cul>\u003Cli>製造ラインでの温度テストの強化。\u003C/li>\u003Cli>サプライヤーに出荷前試験内容の見直しを指示。\u003C/li>\u003Cli>入荷部品の検査基準の引き上げ。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>長期的な是正処置：\u003C/strong>\u003Cul>\u003Cli>サプライヤーへの再発防止の指示。\u003C/li>\u003Cli>サプライヤー評価プロセスの見直しと強化。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>予防処置：\u003C/strong>\u003Cul>\u003Cli>同サプライヤーから供給されている類似の部品に対する品質チェックの強化。\u003C/li>\u003Cli>製品設計チームと協力し、より高温耐性のある設計への改良。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>効果の検証：\u003C/strong>\u003Cul>\u003Cli>実施した対策の有効性を確認するため、長期的なモニタリングを実施。\u003C/li>\u003Cli>顧客からのフィードバックを継続的に収集。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>結果：\u003C/strong>\u003C/p>\u003Cul>\u003Cli>問題の再発がなくなり、顧客からの信頼性が回復した。\u003C/li>\u003Cli>サプライヤー管理プロセスの改善により、全体的な部品品質が向上した。\u003C/li>\u003Cli>サプライヤーの品質意識が向上した。\u003C/li>\u003Cli>製品設計の改良により、高温環境下での性能が向上し、新たな市場機会を獲得した。\u003C/li>\u003C/ul>\u003Cp>この事例は、CAPAプロセスを通じて、単に問題を解決するだけでなく、組織全体の品質管理システムを改善し、競争力を強化できることを示しています。\u003C/p>\u003Ch3 id=\"h64d5e2ceee\">失敗事例：不十分な予防処置による品質問題の再発\u003C/h3>\u003Cp>次に、ある医療機器ソフトウェア開発会社の失敗事例を見てみましょう。この企業は、体調管理を行う医療機器プログラムの重大なセキュリティ脆弱性に対するCAPAプロセスの適用に失敗し、深刻な結果を招きました。\u003C/p>\u003Cp>\u003Cstrong>問題の概要\u003C/strong>： 顧客から、システムにセキュリティ脆弱性が存在し、顧客データへの不正アクセスの可能性があるとの報告がありました。\u003C/p>\u003Cp>CAPAプロセスの失敗：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>問題の過小評価：\u003C/strong>\u003Cul>\u003Cli>経営陣がセキュリティ問題の重大性を理解せず、対応を先送りしました。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>不十分な根本原因分析：\u003C/strong>\u003Cul>\u003Cli>技術チームが表面的な調査のみを行い、脆弱性の本質的な原因を特定できませんでした。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>短期的な対応に終始：\u003C/strong>\u003Cul>\u003Cli>一時的なパッチを適用するのみで、根本的な解決策を検討しませんでした。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>予防処置の欠如：\u003C/strong>\u003Cul>\u003Cli>同様の脆弱性が他の製品にも存在する可能性を考慮せず、包括的なセキュリティレビューを実施しませんでした。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>コミュニケーション不足：\u003C/strong>\u003Cul>\u003Cli>問題の存在と対応状況について、顧客や関係者への適切な情報開示を怠りました。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>フォローアップの不足：\u003C/strong>\u003Cul>\u003Cli>パッチ適用後の効果検証が不十分で、問題が完全に解決されたかを確認しませんでした。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>結果：\u003C/p>\u003Cul>\u003Cli>パッチが不完全だったため、セキュリティ脆弱性が残存した。\u003C/li>\u003Cli>数ヶ月後、大規模なデータ漏洩が発生し、多数の顧客情報が流出した。\u003C/li>\u003Cli>企業の評判が著しく損なわれ、顧客離れが進行した。\u003C/li>\u003Cli>規制当局からの業態許可停止と罰金が科せされた。\u003C/li>\u003Cli>集団訴訟の提起と多額の賠償金支払い。\u003C/li>\u003C/ul>\u003Cp>この事例から学べる教訓：\u003C/p>\u003Col>\u003Cli>セキュリティ問題の重大性を適切に評価し、迅速に対応することの重要性。\u003C/li>\u003Cli>根本原因分析の徹底と、長期的な解決策の必要性。\u003C/li>\u003Cli>予防的アプローチの重要性（他の製品や領域への影響の検討）。\u003C/li>\u003Cli>透明性とコミュニケーションの重要性（顧客や関係者への適切な情報開示）。\u003C/li>\u003Cli>対策実施後の効果検証の必要性。\u003C/li>\u003C/ol>\u003Cp>この失敗事例は、CAPAプロセスを\u003Cstrong>形式的に運用するのではなく、組織全体でリスク管理の重要性を認識し、体系的かつ徹底的に取り組むことの重要性\u003C/strong>を示しています。適切なCAPAプロセスの実施は、問題の再発防止だけでなく、組織の信頼性と競争力の維持にも直結することを理解する必要があります。\u003C/p>\u003Ch2 id=\"hbd4fb0d81a\">CAPAの実施方法\u003C/h2>\u003Cp>CAPAプロセスを効果的に実施するためには、体系的なアプローチが必要です。以下に、わかりやすい始め方ガイドを示します。\u003C/p>\u003Ch3 id=\"h58d35c6770\">ステップ1: 問題の特定と報告\u003C/h3>\u003Cul>\u003Cli>問題や不適合を特定するためのシステムを確立します（例：品質管理チェック、顧客フィードバック、内部監査）。\u003C/li>\u003Cli>問題を報告するための標準化されたフォーマットや手順を用意します。\u003C/li>\u003Cli>全従業員に問題報告の重要性を理解させ、積極的な報告を奨励します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h4329bb62a6\">ステップ2: 問題の評価と封じ込め\u003C/h3>\u003Cul>\u003Cli>報告された問題のリスクアセスメントを行い、リスクの重大性を評価します。\u003C/li>\u003Cli>不適合が発生している範囲を特定します。\u003C/li>\u003Cli>必要に応じて、不適合品の即時封じ込め措置を実施します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h6aa22aa57f\">ステップ3: 根本原因分析\u003C/h3>\u003Cul>\u003Cli>必要に応じて、クロスファンクショナルなチームを編成します。\u003C/li>\u003Cli>5WhyやFishbone図（特性要因図）などの手法を用いて、多角的な視点で根本原因調査のためのデータを収集し、客観的な分析を行います。\u003C/li>\u003Cli>根本原因を特定します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h1a17944a50\">ステップ4: 是正処置の立案と実施\u003C/h3>\u003Cul>\u003Cli>根本原因に対処するための具体的な再発防止策と、その有効性評価の方法を立案します。\u003C/li>\u003Cli>実施計画を作成し、責任者と期限を明確にします。\u003C/li>\u003Cli>是正処置を実施し、その進捗を監視します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h39f6b08d85\">ステップ5: 予防処置の立案と実施\u003C/h3>\u003Cul>\u003Cli>類似の問題が他の領域で発生する可能性を評価します。\u003C/li>\u003Cli>潜在的な問題を予防するための措置と、その有効性評価の方法を立案します。\u003C/li>\u003Cli>予防処置を実施し、その効果を監視します。\u003C/li>\u003C/ul>\u003Ch3 id=\"hd5e5fda34c\">ステップ6: 有効性の評価\u003C/h3>\u003Cul>\u003Cli>是正処置と予防処置の有効性を評価します。\u003C/li>\u003Cli>必要に応じて、追加の措置や修正を行います。\u003C/li>\u003Cli>長期的なモニタリング計画を立案し、実施します。\u003C/li>\u003C/ul>\u003Ch3 id=\"habf9cd5ca4\">ステップ7: 文書化と報告\u003C/h3>\u003Cul>\u003Cli>CAPAプロセスの全ステップを文書化します。\u003C/li>\u003Cli>結果を関係者に報告し、必要に応じて規制当局にも報告します。\u003C/li>\u003Cli>得られた知見を組織内で共有し、学習の機会とします。\u003C/li>\u003C/ul>\u003Ch3 id=\"h4907d38513\">ステップ8: CAPAプロセスの継続的な有効性の確認\u003C/h3>\u003Cul>\u003Cli>CAPAプロセス自体の有効性を定期的に評価します。\u003C/li>\u003Cli>プロセスの改善点を特定し、実施します。\u003C/li>\u003Cli>ベストプラクティスを組織内で共有します。\u003C/li>\u003C/ul>\u003Cp>これらのステップに従ってアプローチしていくことで、より効果的かつ効率的なCAPAプロセスの実施が可能になります。\u003Cstrong>組織の規模や業種に応じて、これらのリソースをカスタマイズし、最適化することが重要です。\u003C/strong>\u003C/p>\u003Ch2 id=\"h048d81f659\">CAPAの効果的な運用方法\u003C/h2>\u003Ch3 id=\"hb9e8ff209f\">モニタリングと評価方法\u003C/h3>\u003Cp>CAPAプロセスを効果的に運用するためには、継続的なモニタリングと評価が不可欠です。以下に主要な方法を示します：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>KPI（主要業績評価指標）の設定と追跡：\u003C/strong>\u003Cul>\u003Cli>根本原因の傾向\u003C/li>\u003Cli>CAPA完了率\u003C/li>\u003Cli>CAPA実施の適時性（期限内完了率）\u003C/li>\u003Cli>再発率（同様の問題が再発した割合）\u003C/li>\u003Cli>顧客要求事項の変化\u003C/li>\u003Cli>コスト削減効果\u003C/li>\u003C/ul>\u003Cp> これらのKPIを定期的に測定し、トレンドを分析します。\u003C/p>\u003C/li>\u003Cli>\u003Cstrong>定期的なCAPAレビュー会議：\u003C/strong>\u003Cul>\u003Cli>進行中のCAPAの状況を確認\u003C/li>\u003Cli>完了したCAPAの効果を評価\u003C/li>\u003Cli>新たなCAPAの必要性を検討\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>内部監査：\u003C/strong>\u003Cul>\u003Cli>CAPAプロセスの適切な運用を確認\u003C/li>\u003Cli>文書化の完全性と正確性を評価\u003C/li>\u003Cli>プロセスの改善機会を特定\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>マネジメントレビュー：\u003C/strong>\u003Cul>\u003Cli>CAPAの全体的な有効性を評価\u003C/li>\u003Cli>リソースの適切性を確認\u003C/li>\u003Cli>戦略的な改善方針を決定\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>トレンド分析：\u003C/strong>\u003Cul>\u003Cli>問題の種類、頻度、影響度などのデータを収集し、時系列で分析\u003C/li>\u003Cli>繰り返し発生する問題や新たな傾向を特定\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>顧客フィードバックの分析：\u003C/strong>\u003Cul>\u003Cli>顧客満足度調査の結果を分析\u003C/li>\u003Cli>苦情や返品データを評価\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>コスト分析：\u003C/strong>\u003Cul>\u003Cli>CAPA実施にかかるコストと、それによって得られた利益を比較\u003C/li>\u003Cli>長期的な品質コストの変化を追跡\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>効果的なCAPAの共有と学習：\u003C/strong>\u003Cul>\u003Cli>成功事例を組織内で共有\u003C/li>\u003Cli>ベストプラクティスを文書化し、従業員教育に活用\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">よくある課題とその対応方法\u003C/h3>\u003Cp>CAPAプロセスの運用には、いくつかの一般的な課題があります。以下に主な課題とその対応方法を示します：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>過剰なCAPAの発行：\u003C/strong> 課題：軽微な問題に対してもCAPAを発行し、リソースを圧迫する。 対応：\u003Cul>\u003Cli>問題の重大度と影響度に基づいたリスクアプローチを導入する。\u003C/li>\u003Cli>軽微な問題に対しては、簡易的な改善プロセスを設ける。\u003C/li>\u003Cli>CAPAの必要性を判断するための明確な基準を設定する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>表面的な根本原因分析： \u003C/strong>課題：本質的な原因ではなく、ケアレスミス、教育不足などの表面的な症状のみに対処してしまう。 対応：\u003Cul>\u003Cli>5Why、Fishbone図（特性要因図）などの原因分析手法を徹底的に適用し、真の根本原因（仕組み）に到達するまで掘り下げる。\u003C/li>\u003Cli>安易にヒューマンエラーと結論付けしない。\u003C/li>\u003Cli>クロスファンクショナルなチームで分析を行い、多角的な視点を確保する。\u003C/li>\u003Cli>根本原因分析のスキル向上のための教育・訓練を実施する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>フォローアップの不足：\u003C/strong> 課題：CAPAの実施後、その効果を十分に検証しない。 対応：\u003Cul>\u003Cli>CAPA完了後の効果検証プロセスを標準化する。\u003C/li>\u003Cli>有効的な効果検証を計画する。\u003C/li>\u003Cli>長期的なモニタリング計画を立案し、実施する。\u003C/li>\u003Cli>効果が不十分な場合の再評価と追加対策のプロセスを確立する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>予防処置の軽視：\u003C/strong> 課題：既に発生した問題への対処（是正処置）に焦点が当たり、予防処置が不十分になる。 対応：\u003Cul>\u003Cli>予防処置の重要性に関する教育を強化する。\u003C/li>\u003Cli>データ分析、リスクアセスメントを定期的に実施し、潜在的な問題を特定する。\u003C/li>\u003Cli>予防処置の実施と効果をKPIに含める。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>部門間の連携不足：\u003C/strong> 課題：CAPAが特定の部門の問題として扱われ、組織全体での取り組みが不足する。 対応：\u003Cul>\u003Cli>クロスファンクショナルなCAPAチームを編成する。\u003C/li>\u003Cli>部門横断的なCAPAレビュー会議を定期的に開催する。\u003C/li>\u003Cli>CAPAの進捗と成果を全社的に共有する仕組みを構築する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>文書化の不備：\u003C/strong> 課題：CAPAプロセスの各ステップが適切に文書化されない。 対応：\u003Cul>\u003Cli>標準化された文書テンプレートを導入する。\u003C/li>\u003Cli>文書化の重要性に関する教育を実施する。\u003C/li>\u003Cli>内部監査で手順、運用をレビューし、不備を是正する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>長期的な視点の欠如：\u003C/strong> 課題：短期的な問題解決に終始し、システム全体の改善につながらない。 対応：\u003Cul>\u003Cli>問題の影響を広い視点で評価する習慣をつける。\u003C/li>\u003Cli>システム思考のアプローチを導入し、問題の相互関連性を考慮する。\u003C/li>\u003Cli>安易にヒューマンエラーと結論付けしない。\u003C/li>\u003Cli>長期的な品質目標とCAPAの関連性を明確化する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>CAPAプロセスの形骸化：\u003C/strong> 課題：CAPAが形式的な手続きとして扱われ、実質的な改善につながらない。 対応：\u003Cul>\u003Cli>経営層のコミットメントを強化し、CAPAの重要性を継続的に伝達する。\u003C/li>\u003Cli>CAPAの成功事例を共有し、その価値を可視化する。\u003C/li>\u003Cli>CAPAプロセス自体の定期的な評価と改善を行う。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの課題に適切に対応することで、CAPAプロセスの効果を最大化し、組織の継続的な改善を促進することができます。重要なのは、CAPAを単なる問題解決のツールとしてではなく、組織の学習と成長のための重要な機会として捉えることです。\u003C/p>\u003Ch2 id=\"ha214098e44\">まとめ\u003C/h2>\u003Cp>CAPA（是正処置・予防処置）は、QMS（品質管理監督システム）における不可欠なプロセスであり、組織の継続的な改善と競争力の維持に重要な役割を果たします。CAPAプロセスは、\u003Cstrong>単に問題を解決するだけでなく、その根本原因に対処し、類似の問題の発生を予防することで\u003C/strong>、長期的な品質向上と顧客信頼度の向上を実現します。\u003C/p>\u003Cp>効果的なCAPAの実施には、\u003Cstrong>組織全体のコミットメント、体系的なアプローチ、そして継続的な評価と改善が必要\u003C/strong>です。問題の特定から根本原因分析、是正・予防処置の実施、そして有効性の確認に至るまで、各ステップを慎重に実行することが重要です。\u003C/p>\u003Cp>しかし、CAPAプロセスの運用には多くの課題も存在します。表面的な分析、フォローアップの不足、予防処置の軽視、部門間の連携不足など、これらの課題に適切に対応することが、CAPAの効果を最大化する鍵となります。\u003C/p>\u003Cp>最終的に、\u003Cstrong>CAPAは組織の品質文化を形成し、継続的改善のマインドセットを醸成する強力なツール\u003C/strong>となります。適切に実施されたCAPAプロセスは、問題解決能力の向上、リスクの低減、コストの削減、そして組織の競争力強化につながります。\u003C/p>\u003Cp>品質管理におけるCAPAの重要性を認識し、それを効果的に実践することで、組織は常に進化し、顧客の期待に応え続けることができるのです。\u003Cstrong>CAPAは単なる規制要件の遵守ツールではなく、組織の持続可能な成功を支える戦略的なプロセスとして位置づけられるべきです。\u003C/strong>\u003C/p>",{"url":56,"height":43,"width":13},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/336015fa4405427591f7419f1e9a8422/capa-min.webp","CAPA（是正処置・予防処置）の定義、目的、必要性を詳細に解説。品質問題の根本原因対処と再発防止への貢献を強調。問題特定から効果確認まで包括的なプロセスとしての役割を明確化。成功・失敗事例を通じてその重要性を示し、効果的な実施方法と運用上の課題への対応策を提示。継続的改善の重要性を強調し、組織の品質文化醸成と競争力強化に不可欠な戦略的ツールとしての価値を明示。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":59,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[61,66],{"id":62,"createdAt":63,"updatedAt":64,"publishedAt":63,"revisedAt":64,"name":65},"7b80a4bxeen","2024-05-20T13:39:11.467Z","2024-05-31T01:49:29.597Z","CAPA",{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":68,"createdAt":69,"updatedAt":70,"publishedAt":71,"revisedAt":70,"title":72,"content":73,"eyecatch":74,"description":77,"reviewer":78,"category":80},"software-validation","2024-10-18T01:03:58.156Z","2025-04-22T01:38:44.548Z","2024-10-18T01:21:26.769Z","QMSのソフトウェアバリデーションとは？","\u003Ch2 id=\"h3ee8ec8e0e\">\u003Cstrong>QMSのソフトウェアバリデーションとは？\u003C/strong>\u003C/h2>\u003Cp>\u003Ca href=\"https://yakuji-navi.com/blogs/about-qms\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">医療機器QMS（品質管理監督システム）\u003C/a>におけるソフトウェアバリデーションは、医療機器の安全性と有効性を確保するための重要なプロセスです。FDAの定義によると、ソフトウェアバリデーションとは、「\u003Cstrong>ソフトウェアの仕様がユーザニーズ及び意図する使用と一致していること」及び「ソフトウェアを通して実装された個々の要求が一貫して実現できていること\u003C/strong>」が明確となる試験確認と客観的な根拠の提供です。\u003C/p>\u003Ch3 id=\"h68e3d8dab0\">\u003Cstrong>QMS省令改正とバリデーション要求事項の追加\u003C/strong>\u003C/h3>\u003Cp>平成31年3月1日から、QMS省令のベースとなっている\u003Ca href=\"https://yakuji-navi.com/blogs/iso13485\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">ISO 13485\u003C/a>:2003が、ISO 13485:2016に完全移行されました。この移行に伴い、電磁的に文書や記録を作成・管理するために用いるコンピュータソフトウェアに対して、その使用にあたりバリデーションを求める旨の要求事項が追加されました。また、QMS省令においても令和3年3月26日の改正で、QMSで使用するソフトウェアバリデーションが要求事項として明言されました。\u003C/p>\u003Cp>具体的には、ISO 13485:2016の4.1.6項（QMS省令の第5条の６）において、QMSで使用するコンピュータソフトウェアの適用のバリデーションの手順の文書化が要求されています。バリデーションが適用されるコンピュータソフトウェアについては、以下の点が求められています：\u003C/p>\u003Col>\u003Cli>初回の使用前にバリデーションを実施すること\u003C/li>\u003Cli>必要な場合、そのソフトウェアそのものの変更又はその使用方法の変更に際してバリデーションを行うこと\u003C/li>\u003Cli>QMSへのコンピュータソフトウェアの使用に伴うリスク（当該ソフトウェアの使用が製品に係る医療機器の機能、性能及び安全性に及ぼす影響を含む）に応じて、当該ソフトウェアのバリデーション及び再バリデーションを行うこと\u003C/li>\u003C/ol>\u003Ch3 id=\"h42f255cad9\">\u003Cstrong>ソフトウェアバリデーションの適用範囲\u003C/strong>\u003C/h3>\u003Cp>ソフトウェアバリデーションは、以下の種類のソフトウェアに適用されます：\u003C/p>\u003Col>\u003Cli>医療機器のコンポーネント、部品、または付属品として使用されるソフトウェア\u003C/li>\u003Cli>それ自体が医療機器であるソフトウェア（例：blood establishment software）\u003C/li>\u003Cli>機器の生産に使用されるソフトウェア（例：製造設備におけるプログラムロジックコントローラ）\u003C/li>\u003Cli>製造販売業者のQMSの実現のために使用されるソフトウェア（例：教育訓練を管理するソフトウェア）\u003C/li>\u003C/ol>\u003Ch3 id=\"h286faa8665\">\u003Cstrong>具体的な定義\u003C/strong>\u003C/h3>\u003Cp>QMSのソフトウェアバリデーションには、以下の要素が含まれます：\u003C/p>\u003Col>\u003Cli>ソフトウェアの仕様が使用者側の要件、使用意図に合致していることを検証する。\u003C/li>\u003Cli>ソフトウェアから得られたアウトプットが使用意図に対して適切であり、かつ一貫性を持って得られることを検証する。\u003C/li>\u003Cli>上記2点について、客観的証拠と共に検証結果を文書化する。\u003C/li>\u003C/ol>\u003Ch3 id=\"he2485005d0\">\u003Cstrong>目的\u003C/strong>\u003C/h3>\u003Cp>QMSのソフトウェアバリデーションの主な目的は以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者の安全確保\u003C/strong>：医療機器のソフトウェアが意図した通りに動作し、患者に危害を与えるリスクを最小限に抑えること。\u003C/li>\u003Cli>\u003Cstrong>品質保証\u003C/strong>：ソフトウェアが一貫して高品質で信頼性の高い性能を発揮することを確認すること。\u003C/li>\u003Cli>\u003Cstrong>規制遵守\u003C/strong>：各国の規制要件を満たし、医療機器の承認や市販後の監視に必要な文書の品質を確保すること。\u003C/li>\u003Cli>\u003Cstrong>エラー防止\u003C/strong>：ソフトウェアの不具合やバグを早期に発見し、修正することで、QMSプロセスでの重大なエラーを防止すること。\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの確保：\u003C/strong>ソフトウェアの開発から実装、そして使用に至るまでの全過程を追跡可能にすること。\u003C/li>\u003Cli>\u003Cstrong>継続的改善：\u003C/strong>バリデーションプロセスを通じて得られた知見を、将来のソフトウェア開発やQMS全体の改善に活用すること。\u003C/li>\u003C/ol>\u003Ch2 id=\"h2f9f479990\">\u003Cstrong>ソフトウェアバリデーションの必要性\u003C/strong>\u003C/h2>\u003Cp>QMSのソフトウェアバリデーションは、QMSの運用において欠かすことのできない重要なプロセスです。ソフトウェアバリデーションの必要性は、医療機器の信頼性、有効性を確保するという根本的な要求から生じていますが、QMSを支援するソフトウェアバリデーションにも多くの重要な理由があります。\u003C/p>\u003Ch3 id=\"hffbdb49730\">\u003Cstrong>導入によるメリット\u003C/strong>\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>患者の安全性向上\u003C/strong>： QMSのソフトウェアバリデーションを通じて、QMSで使用するのソフトウェアが意図した通りに機能することを確認することで、製品の信頼性に対する潜在的なリスクを大幅に低減できます。これは関節的に患者の安全性向上につながります。\u003C/li>\u003Cli>\u003Cstrong>品質の一貫性確保：\u003C/strong> バリデーションプロセスにより、ソフトウェアの品質が一定水準以上に保たれることが保証されます。これにより、QMSプロセスの信頼性が向上し、QMSプロセスでの高品質なアウトプットを提供することができます。\u003C/li>\u003Cli>\u003Cstrong>コスト削減\u003C/strong>： 初期段階でのバグや不具合の発見により、ソフトウェア使用開始後のデータ修正にかかるコストを削減できます。長期的には、品質管理にかかる総コストの削減につながります。\u003C/li>\u003Cli>\u003Cstrong>規制遵守の証明\u003C/strong>： 適切なソフトウェアバリデーションを実施することで、各国の規制要件への適合を示すことができます。これは、製品の市場承認プロセスを円滑にし、規制当局との良好な関係を維持するのに役立ちます。\u003C/li>\u003Cli>\u003Cstrong>企業イメージの向上\u003C/strong>： 厳格な品質管理プロセスを実施していることは、企業の信頼性と評判を高めます。これは顧客（医療機関や患者）からの信頼獲得につながり、市場での競争力を向上させます。\u003C/li>\u003Cli>\u003Cstrong>継続的改善の促進\u003C/strong>： バリデーションプロセスを通じて得られた知見は、将来のQMS運用や品質管理プロセスの改善に活用できます。これにより、組織全体の品質文化が醸成されます。\u003C/li>\u003C/ol>\u003Ch3 id=\"had4a1e1a63\">\u003Cstrong>対象となる活動や範囲\u003C/strong>\u003C/h3>\u003Cp>QMSのソフトウェアバリデーションは、QMS全体にわたって使用されるソフトウェアに適用されます。具体的には以下のような活動や範囲が対象となります：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>ソフトウェアの設計開発：\u003C/strong>\u003Cul>\u003Cli>自社で設計開発するソフトウェア\u003C/li>\u003Cli>市販ソフトウェアに追加する独自のプログラム\u003C/li>\u003Cli>市販のソフトウェア\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>医療機器の生産・製造段階で使用するソフトウェア：\u003C/strong>\u003Cul>\u003Cli>統計的手法ツール：サンプル数の検討、検定と推定などで使用するシステム\u003C/li>\u003Cli>製造、試験及び検査で使用する機器のソフトウェア\u003C/li>\u003Cli>製造管理システム（MES）\u003C/li>\u003Cli>製品トレーサビリティシステム（製品出入庫システム）\u003C/li>\u003Cli>製造設備、試験検査機器の保守管理ソフトウェア\u003C/li>\u003Cli>不適合製品の管理システム\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>QMSの支援システムで使用するソフトウェア：\u003C/strong>\u003Cul>\u003Cli>文書、記録管理システム\u003C/li>\u003Cli>教育訓練管理システム\u003C/li>\u003Cli>苦情処理システム\u003C/li>\u003Cli>QMS各プロセスで得たデータのトレンド分析ソフトウェア\u003C/li>\u003Cli>CAPAシステム\u003C/li>\u003Cli>内部監査管理システム\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの活動や範囲は、QMSプロセスの複雑さ、そして使用目的によって異なる場合があります。例えば、電子承認、製造記録管理などを伴うシステムでは、より厳格で包括的なバリデーションが要求されます。一方、単なる電子文書の保管、閲覧システムのような比較的リスクの低いシステムでも、適切なレベルのバリデーションが必要です。\u003C/p>\u003Cp>また、自社がソフトウェアの設計に関与するかしないかで、バリデーション範囲が異なります。\u003C/p>\u003Cp>例えば、自社で製品トレーサビリティシステムを開発する場合は、ソフトウェア設計開発段階でのバリデーションが必要となりますが、市販の文書管理ソフトウェアを導入する場合は、主にソフトウェア運用方法のバリデーションが必要となります。\u003C/p>\u003Cp>ただし、一般的に、医療機器の機能、性能及び安全性、あるいは製品又は規制要求事項への適合性に影響を及ぼさないコンピュータソフトウェアであれば、その適用のバリデーションは不要とすることができます。\u003C/p>\u003Ch2 id=\"h67b05c2240\">\u003Cstrong>ソフトウェアバリデーションの具体例\u003C/strong>\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Cp>QMSのソフトウェアバリデーションの実践を理解するために、医療機器業界における成功事例と失敗事例をそれぞれ1つずつ紹介します。これらの事例を通じて、ソフトウェアバリデーションの重要性と適切な実施方法について具体的に学ぶことができます。\u003C/p>\u003Ch3 id=\"hfecd05fbd8\">\u003Cstrong>成功事例：文書管理システムのソフトウェアバリデーション\u003C/strong>\u003C/h3>\u003Cp>架空の医療機器メーカー「ヘルスケアテック株式会社」が導入した文書管理システムについて考えてみましょう。このシステムは、作成した文書に文書番号を割り当てたうえで、審査、承認を経て、文書の保管、配布、閲覧を管理する機能を持っています。\u003C/p>\u003Cp>ヘルスケアテック社は、開発の初期段階からQMSのソフトウェアバリデーションを重視し、以下のようなアプローチを採用しました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>リスク分析\u003C/strong>： 開発チームは、ソフトウェアの各機能に対して詳細なリスク分析を実施しました。特に、文書の真正性、見読性、保存性に関連するリスクに焦点を当てました。\u003C/li>\u003Cli>\u003Cstrong>要件の明確化\u003C/strong>： 品質保証部門や文書使用者の意見を取り入れ、システムの要件を明確に定義しました。これには、アクセス制限、データ転送の信頼性、ユーザーインターフェースの使いやすさなどが含まれます。\u003C/li>\u003Cli>\u003Cstrong>段階的なテスト\u003C/strong>： ソフトウェアの導入過程で、設置時適格性確認、運転時適格性確認を段階的に実施しました。とくに運転時適格性確認では、誤った操作によるエラー表示確認を重点的に実施し、各段階で発見された問題は即座に修正され、再テストされました。\u003C/li>\u003Cli>\u003Cstrong>使用開始後のフィードバック\u003C/strong>： システムの運用を開始してから3か月間、フォローアップ期間として、実際の使用者からのフィードバックを求め、分析を実施しました。これにより、実際の使用環境での性能や使いやすさを確認しました。\u003C/li>\u003Cli>\u003Cstrong>徹底的な文書化\u003C/strong>： バリデーションの全過程を詳細に文書化し、トレーサビリティを確保しました。これにより、規制当局の審査にも迅速に対応することができました。\u003C/li>\u003C/ol>\u003Cp>結果として、ヘルスケアテック社で導入した文書管理システムは、高い精度と信頼性を持つシステムであることが検証されました。システム導入後1年間で、重大な不適合の報告はゼロ件、ユーザー満足度は95%以上を達成しました。また、規制当局の査察でもソフトウェアバリデーションの優れた実践例として高く評価されました。\u003C/p>\u003Ch3 id=\"h2c22e7624a\">\u003Cstrong>失敗事例：内部監査管理システムのソフトウェアバリデーション不足\u003C/strong>\u003C/h3>\u003Cp>一方で、架空の医療機器メーカー「メディカルソリューションズ株式会社」で導入した内部監査管理システムの事例を見てみましょう。この会社は、内部監査管理におけるリソース不足を取り戻すために、ソフトウェアバリデーションプロセスを簡略化してしまいました。\u003C/p>\u003Cp>以下のような問題点がありました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>性能不足\u003C/strong>：価格重視でソフトウェアを選定したため、必要とする性能が不十分でした。\u003C/li>\u003Cli>\u003Cstrong>不十分なリスク分析\u003C/strong>： システムの潜在的なリスクを十分に分析せず、特に内部監査報告書と指摘事項関連文書のトレーサビリティに関するリスクを見逃しました。\u003C/li>\u003Cli>\u003Cstrong>限定的なテスト範囲\u003C/strong>： 主要な機能のみをテストし、誤操作によるエラー確認を省略しました。\u003C/li>\u003Cli>\u003Cstrong>実環境テストの不足\u003C/strong>： 実際の使用環境を模したテストを十分に行わず、理想的な条件下でのテストのみに依存しました。\u003C/li>\u003Cli>\u003Cstrong>文書化の不備\u003C/strong>： テスト結果や修正履歴の文書化が不完全で、問題発生時のトレースバックが困難でした。\u003C/li>\u003Cli>\u003Cstrong>変更管理の不適切さ\u003C/strong>：最終段階で行われた手順変更に対して、十分な検証を実施しませんでした。\u003C/li>\u003C/ol>\u003Cp>この結果、メディカルソリューションズ社の内供監査管理システムは導入後、深刻な問題に直面しました：\u003C/p>\u003Cul>\u003Cli>FDAの査察により、内部監査における指摘への是正措置が未完了なまま放置されているとの指摘が行われました。\u003C/li>\u003Cli>調査の結果、特定の条件下で文書のトレーサビリティが取れておらず、未完了な対応が完了済と報告される可能性があることが判明し、未完了なまま放置されていた是正措置が発生する事態が発生しました。\u003C/li>\u003Cli>問題への対処に時間を要したため、FDAよりWarning Letterが発出され、USへの新製品導入ができなくなりました。\u003C/li>\u003Cli>会社はUS市場の新製品販売戦略を余儀なくされ、ブランドイメージも大きく損なわれました。\u003C/li>\u003C/ul>\u003Cp>この失敗事例から、QMSのソフトウェアバリデーションの重要性が明確に示されています。適切なバリデーションプロセスを省略したことで、QMSの信頼性が脅かされ、企業にも深刻な影響が及びました。\u003C/p>\u003Cp>これらの事例は、QMSのソフトウェアバリデーションが単なる規制要件の遵守以上の意味を持つことを示しています。適切に実施すればQMSデータの品質と信頼性を大幅に向上させ、不適切な実施は重大な結果をもたらす可能性があります。医療機器業界において、ソフトウェアバリデーションは企業の成功を左右する極めて重要なプロセスなのです。\u003C/p>\u003Ch2 id=\"h0d4907514b\">\u003Cstrong>ER/ES指針とQMSのソフトウェアバリデーション\u003C/strong>\u003C/h2>\u003Cp>\u003Ca href=\"https://www.mhlw.go.jp/web/t_doc?dataId=00ta8216&dataType=1&pageNo=1\">ER/ES指針（電磁的記録・電子署名ガイダンス）\u003C/a>は、QMS省令における作成、保管が求められる文書又は記録について、紙媒体から電磁的な文書又は記録へ移行する、あるいは、電磁的な文書又は記録を新たに作成し、保管する際に、適合すべき要求事項の1つとなります。\u003C/p>\u003Ch3 id=\"h0de62b3b0f\">\u003Cstrong>ER/ES指針の適用範囲\u003C/strong>\u003C/h3>\u003Cp>ER/ES指針の適用範囲は、次のように規定されています：\u003C/p>\u003Col>\u003Cli>医薬品医療機器法及び関連法令に基づいて、医療機器の承認又は許可等並びに適合性認証機関の登録等に係る申請、届出又は報告等にあたって提出資料として電磁的記録又は電子署名を利用する場合\u003C/li>\u003Cli>原資料、その他医薬品医療機器法及び関連法令により保存が義務づけられている資料として電磁的記録及び電子署名を利用する場合\u003C/li>\u003C/ol>\u003Ch3 id=\"h7431263647\">\u003Cstrong>ER/ES指針の主な要求事項\u003C/strong>\u003C/h3>\u003Cp>ER/ES指針では、電磁的記録の真正性、見読性、保存性の要求事項が規定されています：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>真正性：\u003C/strong>\u003Cul>\u003Cli>電磁的記録が完全、正確であり、かつ信頼できるとともに、作成、変更、削除の責任の所在が明確であること。\u003C/li>\u003Cli>システムのセキュリティを保持するための規則、手順が文書化されており、適切に実施されていること。\u003C/li>\u003Cli>保存情報の作成者が明確に識別できること。変更する場合は、変更前の情報も保存されるとともに、変更者が明確に識別できること。\u003C/li>\u003Cli>電磁的記録のバックアップ手順が文書化されており、適切に実施されていること。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>見読性：\u003C/strong>\u003Cul>\u003Cli>電磁的記録の内容を人が読める形式で出力（ディスプレイ装置への表示、紙への印刷、電磁的記録媒体へのコピー等）ができること。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>保存性：\u003C/strong>\u003Cul>\u003Cli>医薬品医療機器法、QMS省令、その関連通知等に定められる保存期間内において、真正性及び見読性が確保された状態で保存すること。\u003C/li>\u003Cli>電磁的記録の管理等の手順を文書化することが求められる。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h6d29f6bda0\">\u003Cstrong>QMSのソフトウェアバリデーションとER/ES指針の関係\u003C/strong>\u003C/h3>\u003Cp>QMSのソフトウェアバリデーションを実施する際には、ER/ES指針の要求事項も考慮に入れる必要があります。特に、電磁的記録を作成し、保管するシステムは、コンピュータ・システム・バリデーション（CSV）によりシステムの信頼性が確保されていることが前提とされています。\u003C/p>\u003Cp>CSVとは、システムが電磁的な文書及び記録の完全性、正確性、信頼性の確保及び意図された要件を満たしていることを保証し、文書化することです。CSVを通じて、以下の点を確認する必要があります：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>システムが要求事項（真正性、見読性、保存性及び意図された要件）通りに動作すること\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>運用手順書に従って運用した際に、上記の要求事項を満たすこと\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>バリデーションの結果が適切に文書化されていること\u003C/strong>\u003C/li>\u003C/ol>\u003Cp>QMSのソフトウェアバリデーションとER/ES指針に基づくCSVを適切に実施することで、電磁的記録及び電子署名を利用するシステムの信頼性を確保し、規制要件に適合したQMSを構築・維持することができます。\u003C/p>\u003Ch2 id=\"ha038cd9aa3\">\u003Cstrong>ソフトウェアバリデーションの実施方法\u003C/strong>\u003C/h2>\u003Cp>QMSのソフトウェアバリデーションを効果的に実施するためには、系統的なアプローチが必要です。以下に、医療機器メーカーがソフトウェアバリデーションを実施する際の基本的なステップとガイドラインを示します。\u003C/p>\u003Cp>\u003Cstrong>わかりやすい始め方ガイド（ステップ3～7はソフトウェアの設計、カスタマイズを行う場合に適用）\u003C/strong>\u003C/p>\u003Ch3 id=\"h370212e66b\">1. バリデーション計画の策定：\u003C/h3>\u003Cul>\u003Cli>プロジェクトの目的と範囲を定義します。\u003C/li>\u003Cli>バリデーション活動のスケジュールと責任者を決定します。\u003C/li>\u003Cli>使用する方法論と基準を選択します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h3a68812a1e\">2. リスク分析の実施：\u003C/h3>\u003Cul>\u003Cli>ソフトウェアの使用目的と潜在的なリスクを特定します。\u003C/li>\u003Cli>リスクの重大度と発生確率を評価します。\u003C/li>\u003Cli>リスク軽減策を検討し、実装計画を立てます。\u003C/li>\u003C/ul>\u003Ch3 id=\"h67bab9db92\">3. 要件の定義と文書化：\u003C/h3>\u003Cul>\u003Cli>ソフトウェアの機能要件と非機能要件を明確に定義します。\u003C/li>\u003Cli>ユーザー要求仕様書（URS）とソフトウェア要求仕様書（SRS）を作成します。\u003C/li>\u003C/ul>\u003Ch3 id=\"he1a8910bd1\">4. 設計の検証：\u003C/h3>\u003Cul>\u003Cli>ソフトウェア設計が要件を満たしているかをレビューします。\u003C/li>\u003Cli>設計文書（ソフトウェア設計仕様書など）を作成し、承認します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h38ee2a23d6\">5. コード開発とレビュー：\u003C/h3>\u003Cul>\u003Cli>定義された設計に基づいてコードを開発します。\u003C/li>\u003Cli>コードレビューを実施し、プログラミング標準への準拠を確認します。\u003C/li>\u003C/ul>\u003Ch3 id=\"hd387dea214\">6. テスト計画の策定と実行：\u003C/h3>\u003Cul>\u003Cli>単体テスト、結合テスト、システムテスト、受け入れテストの計画を作成します。\u003C/li>\u003Cli>テストケースとテスト手順を定義します。\u003C/li>\u003Cli>各段階のテストを実施し、結果を文書化します。\u003C/li>\u003C/ul>\u003Ch3 id=\"ha16be19515\">7. トレーサビリティの確保：\u003C/h3>\u003Cul>\u003Cli>要件、設計、コード、テストケース間のトレーサビリティマトリックスを作成します。\u003C/li>\u003Cli>全ての要件がテストされていることを確認します。\u003C/li>\u003C/ul>\u003Ch3 id=\"hbd13fbfc9c\">8. 実環境での検証：\u003C/h3>\u003Cul>\u003Cli>ソフトウェアの仕様、版、付属品が全て揃っていることを確認します。（設置時適格性確認）\u003C/li>\u003Cli>実際の使用環境を模した条件下でのテストを実施します。（運転時適格性確認）\u003C/li>\u003Cli>ユーザビリティテストを含め、エンドユーザーの視点からの評価を行います。\u003C/li>\u003C/ul>\u003Ch3 id=\"hfc5e8c760c\">9. バリデーション報告書の作成：\u003C/h3>\u003Cul>\u003Cli>バリデーション活動の結果をまとめた報告書を作成します。\u003C/li>\u003Cli>発見された問題点とその解決策を文書化します。\u003C/li>\u003C/ul>\u003Ch3 id=\"hd1ee43aec3\">10. 変更管理とメンテナンス：\u003C/h3>\u003Cul>\u003Cli>ソフトウェアの変更に対する管理プロセスを確立します。\u003C/li>\u003Cli>変更後の再バリデーション手順を定義します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h5b8f73e456\">\u003Cstrong>必要な資料やリソース一覧\u003C/strong>\u003C/h3>\u003Cp>QMSのソフトウェアバリデーションを適切に実施するためには、以下の資料やリソースが必要です：\u003C/p>\u003Cp>*はソフトウェアを設計、カスタマイズする場合のみ。\u003C/p>\u003Col>\u003Cli>規制文書（参照)：\u003Cul>\u003Cli>ISO/TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems (医療機器ソフトウェア－第 2 部:医療機器の品質システムで使用するソフトウェアのバリデーション)\u003C/li>\u003Cli>FDA's General Principles of Software Validation\u003C/li>\u003C/ul>\u003C/li>\u003Cli>社内文書：\u003Cul>\u003Cli>品質マニュアル\u003C/li>\u003Cli>ソフトウェア設計開発手順書*\u003C/li>\u003Cli>（ソフトウェア）バリデーション手順書\u003C/li>\u003Cli>リスク管理手順書\u003C/li>\u003C/ul>\u003C/li>\u003Cli>プロジェクト固有文書：\u003Cul>\u003Cli>プロジェクト計画書\u003C/li>\u003Cli>要求仕様書（URS、SRS）\u003C/li>\u003Cli>設計仕様書*\u003C/li>\u003Cli>テスト計画書*\u003C/li>\u003Cli>トレーサビリティマトリックス*\u003C/li>\u003Cli>バリデーション計画書\u003C/li>\u003Cli>バリデーション報告書\u003C/li>\u003C/ul>\u003C/li>\u003Cli>ツールとソフトウェア：\u003Cul>\u003Cli>要件管理ツール（例：JIRA、Confluence）*\u003C/li>\u003Cli>ソースコード管理システム（例：Git、SVN）*\u003C/li>\u003Cli>テスト管理ツール（例：TestRail、qTest）*\u003C/li>\u003Cli>静的コード分析ツール（例：SonarQube）*\u003C/li>\u003Cli>動的解析ツール（例：Valgrind）*\u003C/li>\u003C/ul>\u003C/li>\u003Cli>人的リソース：\u003Cul>\u003Cli>プロジェクトマネージャー*\u003C/li>\u003Cli>ソフトウェア開発者*\u003C/li>\u003Cli>QAエンジニア\u003C/li>\u003Cli>バリデーションスペシャリスト\u003C/li>\u003Cli>規制対応の専門家\u003C/li>\u003C/ul>\u003C/li>\u003Cli>トレーニング資料：\u003Cul>\u003Cli>ソフトウェアバリデーションの基礎\u003C/li>\u003Cli>規制要件の解説\u003C/li>\u003Cli>リスク管理の手法\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの資料やリソースを適切に活用することで、効果的なQMSのソフトウェアバリデーションを実施することができます。重要なのは、単に形式的にプロセスを踏むのではなく、各ステップの意義を理解し、QMSデータの品質と信頼性の向上につなげることです。また、バリデーションプロセスはQMSプロセス全体を通じて継続的に実施され、改善されるべきものであることを忘れてはいけません。\u003C/p>\u003Ch2 id=\"h516605b5e7\">\u003Cstrong>ソフトウェアバリデーションの効果的な運用方法\u003C/strong>\u003C/h2>\u003Cp>QMSのソフトウェアバリデーションを効果的に運用するためには、継続的なモニタリングと評価が不可欠です。また、よくある課題に対して適切に対応することも重要です。以下に、効果的な運用方法と課題への対応策を詳しく説明します。\u003C/p>\u003Cp>*はソフトウェアを設計、カスタマイズする場合のみ。\u003C/p>\u003Cp>\u003Cstrong>モニタリングと評価方法\u003C/strong>\u003C/p>\u003Col>\u003Cli>\u003Cstrong>メトリクスの設定と追跡*：\u003C/strong>\u003Cul>\u003Cli>バグ検出率：開発段階ごとに発見されるバグの数を追跡し、品質向上の進捗を評価します。\u003C/li>\u003Cli>テストカバレッジ：コードカバレッジやシナリオカバレッジを測定し、テストの網羅性を確認します。\u003C/li>\u003Cli>バリデーション活動の効率性：計画vs実績の時間やコストを比較し、プロセスの効率を評価します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>定期的なレビュー*：\u003C/strong>\u003Cul>\u003Cli>四半期～年次にバリデーションしたプロセスの効果性を評価します。\u003C/li>\u003Cli>ステークホルダー（開発者、QA、規制対応チームなど）からのフィードバックを収集し、改善点を特定します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>監査の実施：\u003C/strong>\u003Cul>\u003Cli>内部監査：年1回以上、社内の監査チームによるバリデーションプロセスの監査を実施します。\u003C/li>\u003Cli>外部監査：認証機関や規制当局による監査に備え、定期的に外部コンサルタントによる模擬監査を行います。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>市販後監視：\u003C/strong>\u003Cul>\u003Cli>使用者からのフィードバックやクレームを分析し、ソフトウェアバリデーションプロセスの改善につなげます。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>トレンド分析：\u003C/strong>\u003Cul>\u003Cli>長期的なデータを分析し、バリデーションプロセスの効果性のトレンドを把握します。\u003C/li>\u003Cli>業界標準や最新のベストプラクティスと比較し、自社のプロセスを評価します。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>よくある課題とその対応方法\u003C/strong>\u003C/p>\u003Col>\u003Cli>リソースの制約：\u003Cul>\u003Cli>課題：バリデーション活動に十分な時間や人員を割り当てることが難しい。\u003C/li>\u003Cli>対応：リスクベースアプローチを採用し、重要度の高い機能や高リスクの領域に重点的にリソースを配分します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>変更管理の複雑さ*：\u003Cul>\u003Cli>課題：頻繁な変更要求に対して、適切な再バリデーションを行うことが困難。\u003C/li>\u003Cli>対応：変更の影響範囲を正確に特定するためのトレーサビリティマトリックスを整備します。変更の重要度に応じた再バリデーションの手順を明確に定義し、運用します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>要求事項の不明確さ：\u003Cul>\u003Cli>課題：規制当局の要求事項が明確でなく、バリデーション方法の確立が追いつかない。\u003C/li>\u003Cli>対応：継続的な教育とトレーニングを実施し、最新の技術動向やバリデーション手法を学習します。業界団体や規制当局のガイダンスを定期的にチェックし、必要に応じてプロセスを更新します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>文書化の負担：\u003Cul>\u003Cli>課題：バリデーション活動の詳細な文書化に多くの時間がかかる。\u003C/li>\u003Cli>対応：テンプレートの整備や文書管理システムの導入により、文書化作業を効率化します。重要な情報に焦点を当て、不要な冗長性を排除します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>クラウドや第三者製ソフトウェアの統合：\u003Cul>\u003Cli>課題：クラウドサービスや第三者製ソフトウェアを使用する際のバリデーション範囲の定義が難しい。\u003C/li>\u003Cli>対応：サプライヤー評価プロセスを確立し、第三者のバリデーション文書管理方法を適切に評価します。リスクアプローチに従って、製品の品質、安全性に影響を与える自社プロセスに重点を置いたバリデーション計画を策定します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>グローバル展開時の規制対応：\u003Cul>\u003Cli>課題：異なる国や地域の規制要件に対応したバリデーションの実施が複雑。\u003C/li>\u003Cli>対応：グローバルな規制要件のマッピングを行い、共通の基盤となるバリデーションプロセスを確立します。地域固有の要件に対しては、追加のモジュールとして対応を考えます。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>アジャイル開発との整合性：\u003Cul>\u003Cli>課題：アジャイル開発手法とバリデーションプロセスの整合性を取ることが難しい。\u003C/li>\u003Cli>対応：短期間で完了させるバリデーションアプローチを採用し、継続的な検証と妥当性確認を実施します。規制要件とアジャイルプラクティス（短期に成果を出し続ける）を両立させるためのガイドラインを策定します。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの課題に適切に対応し、効果的なモニタリングと評価を継続的に実施することで、QMSのソフトウェアバリデーションプロセスを常に最適な状態に保つことができます。重要なのは、形式的な遵守ではなく、実質的な品質と信頼性の向上につながるバリデーションを目指すことです。また、組織全体でバリデーションの重要性を理解し、品質文化を醸成することが、長期的な成功につながります。\u003C/p>\u003Ch2 id=\"h091fce8b5f\">\u003Cstrong>７. まとめ\u003C/strong>\u003C/h2>\u003Cp>QMSのソフトウェアバリデーションは、QMSの信頼性と有効性を確保するための不可欠なプロセスです。ISO 13485:2016への移行に伴い、QMSで使用するコンピュータソフトウェアのバリデーションが明確に要求されるようになりました。また、文書管理、記録管理に関しては、ER/ES指針に基づくCSVの実施も、電磁的記録及び電子署名を利用するシステムの信頼性確保に重要な役割を果たしています。\u003C/p>\u003Cp>適切に実施されることで、QMSのソフトウェアバリデーションは以下のような効果をもたらします：\u003C/p>\u003Col>\u003Cli>製品の品質、信頼性を向上させる\u003C/li>\u003Cli>規制要件を満たし、市場承認プロセスを円滑にする\u003C/li>\u003Cli>長期的なコスト削減につながる\u003C/li>\u003Cli>企業の信頼性と評判を高める\u003C/li>\u003C/ol>\u003Cp>医療機器メーカーは、自社の製品や使用するソフトウェアのリスクレベルに応じて、適切なバリデーション手法を選択し、実施することが重要です。また、技術の進歩や規制環境の変化に応じて、バリデーションプロセスを継続的に改善していくことが求められます。\u003C/p>",{"url":75,"height":76,"width":13},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/b634068d0d40427d876864952c96d0a5/software-min.webp",887,"医療機器QMSにおけるソフトウェアバリデーションの重要性と実施方法を解説。ISO 13485:2016対応や、ER/ES指針との関連性、具体的な成功事例と失敗事例を紹介。効果的な運用方法や課題への対応策も網羅的に解説。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":79,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[81,85],{"id":82,"createdAt":83,"updatedAt":83,"publishedAt":83,"revisedAt":83,"name":84},"zok07f3-fr","2024-10-16T06:41:44.552Z","バリデーション",{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":87,"createdAt":88,"updatedAt":89,"publishedAt":90,"revisedAt":89,"title":91,"content":92,"eyecatch":93,"description":97,"reviewer":98,"category":100},"iso13485","2024-05-31T02:18:04.197Z","2025-04-18T02:45:44.018Z","2024-09-24T03:47:23.640Z","ISO13485とは？：医療機器の国際品質規格への対応法","\u003Ch2 id=\"h80af1be0d4\">\u003Cstrong>ISO13485の概要と医療機器QMSにおける位置づけ\u003C/strong>\u003C/h2>\u003Cp>ISO13485は、\u003Cstrong>医療機器の品質マネジメントシステム（QMS）に関する国際規格\u003C/strong>です。この規格は、医療機器の設計・開発、製造、保管、流通、据付け、サービス提供など、医療機器のライフサイクルにかかわる活動を行う組織が、一貫して安全で有効な医療機器を提供するために必要な品質システム要求事項を規定しています。\u003C/p>\u003Cp>医療機器業界では、製品の安全性と有効性が人命に直結するため、厳格な品質管理が求められます。ISO13485は、このような医療機器特有の要求事項を考慮した規格として、世界各国の規制当局から認められており、\u003Cstrong>医療機器の国際取引における共通言語\u003C/strong>としての役割も果たしています。\u003C/p>\u003Cp>日本では、「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（医薬品医療機器等法、通称：薬機法）」に基づく「医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令（QMS省令）」が、ISO13485を基盤として制定されています。\u003C/p>\u003Cp>QMS省令は、ISO13485に日本独自の追加要求事項が加えられた内容となっており、\u003Cstrong>基本的にQMS省令へ適合していれば、ISO13485の要件は満たしていると考えられます。\u003C/strong>\u003C/p>\u003Ch3 id=\"hd5c80bf7d2\">\u003Cstrong>医療機器QMSの国際的な枠組み\u003C/strong>\u003C/h3>\u003Cp>医療機器の品質管理に関する国際的な枠組みとして、以下のような連携があります：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>IMDRF\u003C/strong>（International Medical Device Regulators Forum：国際医療機器規制当局フォーラム）が国際的な医療機器規制の調和を推進\u003C/li>\u003Cli>\u003Cstrong>ISO13485\u003C/strong>が国際的な医療機器QMSの基準として広く採用\u003C/li>\u003Cli>各国規制当局が、ISO13485を基礎として、自国の医療機器規制を整備\u003C/li>\u003C/ul>\u003Cp>こうした国際的な調和の取り組みにより、医療機器メーカーは異なる国の市場に製品を供給する際の規制対応の負担軽減が図られています。\u003C/p>\u003Ch2 id=\"h60e453ee23\">\u003Cstrong>ISO13485の歴史と2016年版の特徴\u003C/strong>\u003C/h2>\u003Ch3 id=\"h898db926ab\">\u003Cstrong>規格の発展と改訂の歴史\u003C/strong>\u003C/h3>\u003Cp>ISO13485の変遷を理解することは、現行規格の要求事項の背景を把握する上で重要です：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>1996年\u003C/strong>: ISO13485:1996として初版発行（ISO9001:1994をベースに医療機器特有の要求事項を追加）\u003C/li>\u003Cli>\u003Cstrong>2003年\u003C/strong>: ISO13485:2003として改訂（ISO9001:2000との整合性を考慮しつつ、医療機器固有の要件を強化）\u003C/li>\u003Cli>\u003Cstrong>2016年\u003C/strong>: ISO13485:2016として最新改訂（ISO9001:2008との整合性、およびISO9001：2015の改訂内容を考慮し、リスクアプローチの強化、サプライチェーン管理の拡充など）\u003C/li>\u003C/ul>\u003Ch3 id=\"hba0b1a51a7\">\u003Cstrong>ISO13485:2016の主な特徴\u003C/strong>\u003C/h3>\u003Cp>現行のISO13485:2016版は、前版から約13年ぶりの大幅な改訂となりました。主な特徴として：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>リスクアプローチの拡大\u003C/strong>: QMSのすべての側面にリスク管理の概念を適用\u003C/li>\u003Cli>\u003Cstrong>バリデーション要求の強化\u003C/strong>: 特にソフトウェアバリデーションやプロセスバリデーションの要求が詳細化\u003C/li>\u003Cli>\u003Cstrong>サプライチェーン管理の強化\u003C/strong>: 購買管理、外部委託プロセスの管理が拡充\u003C/li>\u003Cli>\u003Cstrong>フィードバックシステムの強化\u003C/strong>: 市販後の情報収集、苦情処理と是正・予防措置への活用を強化\u003C/li>\u003Cli>\u003Cstrong>ISO9001:2015との相違点\u003C/strong>: ISO9001が採用した高水準構造（HLS）を採用せず、医療機器業界の従来の構造を維持\u003C/li>\u003C/ol>\u003Cp>日本では2018年3月にJIS Q 13485:2018として発行され、QMS省令との整合性が考慮されています。\u003C/p>\u003Ch3 id=\"hea162ace07\">\u003Cstrong>ISO9001との関係\u003C/strong>\u003C/h3>\u003Cp>ISO13485はISO9001をベースにしていますが、以下の点で重要な違いがあります：\u003C/p>\u003Cul>\u003Cli>ISO13485は\u003Cstrong>規制目的のための要求事項\u003C/strong>に焦点を当てている\u003C/li>\u003Cli>継続的改善よりも\u003Cstrong>規制要求事項への適合\u003C/strong>と品質システムの有効性維持を重視\u003C/li>\u003Cli>医療機器固有の要求事項（滅菌、クリーンルーム、トレーサビリティなど）を規定\u003C/li>\u003Cli>顧客満足に加えて、\u003Cstrong>患者安全\u003C/strong>を最優先事項としている\u003C/li>\u003C/ul>\u003Cp>これらの違いを理解することは、ISO9001認証を取得している企業がISO13485に対応する際に特に重要です。\u003C/p>\u003Ch2 id=\"hb1c8abcb7c\">\u003Cstrong>ISO13485:2016の要求事項の概要\u003C/strong>\u003C/h2>\u003Cp>ISO13485:2016は、医療機器の品質マネジメントシステムに関する包括的な要求事項を規定しています。以下、主要な章ごとの要点を解説します。\u003C/p>\u003Cp>\u003Cstrong>4章：品質マネジメントシステム\u003C/strong>\u003C/p>\u003Cp>この章では、QMSの基本的な要求事項を規定しています：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>4.1 一般要求事項\u003C/strong>: QMSの確立、文書化、実施、維持および有効性確保\u003C/li>\u003Cli>\u003Cstrong>4.2 文書化に関する要求事項\u003C/strong>: 品質方針・目標、品質マニュアル、手順の文書化、記録などの管理\u003C/li>\u003C/ul>\u003Cp>特に重要なのは「\u003Cstrong>医療機器ファイル（製品標準書）\u003C/strong>」の要求事項（4.2.3項）で、各医療機器の型式または医療機器ファミリごとに、規制適合性を証明するためのファイルを作成・維持することが求められます。\u003C/p>\u003Cp>\u003Cstrong>5章：経営者の責任\u003C/strong>\u003C/p>\u003Cp>経営者のコミットメントと責任を規定する章です：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>5.1 経営者のコミットメント\u003C/strong>: QMS確立と有効性維持への責任を明示\u003C/li>\u003Cli>\u003Cstrong>5.3 品質方針\u003C/strong>: 組織の目的に適合した品質方針の設定\u003C/li>\u003Cli>\u003Cstrong>5.5 責任、権限、コミュニケーション\u003C/strong>: 組織内の責任体制の明確化\u003C/li>\u003Cli>\u003Cstrong>5.6 マネジメントレビュー\u003C/strong>: QMSの適切性、妥当性、有効性の経営者による定期的な見直し\u003C/li>\u003C/ul>\u003Cp>特に、\u003Cstrong>マネジメントレビューのインプット\u003C/strong>（5.6.2項）には、規制当局への報告や適用される新規・改正規制要求事項への対応など、医療機器特有の項目が含まれています。\u003C/p>\u003Cp>\u003Cstrong>6章：資源の運用管理\u003C/strong>\u003C/p>\u003Cp>この章では、QMSの実施と維持に必要な資源について規定しています：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>6.2 人的資源\u003C/strong>: 力量、認識、教育訓練に関する要求事項\u003C/li>\u003Cli>\u003Cstrong>6.3 インフラストラクチャ\u003C/strong>: 建物、作業空間、設備、支援サービスなど\u003C/li>\u003Cli>\u003Cstrong>6.4 作業環境と汚染管理\u003C/strong>: 製品品質を確保するための作業環境要件\u003C/li>\u003C/ul>\u003Cp>特に、6.4.2項の「\u003Cstrong>汚染管理\u003C/strong>」は2016年版で新設された要求事項で、製品の清浄性確保のための仕組みが求められています。\u003C/p>\u003Cp>\u003Cstrong>7章：製品実現\u003C/strong>\u003C/p>\u003Cp>製品実現に関する幅広い要求事項を規定する最も大きな章です：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>7.1 製品実現の計画\u003C/strong>: リスクマネジメントを含む製品実現計画\u003C/li>\u003Cli>\u003Cstrong>7.2 顧客関連のプロセス\u003C/strong>: 製品要求事項の明確化とレビュー\u003C/li>\u003Cli>\u003Cstrong>7.3 設計・開発\u003C/strong>: 設計計画から設計移管、変更管理まで\u003C/li>\u003Cli>\u003Cstrong>7.4 購買\u003C/strong>: 購買プロセス、購買情報、購買製品の検証\u003C/li>\u003Cli>\u003Cstrong>7.5 製造及びサービスの提供\u003C/strong>: 製造管理、保管、流通、市販後サービス、バリデーション、識別、トレーサビリティなど\u003C/li>\u003Cli>\u003Cstrong>7.6 監視機器及び測定機器の管理\u003C/strong>: 校正、保全、記録の要求事項\u003C/li>\u003C/ul>\u003Cp>医療機器固有の要求事項として、\u003Cstrong>設計移管\u003C/strong>（7.3.8項）、\u003Cstrong>滅菌工程のバリデーション\u003C/strong>（7.5.7項）、\u003Cstrong>植込医療機器の追跡可能性\u003C/strong>（7.5.9.2項）などがあります。\u003C/p>\u003Cp>\u003Cstrong>8章：測定、分析及び改善\u003C/strong>\u003C/p>\u003Cp>QMSとプロセスの有効性評価と改善に関する章です：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>8.2 監視及び測定\u003C/strong>: 製品の出荷判定、苦情処理、内部監査などの工程および製品の監視測定\u003C/li>\u003Cli>\u003Cstrong>8.3 不適合製品の管理\u003C/strong>: 不適合発見時の措置と記録、規制当局への報告\u003C/li>\u003Cli>\u003Cstrong>8.4 データの分析\u003C/strong>: QMSの適切性と有効性評価のためのデータ分析\u003C/li>\u003Cli>\u003Cstrong>8.5 改善\u003C/strong>: 是正処置、予防処置に関する要求事項\u003C/li>\u003C/ul>\u003Cp>特に、\u003Cstrong>苦情処理\u003C/strong>（8.2.2項）と\u003Cstrong>規制当局への報告\u003C/strong>（8.2.3項）は2016年版で新設された医療機器特有の要求事項です。\u003C/p>\u003Ch2 id=\"hfc6878a073\">\u003Cstrong>ISO13485導入の実践的ステップ\u003C/strong>\u003C/h2>\u003Cp>ISO13485の導入は単なる認証取得が目的ではなく、品質システムの確立・改善を通じて、安全で有効な医療機器を提供することが本質的な目的です。以下に、実践的な導入ステップを示します。\u003C/p>\u003Ch3 id=\"h487d11b703\">\u003Cstrong>導入準備フェーズ\u003C/strong>\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>現状分析\u003C/strong>:\u003Cul>\u003Cli>既存の品質システムの状況を評価（ギャップ分析）\u003C/li>\u003Cli>適用される規制要求事項の特定\u003C/li>\u003Cli>組織のリソースと制約の分析\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>導入計画立案\u003C/strong>:\u003Cul>\u003Cli>プロジェクトチームの編成（経営層の参画が重要）\u003C/li>\u003Cli>スコープ、目標、タイムライン、責任者の設定\u003C/li>\u003Cli>必要なリソースの確保\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>教育訓練の実施\u003C/strong>:\u003Cul>\u003Cli>経営層向けの概要研修\u003C/li>\u003Cli>実務担当者向けの詳細研修\u003C/li>\u003Cli>内部監査員の養成\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h751dd60fab\">\u003Cstrong>QMS構築フェーズ\u003C/strong>\u003C/h3>\u003Col start=\"4\">\u003Cli>\u003Cstrong>文書体系の構築\u003C/strong>:\u003Cul>\u003Cli>QMSマニュアルの作成\u003C/li>\u003Cli>手順書・標準作業手順書（SOP）の整備\u003C/li>\u003Cli>記録様式の設計\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>プロセスの確立\u003C/strong>:\u003Cul>\u003Cli>ISO13485の要求事項に基づくプロセスの設計・見直し\u003C/li>\u003Cli>プロセス間の相互関係の明確化\u003C/li>\u003Cli>リスクアプローチの導入\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>パイロット運用\u003C/strong>:\u003Cul>\u003Cli>主要プロセスの試験的実施\u003C/li>\u003Cli>初期の問題点の識別と修正\u003C/li>\u003Cli>実務レベルでの調整\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h5b07964952\">\u003Cstrong>運用・評価フェーズ\u003C/strong>\u003C/h3>\u003Col start=\"7\">\u003Cli>\u003Cstrong>全面運用開始\u003C/strong>:\u003Cul>\u003Cli>全プロセスの本格実施\u003C/li>\u003Cli>記録の作成と維持\u003C/li>\u003Cli>パフォーマンス測定の開始\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>内部監査の実施\u003C/strong>:\u003Cul>\u003Cli>監査計画の策定\u003C/li>\u003Cli>監査チームによる監査実施\u003C/li>\u003Cli>不適合事項の特定と是正処置の実施\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>マネジメントレビュー実施\u003C/strong>:\u003Cul>\u003Cli>QMSの適切性、妥当性、有効性の評価\u003C/li>\u003Cli>改善の機会の特定\u003C/li>\u003Cli>リソース配分の見直し\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"hb1298efa02\">\u003Cstrong>認証取得フェーズ\u003C/strong>\u003C/h3>\u003Col start=\"10\">\u003Cli>\u003Cstrong>認証審査の準備\u003C/strong>:\u003Cul>\u003Cli>認証機関の選定\u003C/li>\u003Cli>申請書類の準備\u003C/li>\u003Cli>予備審査（オプション）\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>本審査対応\u003C/strong>:\u003Cul>\u003Cli>第1段階審査（文書審査）\u003C/li>\u003Cli>第2段階審査（実地審査）\u003C/li>\u003Cli>指摘事項への対応\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>認証取得後の運用\u003C/strong>:\u003Cul>\u003Cli>定期的なサーベイランス審査への対応\u003C/li>\u003Cli>継続的な改善活動\u003C/li>\u003Cli>規制要求事項の変更への対応\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h2f11bfd019\">\u003Cstrong>ISO13485導入のチェックリスト\u003C/strong>\u003C/h3>\u003Cp>以下は、ISO13485導入の各段階で確認すべき主要項目です：\u003C/p>\u003Cp>□ 経営層のコミットメントが確保されている\u003Cbr>□ QMS導入の目的と範囲が明確に定義されている\u003Cbr>□ 適用される規制要求事項が特定されている\u003Cbr>□ 責任者の責任と権限が明確に定義されている\u003Cbr>□ 責任者と主な担当者が任命されている\u003Cbr>□ 必要なリソースが配分されている\u003Cbr>□ 現状分析（ギャップ分析）が完了している\u003Cbr>□ 品質方針と品質目標が設定されている\u003Cbr>□ QMS文書体系が確立されている\u003Cbr>□ 主要プロセスが特定され、相互関係が明確化されている\u003Cbr>□ リスクマネジメントプロセスが統合されている\u003Cbr>□ 教育訓練プログラムが実施されている\u003Cbr>□ 内部監査プログラムが確立されている\u003Cbr>□ マネジメントレビューが計画されている\u003Cbr>□ 記録管理システムが確立されている\u003Cbr>□ 認証審査のための準備が整っている\u003C/p>\u003Ch2 id=\"hf3e4ab808e\">\u003Cstrong>ISO13485実装における課題と解決策\u003C/strong>\u003C/h2>\u003Cp>ISO13485の導入・運用において、多くの医療機器メーカーが直面する典型的な課題とその解決策を解説します。\u003C/p>\u003Ch3 id=\"h4447936d65\">\u003Cstrong>日本企業が直面する典型的な課題\u003C/strong>\u003C/h3>\u003Cp>\u003Cstrong>1. 規格要求事項の解釈\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: ISO13485の要求事項は抽象的な記述が多く、具体的にどのように実装すればよいか迷うケースが多い。\u003C/p>\u003Cp>\u003Cstrong>解決策\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>認証機関や専門コンサルタントへの相談\u003C/li>\u003Cli>業界団体が提供するガイダンスの活用（医機連や日本QA研究会の資料など）\u003C/li>\u003Cli>研修・セミナーへの参加による実践的な知識の習得\u003C/li>\u003Cli>先行企業のベストプラクティスの参照（公開事例や交流会など）\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>2. QMS省令との二重管理\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: 日本では、ISO13485とQMS省令の両方への対応が必要となり、文書や記録の二重管理が発生することがある。特に医療機器製造販売後安全管理、販売・貸与業、修理業へのQMS適用など製造販売業、製造業以外の医療機器関連業務へのQMS対応\u003C/p>\u003Cp>\u003Cstrong>解決策\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>ISO13485とQMS省令の適用範囲と要求事項のマッピングを行い、共通点と相違点を明確化\u003C/li>\u003Cli>QMS文書を設計する際に、両方の要求事項を満たすよう統合的に設計\u003C/li>\u003Cli>QMS省令「第2章から第5章まで（基本的要求事項）」はISO13485とほぼ整合しているため、こちらを基盤として構築\u003C/li>\u003Cli>QMS省令「第6章（医療機器製造業者等への準用）」、薬機法、安全管理基準など日本固有の要求事項を追加対応\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>3. リスクアプローチの実践\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: ISO13485:2016ではQMSのあらゆる側面でリスクアプローチが求められるが、どの程度まで実施すべきか判断が難しい。\u003C/p>\u003Cp>\u003Cstrong>解決策\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>ISO14971（医療機器のリスクマネジメント）との統合的アプローチの採用\u003C/li>\u003Cli>QMS各プロセスのリスク評価手法の確立（FTA、FMEA、HACCP等の手法の活用）\u003C/li>\u003Cli>リスクレベルに応じた管理の程度の設定（リスクマトリクスの活用）\u003C/li>\u003Cli>リスク管理レビューをマネジメントレビューのインプットに含める\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>4. サプライヤー管理の強化\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: 2016年版では外部委託プロセスと購買管理の要求が強化されたが、特に中小企業ではサプライヤーに対する影響力が限られる。\u003C/p>\u003Cp>\u003Cstrong>解決策\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>サプライヤーのクラス分け（製品品質への影響度に応じた管理レベルの設定）\u003C/li>\u003Cli>品質契約書の締結による役割と責任の明確化\u003C/li>\u003Cli>定期的な監査やアセスメントの実施（重要なサプライヤーに対して）\u003C/li>\u003Cli>共同教育プログラムや技術支援の提供、定期的なコミュニケーションによるパートナーシップ構築\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>5. 変更管理の適切な実施\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: 製品や工程の変更が頻繁に発生する中、変更の影響評価とバリデーションの範囲設定が難しい。\u003C/p>\u003Cp>\u003Cstrong>解決策\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>リスク分析による変更の分類基準の確立（大・中・小変更などのカテゴリ分け）\u003C/li>\u003Cli>変更の影響範囲を評価するためのチェックリストの活用\u003C/li>\u003Cli>変更管理委員会などの横断的な評価体制の確立\u003C/li>\u003Cli>変更履歴とその影響評価の記録の体系的な管理\u003C/li>\u003C/ul>\u003Ch3 id=\"he4511b5f74\">\u003Cstrong>実装のための実践的アドバイス\u003C/strong>\u003C/h3>\u003Cp>\u003Cstrong>文書・記録管理の効率化\u003C/strong>\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>電子文書管理システム（EDMS）の活用\u003C/strong>: 承認フローの自動化や文書のバージョン管理の効率化\u003C/li>\u003Cli>\u003Cstrong>マスター文書リスト（MDL）の整備\u003C/strong>: 文書体系の全体像を把握し、最新版管理を容易にする\u003C/li>\u003Cli>\u003Cstrong>記録の保管期間と保管方法の明確化\u003C/strong>: 医療機器のリスククラスや製品寿命に応じた適切な設定\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>バリデーションの効率的アプローチ\u003C/strong>\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>バリデーションマスタープランの策定\u003C/strong>: 製品/プロセス全体のバリデーション戦略を明確にする\u003C/li>\u003Cli>\u003Cstrong>リスクベースでのバリデーション範囲設定\u003C/strong>: 製品安全性への影響度に応じたバリデーション範囲の最適化\u003C/li>\u003Cli>\u003Cstrong>再バリデーション基準の明確化\u003C/strong>: 変更時の再バリデーション要否を判断する基準の確立\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>内部監査の実効性向上\u003C/strong>\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>プロセスベースの監査アプローチ\u003C/strong>: 部門別ではなくプロセスの流れに沿った監査の実施\u003C/li>\u003Cli>\u003Cstrong>リスクベースの監査計画\u003C/strong>: 過去の不適合傾向やプロセスの重要度に基づく監査頻度と深さの設定\u003C/li>\u003Cli>\u003Cstrong>クロス監査の実施\u003C/strong>: 監査の独立性確保と組織内知識共有のための部門間相互監査\u003C/li>\u003C/ul>\u003Ch2 id=\"hd22483fa4b\">\u003Cstrong>審査・査察対応のポイント\u003C/strong>\u003C/h2>\u003Cp>ISO13485の認証審査や規制当局による査察は、QMSの適合性と有効性を評価する重要な機会です。ここでは、審査・査察を成功させるためのポイントを解説します。\u003C/p>\u003Ch3 id=\"h46ba72daad\">\u003Cstrong>ISO13485認証審査への対応\u003C/strong>\u003C/h3>\u003Cp>\u003Cstrong>審査準備のポイント\u003C/strong>\u003C/p>\u003Col>\u003Cli>\u003Cstrong>事前の文書レビュー\u003C/strong>:\u003Cul>\u003Cli>品質マニュアル、手順書等の最新版管理の確認\u003C/li>\u003Cli>規格要求事項と文書のマッピングの実施\u003C/li>\u003Cli>過去の審査での指摘事項の是正状況の確認\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>記録の整備\u003C/strong>:\u003Cul>\u003Cli>必要な記録が作成・維持されていることの確認\u003C/li>\u003Cli>記録の検索性の確保\u003C/li>\u003Cli>トレーサビリティの確認（特に設計記録、製造記録など）\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>スタッフの準備\u003C/strong>:\u003Cul>\u003Cli>審査対応者への審査手順の説明\u003C/li>\u003Cli>想定質問と回答の準備（特に前回指摘事項関連）\u003C/li>\u003Cli>審査中の心構えと対応方法の教育\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>審査当日の対応ポイント\u003C/strong>\u003C/p>\u003Col>\u003Cli>\u003Cstrong>情報提供と透明性\u003C/strong>:\u003Cul>\u003Cli>質問に対する正確かつ簡潔な回答\u003C/li>\u003Cli>必要な記録・文書の迅速な提示\u003C/li>\u003Cli>問題点があれば隠さず説明（改善計画を含む）\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>審査の流れへの適応\u003C/strong>:\u003Cul>\u003Cli>審査計画の変更にも柔軟に対応\u003C/li>\u003Cli>審査員の関心領域を把握し適切に対応\u003C/li>\u003Cli>指摘事項の正確な理解と確認\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>良好な関係構築\u003C/strong>:\u003Cul>\u003Cli>審査員との建設的なコミュニケーション\u003C/li>\u003Cli>審査を学びの機会として活用する姿勢\u003C/li>\u003Cli>審査チームへの適切な対応（休憩、昼食等の配慮）\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>審査後のフォローアップ\u003C/strong>\u003C/p>\u003Col>\u003Cli>\u003Cstrong>指摘事項への対応\u003C/strong>:\u003Cul>\u003Cli>根本原因分析の徹底\u003C/li>\u003Cli>効果的な是正処置計画の立案\u003C/li>\u003Cli>水平展開の検討\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>継続的改善への活用\u003C/strong>:\u003Cul>\u003Cli>審査での気づきをQMS改善に活用\u003C/li>\u003Cli>好事例（グッドプラクティス）の組織内共有\u003C/li>\u003Cli>次回審査に向けた改善計画の策定\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"hccbdc496d5\">\u003Cstrong>QMS適合性調査への対応\u003C/strong>\u003C/h3>\u003Cp>PMDA（医薬品医療機器総合機構）もしくは第三者認証機関によるQMS適合性調査は、日本の医療機器メーカーにとって重要な規制対応です。ISO13485認証があっても、QMS省令への適合性確認のため調査が行われます。\u003C/p>\u003Cp>\u003Cstrong>QMS適合性調査の特徴と対応ポイント\u003C/strong>\u003C/p>\u003Col>\u003Cli>\u003Cstrong>QMS省令特有の要求事項への対応\u003C/strong>:\u003Cul>\u003Cli>医療機器等総括製造販売責任者の業務（第71条）\u003C/li>\u003Cli>国内品質業務運営責任者の業務（第72条）\u003C/li>\u003Cli>生物由来医療機器等の特別要求事項（第4章）\u003C/li>\u003Cli>これらの要求事項に関する文書・記録の整備\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>市販前・市販後の一貫した管理\u003C/strong>:\u003Cul>\u003Cli>製造販売後安全管理（GVP）との連携\u003C/li>\u003Cli>不具合情報の収集・分析・報告体制\u003C/li>\u003Cli>市販後のフィードバックシステムの有効性\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの確保\u003C/strong>:\u003Cul>\u003Cli>製品標準書から製造記録までの一貫性\u003C/li>\u003Cli>原材料から最終製品までの追跡可能性\u003C/li>\u003Cli>変更履歴の明確な記録\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>よくある指摘事項と対策\u003C/strong>\u003C/p>\u003Col>\u003Cli>\u003Cstrong>文書・記録の不備\u003C/strong>:\u003Cul>\u003Cli>QMS文書体系の整合性確保（上位文書と下位文書の一貫性）\u003C/li>\u003Cli>記録様式の標準化と記入ルールの明確化\u003C/li>\u003Cli>記録のレビュー・承認プロセスの確実な実施\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>変更管理の不備\u003C/strong>:\u003Cul>\u003Cli>変更の影響評価の徹底（規制影響を含む）\u003C/li>\u003Cli>変更実施前の適切な承認の取得\u003C/li>\u003Cli>変更後の検証・バリデーションの確実な実施\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>是正・予防処置の不備\u003C/strong>:\u003Cul>\u003Cli>根本原因分析の徹底\u003C/li>\u003Cli>是正・予防処置の有効性評価の実施\u003C/li>\u003Cli>類似製品・工程への水平展開の検討\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>購買管理の不備\u003C/strong>:\u003Cul>\u003Cli>サプライヤー評価基準の明確化と適合性の定期確認\u003C/li>\u003Cli>購買製品の検証の適切な実施\u003C/li>\u003Cli>重要なサプライヤーに対する監査の実施\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの指摘事項を予防するためには、内部監査時にこれらの観点を含めたチェックを行い、事前に是正しておくことが効果的です。\u003C/p>\u003Ch2 id=\"h852a920f8b\">\u003Cstrong>ISO13485実装の成功事例と教訓\u003C/strong>\u003C/h2>\u003Cp>実際の医療機器メーカーにおけるISO13485実装の事例から得られた教訓と成功要因の実例を紹介します。\u003C/p>\u003Ch3 id=\"h1669ed0e64\">\u003Cstrong>中小医療機器メーカーの導入事例\u003C/strong>\u003C/h3>\u003Cp>\u003Cstrong>事例1: 段階的アプローチによる成功\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>企業概要\u003C/strong>: 従業員50名の整形外科用インプラント製造企業\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: 限られたリソースでISO13485とQMS省令への対応が必要だった\u003C/p>\u003Cp>\u003Cstrong>アプローチ\u003C/strong>:\u003C/p>\u003Col>\u003Cli>コアプロセスから取り組む段階的実装計画の策定\u003C/li>\u003Cli>製品実現（設計・製造）プロセスを最初に整備\u003C/li>\u003Cli>支援プロセス（購買、教育訓練等）を次に整備\u003C/li>\u003Cli>マネジメントプロセスを最後に整備\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>成功要因\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>経営層が先頭に立ち、全社的な取り組みとして推進\u003C/li>\u003Cli>各部門から選抜したQMSチームによる横断的活動\u003C/li>\u003Cli>外部コンサルタントの戦略的活用（コアプロセス構築時のみ）\u003C/li>\u003Cli>既存の業務プロセスを尊重したQMS構築（過剰な文書化を避ける）\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>効果\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>計画的な取り組みにより18ヶ月でISO13485認証取得\u003C/li>\u003Cli>QMS構築過程で業務効率化も実現\u003C/li>\u003Cli>欧州市場への輸出が可能になり、売上30%増加\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>事例2: 統合的QMSによる複数規格対応\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>企業概要\u003C/strong>: 従業員200名の診断機器メーカー\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: ISO9001、ISO13485、QMS省令、米国FDA QSRなど複数の基準への対応が必要\u003C/p>\u003Cp>\u003Cstrong>アプローチ\u003C/strong>:\u003C/p>\u003Col>\u003Cli>各規格要求事項の比較分析と統合マッピングの作成\u003C/li>\u003Cli>最も厳しい要求事項を採用した統合QMSの構築\u003C/li>\u003Cli>国・地域別の固有要求事項に対応するための補足手順の作成\u003C/li>\u003Cli>文書管理システムによる効率的な文書・記録管理の実現\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>成功要因\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>プロセスマップを活用した組織全体の業務フローの可視化\u003C/li>\u003Cli>リスク分析に基づく重点管理ポイントの特定\u003C/li>\u003Cli>電子文書管理システムの導入による管理効率化\u003C/li>\u003Cli>定期的な内部監査による継続的な改善サイクルの確立\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>効果\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>複数の認証・承認を効率的に取得・維持\u003C/li>\u003Cli>文書作成・管理工数の40%削減\u003C/li>\u003Cli>グローバル展開の加速（5カ国での製品登録円滑化）\u003C/li>\u003C/ul>\u003Ch3 id=\"h9369b65ec6\">\u003Cstrong>大手医療機器メーカーの改善事例\u003C/strong>\u003C/h3>\u003Cp>\u003Cstrong>事例3: リスクアプローチの強化\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>企業概要\u003C/strong>: 従業員1000名超の総合医療機器メーカー\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: ISO13485:2016への移行におけるリスクアプローチの強化が必要\u003C/p>\u003Cp>\u003Cstrong>アプローチ\u003C/strong>:\u003C/p>\u003Col>\u003Cli>ISO14971、IEC62366-1（ユーザビリティエンジニアリング）とISO13485のリスク概念の整理と統合\u003C/li>\u003Cli>QMSの各プロセスにリスク評価を統合（FTA、FMEA手法を活用）\u003C/li>\u003Cli>リスクレベルに応じた管理水準の設定（3段階のリスクカテゴリ）\u003C/li>\u003Cli>リスク情報の定期的レビュー体制の確立\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>成功要因\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>リスク管理専門チームの設置と全社教育の実施\u003C/li>\u003Cli>製品リスク・プロセスリスク・ビジネスリスクの統合的管理\u003C/li>\u003Cli>IT技術を活用したリスク情報のリアルタイム共有\u003C/li>\u003Cli>市販後情報のリスク評価へのフィードバック体制の確立\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>効果\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>重大なリスクに対する先手の対策が可能に\u003C/li>\u003Cli>変更管理の効率化（リスクに基づく優先順位付け）\u003C/li>\u003Cli>品質問題の20%削減とリコール防止\u003C/li>\u003Cli>規制当局調査での高評価獲得\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>事例4: サプライヤー管理の改革\u003C/strong>\u003C/p>\u003Cp>\u003Cstrong>企業概要\u003C/strong>: グローバル展開する植込型医療機器メーカー\u003C/p>\u003Cp>\u003Cstrong>課題\u003C/strong>: 複雑なサプライチェーンにおける品質問題の発生\u003C/p>\u003Cp>\u003Cstrong>アプローチ\u003C/strong>:\u003C/p>\u003Col>\u003Cli>サプライヤーのリスク分類とそれに基づく管理レベルの設定\u003C/li>\u003Cli>重要サプライヤーとの品質契約の再構築\u003C/li>\u003Cli>パフォーマンス指標（KPI）に基づくサプライヤー評価システムの導入\u003C/li>\u003Cli>サプライヤー品質改善プログラムの実施\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>成功要因\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>サプライヤーとの協働アプローチ（対立でなくパートナーシップ）\u003C/li>\u003Cli>明確な期待事項と評価基準の提示\u003C/li>\u003Cli>サプライヤーへの技術支援と教育の提供\u003C/li>\u003Cli>定期的なコミュニケーションと情報共有の場の設定\u003C/li>\u003C/ul>\u003Cp>\u003Cstrong>効果\u003C/strong>:\u003C/p>\u003Cul>\u003Cli>購買品質問題の35%減少\u003C/li>\u003Cli>サプライヤー監査の効率化（リスクアプローチにより）\u003C/li>\u003Cli>重要部品の納期遵守率の向上\u003C/li>\u003Cli>総所有コスト（TCO）の削減\u003C/li>\u003C/ul>\u003Ch2 id=\"h0862208e64\">\u003Cstrong>今後の展望とまとめ\u003C/strong>\u003C/h2>\u003Cp>\u003Cstrong>ISO13485の今後の動向\u003C/strong>\u003C/p>\u003Cp>ISO13485は医療機器の品質管理における国際的な基準として定着していますが、技術進歩や規制環境の変化に伴い、今後も進化していくと考えられます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>次期改訂の方向性\u003C/strong>:\u003Cul>\u003Cli>ISO/TC 210（医療機器の品質管理）では定期的に規格のレビューを実施\u003C/li>\u003Cli>次期改訂では、ISO9001:2015で採用された高水準構造（HLS）の採用可能性\u003C/li>\u003Cli>ソフトウェア医療機器（SaMD）や人工知能（AI）技術への対応強化\u003C/li>\u003Cli>サイバーセキュリティ要求事項の拡充\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>国際的な規制調和の進展\u003C/strong>:\u003Cul>\u003Cli>MDSAP（医療機器単一監査プログラム）の拡大と普及\u003C/li>\u003Cli>EUのMDR/IVDRとの整合性強化\u003C/li>\u003Cli>グローバルな医療機器UDI（機器固有識別）システムとの連携\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>デジタル化・自動化の進展\u003C/strong>:\u003Cul>\u003Cli>電子QMS（eQMS）の普及と規制対応\u003C/li>\u003Cli>リアルタイムデータ分析と品質予測の活用\u003C/li>\u003Cli>ブロックチェーン技術を活用したトレーサビリティシステムの発展\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>\u003Cstrong>まとめ：ISO13485の本質を理解する\u003C/strong>\u003C/p>\u003Cp>ISO13485は単なる規格要求事項のチェックリストではなく、医療機器の安全性と有効性を確保するための体系的なアプローチを提供するものです。その本質的な価値は以下の点にあります：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者安全の確保\u003C/strong>: 最終的には患者の安全を確保するための仕組みであることを常に意識する\u003C/li>\u003Cli>\u003Cstrong>リスクベースの意思決定\u003C/strong>: 製品やプロセスのリスクに応じた管理方法の選択と資源配分\u003C/li>\u003Cli>\u003Cstrong>プロセスアプローチ\u003C/strong>: 組織活動を相互に関連するプロセスとして捉え、全体最適を図る\u003C/li>\u003Cli>\u003Cstrong>継続的な改善\u003C/strong>: 市場からのフィードバックを活用した製品とQMSの継続的な改善\u003C/li>\u003Cli>\u003Cstrong>規制適合性の確保\u003C/strong>: 変化する規制環境に柔軟に対応できる品質システムの構築\u003C/li>\u003C/ol>\u003Cp>医療機器メーカーには、ISO13485の形式的な遵守にとどまらず、その本質を理解し、自社の事業特性に合わせた効果的なQMSを構築・運用することが求められます。それが結果として、安全で有効な医療機器を通じた社会貢献と、持続的な企業価値の向上につながるでしょう。\u003C/p>",{"url":94,"height":95,"width":96},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/bbdd6a18ca70496797c28843e6454ee1/iso-min.webp",358,558,"ISO13485の基本から実装までを解説。国際品質規格の要求事項、QMS省令との関係、認証取得手順、導入事例を網羅。効率的な品質マネジメントシステム構築で製品安全性と市場競争力を向上させる方法を学べます。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":99,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[101,105],{"id":102,"createdAt":103,"updatedAt":103,"publishedAt":103,"revisedAt":103,"name":104},"8iibkq3gyr","2024-05-31T02:25:20.559Z","ISO13485",{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":107,"createdAt":108,"updatedAt":109,"publishedAt":110,"revisedAt":109,"title":111,"content":112,"eyecatch":113,"description":117,"reviewer":118,"category":120},"qms-risk-management","2024-05-31T01:52:06.999Z","2024-10-22T06:20:50.157Z","2024-05-31T01:52:53.442Z","QMSのリスクマネジメントとは？","\u003Ch2 id=\"h9836546c1b\">QMSにおけるリスクマネジメントとは？\u003C/h2>\u003Ch3 id=\"h286faa8665\">具体的な定義\u003C/h3>\u003Cp>QMS（Quality Management System：品質管理監督システム）におけるリスクマネジメントとは、\u003Cstrong>医療機器の設計、製造、出荷、そして使用に関連するリスクを特定し、評価し、管理するプロセスのことを指します。\u003C/strong>これは、製品の品質と安全性を確保するための重要な要素であり、患者の安全を最優先に考えた体系的なアプローチです。\u003C/p>\u003Cp>リスクマネジメントは、医療機器の開発から市販後の監視に至るまで、製品のライフサイクル全体を通じて実施されます。具体的には、\u003Cstrong>潜在的な危害を特定し、そのリスクを評価し、必要に応じてリスク軽減措置を講じ、残存リスクを継続的にモニタリングする一連のプロセス\u003C/strong>を含みます。\u003C/p>\u003Ch3 id=\"he2485005d0\">目的\u003C/h3>\u003Cp>QMSにおけるリスクマネジメントの主な目的は、\u003Cstrong>医療機器の使用に関連する潜在的な危害を最小限に抑え、患者と医療従事者の安全を確保する\u003C/strong>ことです。同時に、医療機器の有効性と性能を最適化し、規制要件への適合を確実にすることも重要な目的となります。\u003C/p>\u003Cp>主な目的は以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者の安全性向上：\u003C/strong>医療機器の使用に伴うリスクを最小限に抑え、患者の安全を確保する\u003C/li>\u003Cli>\u003Cstrong>製品品質の向上：\u003C/strong>リスクを事前に特定し対策を講じることで、製品の品質と信頼性を高める\u003C/li>\u003Cli>\u003Cstrong>法規制への準拠：\u003C/strong>医療機器に関する各国の法規制や国際規格の要求事項に適合する\u003C/li>\u003Cli>\u003Cstrong>企業の信頼性向上：\u003C/strong>リスクマネジメントの実践により、企業の社会的責任を果たし、信頼性を高める\u003C/li>\u003Cli>\u003Cstrong>コスト削減：\u003C/strong>問題の早期発見・対策により、市場での製品回収や訴訟などのコストを削減する\u003C/li>\u003C/ol>\u003Cp>QMSにおけるリスクマネジメントは、単なる規制要件の遵守ではなく、医療機器の安全性と有効性を確保するための不可欠なプロセスとして位置づけられています。\u003C/p>\u003Ch2 id=\"h65b2240dc9\">QMSにおけるリスクマネジメントの必要性\u003C/h2>\u003Ch3 id=\"h4a784b5a9d\">なぜ必要なのか？\u003C/h3>\u003Cp>QMSにおけるリスクマネジメントが必要な理由は多岐にわたります。第一に、医療機器は繰り返し使用する機械物や使用方法が複雑な機器が多く、その性能、使用性は生命や健康に直接影響を与える製品であるため、その安全性と有効性の確保は極めて重要です。\u003C/p>\u003Cp>リスクマネジメントを通じて、製品の設計段階から使用段階に至るまでの潜在的なリスクを特定し、評価し、適切に管理することで、患者や使用者の安全を確保することができます。\u003C/p>\u003Cp>また、医療技術の進歩に伴い、医療機器はますます複雑化しています。この複雑性は新たなリスクを生み出す可能性があり、それらを適切に管理するためにもリスクマネジメントは不可欠です。さらに、グローバル化が進む医療機器市場において、各国の規制要件に適合するためにも、統一されたリスクマネジメントのアプローチが必要とされています。\u003C/p>\u003Ch3 id=\"had4a1e1a63\">対象となる活動や範囲\u003C/h3>\u003Cp>QMSにおけるリスクマネジメントは、医療機器のライフサイクル全体をカバーする広範な活動を対象としています。具体的には以下のような範囲が含まれます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>設計開発段階：\u003C/strong>\u003Cul>\u003Cli>設計開発初期段階のリスク分析\u003C/li>\u003Cli>設計検証・妥当性確認におけるリスク評価\u003C/li>\u003Cli>仕様変更時のリスク評価\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>製造段階：\u003C/strong>\u003Cul>\u003Cli>製造プロセス稼働性評価時のリスク分析\u003C/li>\u003Cli>製造工程変更時のリスク分析\u003C/li>\u003Cli>品質管理における統計的手法の適用\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>市販後段階：\u003C/strong>\u003Cul>\u003Cli>市販後監視（PMS）でのリスク情報の収集と分析\u003C/li>\u003Cli>是正措置・予防措置（CAPA）におけるリスク評価\u003C/li>\u003Cli>想定外使用による新たなリスクの発生\u003C/li>\u003Cli>サイバー攻撃によるセキュリティの脆弱性評価\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>サプライチェーン管理：\u003C/strong>\u003Cul>\u003Cli>サプライヤーのリスク評価\u003C/li>\u003Cli>原材料や部品の品質リスク管理\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>臨床評価：\u003C/strong>\u003Cul>\u003Cli>臨床試験におけるリスク評価\u003C/li>\u003Cli>市販後臨床フォローアップ（PMCF）でのリスクモニタリング\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの活動は相互に関連しており、一貫したリスクマネジメントアプローチを適用することが重要です。\u003C/p>\u003Ch3 id=\"hffbdb49730\">導入によるメリット\u003C/h3>\u003Cp>QMSにおけるリスクマネジメントを適切に導入することで、以下のようなメリットが得られます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者安全の向上：\u003C/strong> リスクを事前に特定し対策を講じることで、医療機器の使用に伴う危害を最小限に抑えることができます。これにより、患者の安全が向上し、医療の質の改善につながります。\u003C/li>\u003Cli>\u003Cstrong>製品品質の向上： \u003C/strong>設計段階からリスクを考慮することで、より安全で信頼性の高い製品を開発することができます。これは製品の品質向上につながり、市場での競争力を高めることができます。\u003C/li>\u003Cli>\u003Cstrong>規制要件への適合：\u003C/strong> 多くの国で医療機器のリスクマネジメントは法的要件となっています。適切なリスクマネジメントシステムを導入することで、各国の規制要件に効率的に対応することができます。\u003C/li>\u003Cli>\u003Cstrong>意思決定の改善：\u003C/strong> リスクベースの思考を導入することで、より客観的かつ合理的な意思決定が可能になります。これはQMSの運用を含め、製品開発から市販後の対応まであらゆる場面で有効です。\u003C/li>\u003Cli>\u003Cstrong>企業評判の保護：\u003C/strong> 安全性と品質に注力する企業としての評判は、顧客からの信頼獲得につながります。これは長期的な事業成功の鍵となります。\u003C/li>\u003Cli>\u003Cstrong>イノベーションの促進： \u003C/strong>リスクを適切に管理することで、新しい技術や設計の導入に伴うリスクを最小限に抑えることができます。これにより、より革新的な製品開発が可能になります。\u003C/li>\u003Cli>\u003Cstrong>コスト削減：\u003C/strong> 事前にリスクを特定し対策を講じることで、QMSの資源管理、市販後の不具合対応や回収などのコストを削減できます。長期的には、企業の収益性向上につながります。\u003C/li>\u003Cli>\u003Cstrong>グローバル展開の容易化：\u003C/strong> 国際的に認知されたリスクマネジメント手法を採用することで、グローバル市場への製品導入がスムーズになります。\u003C/li>\u003C/ol>\u003Cp>これらのメリットは、単に規制要件を満たすだけでなく、企業の競争力強化と持続可能な成長に大きく貢献します。\u003C/p>\u003Ch2 id=\"hf1be3caeab\">QMSにおけるリスクマネジメントの具体例\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Ch3 id=\"h78dc91797c\">医療機器業界における成功事例\u003C/h3>\u003Cp>ある人工関節メーカーの事例を紹介します。この企業は新しい人工股関節の開発において、QMSにおけるリスクマネジメントを効果的に適用し、大きな成功を収めました。\u003C/p>\u003Cp>開発の初期段階で、設計チームは包括的なリスク分析を実施しました。これには、従来の人工股関節で報告されていた不具合や、新しい設計に特有の潜在的リスクの特定が含まれていました。特に注目したのは、長期使用時の摩耗と、それに伴う金属イオンの放出リスクでした。\u003C/p>\u003Cp>この金属イオンが体内で放出されると、患者に重大な有害事象を引き起こすことが考えられました。\u003C/p>\u003Cp>このリスクアセスメントに基づき、以下の対策を講じました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>材料選択：\u003C/strong>従来のチタン合金に代わり、摩耗耐性に優れたセラミック複合材料を採用しました。\u003C/li>\u003Cli>\u003Cstrong>設計最適化：\u003C/strong>有限要素法を用いたコンピューターシミュレーションにより、応力分布を最適化し、摩耗のリスクを最小限に抑える形状を設計しました。\u003C/li>\u003Cli>\u003Cstrong>製造プロセス：\u003C/strong>より精密な加工技術を導入し、表面粗さを極限まで低減しました。\u003C/li>\u003Cli>\u003Cstrong>試験プロトコル：\u003C/strong>通常の耐久性試験に加え、極端な使用条件下での長期摩耗試験を実施しました。\u003C/li>\u003Cli>\u003Cstrong>市販後監視計画：\u003C/strong>詳細な追跡調査を行うため、患者登録システムを構築しました。\u003C/li>\u003C/ol>\u003Cp>これらの対策により、新しい人工股関節は従来製品と比較して、摩耗率を80%低減し、金属イオン放出をほぼゼロにすることに成功しました。市販後5年間の追跡調査では、重大な有害事象の報告はゼロでした。\u003C/p>\u003Cp>この成功は、開発初期段階からのリスクマネジメントの徹底的な適用によるものです。潜在的なリスクを早期に特定し、設計、材料選択、製造プロセス、そして市販後監視に至るまで一貫した対策を講じたことが、製品の安全性と性能の大幅な向上につながりました。\u003C/p>\u003Ch3 id=\"h6f8845176c\">医療機器業界における失敗事例\u003C/h3>\u003Cp>次に、ある血糖測定器メーカーの失敗事例を見てみましょう。この企業は新型の血糖測定器を開発する際に、QMSにおけるリスクマネジメントを適切に実施しなかったことで、深刻な問題に直面しました。\u003C/p>\u003Cp>開発チームは、測定速度と使いやすさを重視するあまり、以下のようなリスクマネジメントの不備がありました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>不十分なリスク分析：\u003C/strong>新しい測定アルゴリズムの潜在的な誤差要因について、十分な分析を行わなかった。\u003C/li>\u003Cli>\u003Cstrong>限定的な使用環境テスト：\u003C/strong>主に室温環境でのテストに焦点を当て、極端な温度条件下での性能評価を軽視した。\u003C/li>\u003Cli>\u003Cstrong>ユーザーエラーの過小評価：\u003C/strong>操作の簡便さを重視するあまり、誤使用のリスクを十分に考慮しなかった。\u003C/li>\u003Cli>\u003Cstrong>不十分な臨床評価：\u003C/strong>限られた患者群でのみ臨床試験を実施し、多様な患者背景での評価を怠った。\u003C/li>\u003Cli>\u003Cstrong>市販後監視の不備：\u003C/strong>問題報告の収集システムが不十分で、初期の警告信号を見逃した。\u003C/li>\u003C/ol>\u003Cp>製品発売後、以下のような深刻な問題が発生しました：\u003C/p>\u003Cul>\u003Cli>極端な高温・低温環境下で測定値が大きく変動し、誤った投薬につながる事例が報告された。\u003C/li>\u003Cli>操作手順が直感的すぎるとの理由で、重要な校正ステップを省略するユーザーが多く、測定精度に影響が出た。\u003C/li>\u003Cli>特定の薬剤を服用している患者で、一貫して高値を示す傾向が見られた。\u003C/li>\u003C/ul>\u003Cp>これらの問題により、多数の患者が不適切な糖尿病管理を行うこととなり、健康被害が報告されました。結果として、大規模なリコールを余儀なくされ、企業の評判は大きく損なわれました。\u003C/p>\u003Cp>この事例は、QMSにおけるリスクマネジメントの重要性を如実に示しています。適切なリスク分析と対策を講じていれば、これらの問題の多くは事前に予防または軽減できたはずです。特に、以下の点が重要でした：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>包括的なリスク分析：\u003C/strong>使用環境、ユーザー特性、干渉要因などを考慮した医療機器のライフサイクル全般に係る分析\u003C/li>\u003Cli>\u003Cstrong>厳密な検証・妥当性確認\u003C/strong>：想定できる極端な条件下での性能評価を含む、徹底的なテスト\u003C/li>\u003Cli>\u003Cstrong>使用性評価\u003C/strong>：合理的に予見可能な誤使用、使用エラーのリスクを考慮した設計と使用説明\u003C/li>\u003Cli>\u003Cstrong>広範な臨床評価：\u003C/strong>多様な患者群での評価\u003C/li>\u003Cli>\u003Cstrong>効果的な市販後監視：\u003C/strong>早期の問題検出と迅速な対応\u003C/li>\u003C/ul>\u003Cp>この失敗事例は、医療機器業界におけるリスクマネジメントの重要性を再認識させる教訓となりました。\u003C/p>\u003Ch2 id=\"h71ce50b488\">QMSにおけるリスクマネジメントの実施方法\u003C/h2>\u003Cp>QMSにおけるリスクマネジメントを効果的に実施するためには、体系的なアプローチが必要です。以下に、わかりやすい始め方ガイドを示します。\u003C/p>\u003Ch3 id=\"hd0638c6a4a\">ステップ1: リスクマネジメントチームの編成\u003C/h3>\u003Cp>まず、多様な専門知識を持つメンバーからなるリスクマネジメントチームを編成します。このチームには、設計エンジニア、品質保証担当者、規制対応専門家、臨床専門家、リスクマネジメント手法の専門家などを含めるべきです。チームの多様性は、様々な観点からリスクを特定し評価する上で重要です。\u003C/p>\u003Ch3 id=\"h141f5c1925\">ステップ2: リスクマネジメント計画の策定\u003C/h3>\u003Cp>リスクマネジメント活動の全体的な方針と手順を定めた計画書を作成します。この計画書には以下の要素を含めます：\u003C/p>\u003Cul>\u003Cli>リスクマネジメントの目的と範囲\u003C/li>\u003Cli>役割と責任の明確化\u003C/li>\u003Cli>リスク評価の基準（受容可能なリスクレベルの定義を含む）\u003C/li>\u003Cli>実施スケジュール\u003C/li>\u003Cli>残存リスクの評価方法\u003C/li>\u003Cli>必要なリソースの特定\u003C/li>\u003C/ul>\u003Ch3 id=\"h5fd461df41\">ステップ3: リスクの特定\u003C/h3>\u003Cp>製品要求事項、製品の特質をベースに、製品のライフサイクル全体を通じて潜在的なハザード（危害の潜在的な源）を特定します。以下の方法を活用します：\u003C/p>\u003Cul>\u003Cli>ブレインストーミング\u003C/li>\u003Cli>FMEA（故障モード影響解析）\u003C/li>\u003Cli>FTA（故障の木解析）\u003C/li>\u003Cli>過去の類似製品データの分析\u003C/li>\u003Cli>文献調査\u003C/li>\u003Cli>専門家の意見聴取\u003C/li>\u003Cli>ユーザビリティ評価結果\u003C/li>\u003C/ul>\u003Ch3 id=\"hfc0bc77a06\">ステップ4: リスクの分析\u003C/h3>\u003Cp>特定されたハザードに関する危険状態と危害を想定します。\u003C/p>\u003Cp>この段階では、以下の点に注意します：\u003C/p>\u003Cul>\u003Cli>FMEA（故障モード影響解析）、FTA（故障の木解析）などの分析を通じた客観的なデータに基づく分析\u003C/li>\u003Cli>不確実性の考慮\u003C/li>\u003Cli>異なる使用シナリオの検討\u003C/li>\u003C/ul>\u003Ch3 id=\"h5d09913ef7\">ステップ5: リスク評価\u003C/h3>\u003Cp>想定した危険状態と危害から、危害の発生確率と重大性を評価します。リスク評価マトリックスを使用して、各リスクの優先度を決定します。\u003C/p>\u003Ch3 id=\"hfce4cda81e\">ステップ6: リスクコントロールの実施\u003C/h3>\u003Cp>評価されたリスクに対して、以下の優先順位でリスクの低減策を検討・実施します：\u003C/p>\u003Col>\u003Cli>本質的安全設計\u003C/li>\u003Cli>防護手段\u003C/li>\u003Cli>安全上の情報提供\u003C/li>\u003C/ol>\u003Cp>各制御措置について、その有効性を検証し、新たなリスクを生じさせていないかを確認します。\u003C/p>\u003Ch3 id=\"hd4f005fb6e\">ステップ7: 残留リスクの評価\u003C/h3>\u003Cp>リスクコントロールを実施した後の残留リスクを評価し、それが許容可能なレベルにあるかを判断します。許容できない残留リスクがある場合は、さらなるリスクコントロールを検討します。\u003C/p>\u003Cp>ただし、医学的効果が残存リスクを上回ると判断できる場合（リスク・ベネフィット分析）は、更なるリスクコントロールを実施しないことができます。\u003C/p>\u003Ch3 id=\"hcb4864307d\">ステップ8: リスクマネジメント報告書の作成\u003C/h3>\u003Cp>リスクマネジメント活動の結果をまとめた報告書を作成します。この報告書には以下の内容を含めます：\u003C/p>\u003Cul>\u003Cli>特定されたハザード、危険状態と危害\u003C/li>\u003Cli>リスク評価の結果\u003C/li>\u003Cli>実施したリスクコントロールとその有効性\u003C/li>\u003Cli>残留リスクの評価結果\u003C/li>\u003Cli>リスク・ベネフィット分析の結果\u003C/li>\u003C/ul>\u003Ch3 id=\"hf404d62853\">ステップ9: 製造および製造後情報の収集と分析\u003C/h3>\u003Cp>市販後の情報を継続的に収集し、新たなリスクや予期せぬ問題が発生していないかを監視します。新たなリスクや予期せぬ問題が発生した場合は、リスクマネジメント計画を見直し、リスク評価結果を更新します。\u003C/p>\u003Ch2 id=\"h311ecc6296\">5. QMSにおけるリスクマネジメントの効果的な運用方法\u003C/h2>\u003Ch3 id=\"hb9e8ff209f\">モニタリングと評価方法\u003C/h3>\u003Cp>QMSにおけるリスクマネジメントを効果的に運用するためには、継続的なモニタリングと評価が不可欠です。以下に主要な方法を示します：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>定期的なリスクレビュー：\u003C/strong> 少なくとも年1回、または医療機器の仕様に大きな変更がある度に、特定されたリスクとリスクコントロールの有効性を見直します。新たな科学的知見や技術の進歩を考慮に入れ、リスク評価を更新します。\u003C/li>\u003Cli>\u003Cstrong>市販後監視（PMS）システムの活用： \u003C/strong>苦情、不具合報告、顧客フィードバックなどの情報を系統的に収集・分析し、新たなリスクや予期せぬ問題を早期に検出します。\u003C/li>\u003Cli>\u003Cstrong>トレンド分析：\u003C/strong> 収集したデータを時系列で分析し、リスクの傾向や潜在的な問題の兆候を特定します。統計的手法を用いて、有意な変化を検出します。\u003C/li>\u003Cli>\u003Cstrong>是正措置・予防措置（CAPA）システムとの連携：\u003C/strong> 特定された問題に対する是正措置や予防措置の有効性を評価し、リスクマネジメントプロセスにフィードバックします。\u003C/li>\u003Cli>\u003Cstrong>内部監査：\u003C/strong> リスクマネジメントプロセスの有効性を定期的に評価し、改善の機会を特定します。\u003C/li>\u003Cli>\u003Cstrong>パフォーマンス指標（KPI）の設定と監視： \u003C/strong>リスクマネジメントの有効性を測定するKPIを設定し、定期的に評価します。例えば、「特定されたリスクの数」「実施されたリスク低減措置の数」「残留リスクレベル」などが考えられます。\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">よくある課題とその対応方法\u003C/h3>\u003Cp>QMSにおけるリスクマネジメントの運用には、いくつかの一般的な課題があります。以下に主な課題とその対応方法を示します：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>リスク評価の主観性：\u003C/strong> 課題：リスクの評価が評価者の主観に左右されやすい。 対応：\u003Cul>\u003Cli>明確な評価基準を設定し、全ての評価者で共有する。\u003C/li>\u003Cli>評価基準の変更は、適切な承認手続きを踏む。\u003C/li>\u003Cli>複数の評価者による独立した評価を行い、結果を比較・議論する。\u003C/li>\u003Cli>可能な限り、客観的なデータや過去の事例を活用する。\u003C/li>\u003Cli>リスクマネジメント手法を習熟した専門家を養成する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>リソースの制約：\u003C/strong> 課題：リスクマネジメント活動に十分なリソース（時間、人員、予算）を割り当てることが難しい。 対応：\u003Cul>\u003Cli>リスクアプローチを採用し、高リスク領域に重点的にリソースを配分する。\u003C/li>\u003Cli>リスクマネジメント活動を既存のプロセス（例：設計レビュー）に統合し、効率化を図る。\u003C/li>\u003Cli>自動化ツールを活用し、データ収集や分析の効率を向上させる。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>組織全体の関与不足：\u003C/strong> 課題：リスクマネジメントが品質部門だけの責任と誤解されがちである。 対応：\u003Cul>\u003Cli>経営層のコミットメントを明確にし、リスクマネジメントの重要性を組織全体に伝達する。\u003C/li>\u003Cli>部門横断的なリスクマネジメントチームを編成し、多様な視点を取り入れる。\u003C/li>\u003Cli>リスクマネジメントに関する教育・訓練を全社的に実施する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>新技術や新たな用途に対するリスク評価の困難さ：\u003C/strong> 課題：革新的な技術や新しい適用分野では、過去のデータや経験が少なく、リスク評価が難しい。 対応：\u003Cul>\u003Cli>類似技術や関連分野の知見を積極的に活用する。\u003C/li>\u003Cli>早期のプロトタイピングやシミュレーションを活用し、リスクを探索的に評価する。\u003C/li>\u003Cli>専門家パネルを活用し、多角的な視点からリスクを検討する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>リスクコミュニケーションの課題： \u003C/strong>課題：特定されたリスクや残留リスクを適切に関係者（ユーザー、規制当局など）に伝達することが難しい。 対応：\u003Cul>\u003Cli>ターゲットオーディエンスに応じたコミュニケーション戦略を策定する。\u003C/li>\u003Cli>わかりやすい視覚的ツール（リスクマトリックスなど）を活用する。\u003C/li>\u003Cli>定期的なステークホルダーミーティングを開催し、リスク情報を共有・議論する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>リスクマネジメントの文書化の負担：\u003C/strong> 課題：リスクマネジメント活動の適切な文書化に多大な時間と労力がかかる。 対応：\u003Cul>\u003Cli>文書テンプレートの標準化と、可能な範囲での自動化を図る。\u003C/li>\u003Cli>リスクマネジメントソフトウェアを導入し、文書管理を効率化する。\u003C/li>\u003Cli>重要な決定事項と根拠に焦点を当てた簡潔な文書化を心がける。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの課題に適切に対応することで、QMSにおけるリスクマネジメントをより効果的に運用することができます。重要なのは、組織の状況に応じて柔軟にアプローチを調整し、継続的な改善を図ることです。\u003C/p>\u003Ch2 id=\"h51351c43d4\">6. まとめ\u003C/h2>\u003Cp>QMSにおけるリスクマネジメントは、\u003Cstrong>医療機器の安全性と有効性を確保するための不可欠な要素\u003C/strong>です。患者の安全を最優先に考え、製品のライフサイクル全体を通じて潜在的なリスクを特定、評価、管理するこのプロセスは、\u003Cstrong>単なる規制要件の遵守以上の価値\u003C/strong>をもたらします。\u003C/p>\u003Cp>効果的なリスクマネジメントの実践は、製品品質の向上、コスト削減、企業評判の保護など、多くのメリットをもたらします。しかし、その実施には様々な課題も存在します。リスク評価の客観性確保、リソースの適切な配分、組織全体の関与促進などの課題に対して、継続的な改善とイノベーションが求められます。\u003C/p>\u003Cp>最終的に、\u003Cstrong>QMSにおけるリスクマネジメントの成功は、それを組織文化の一部として根付かせ、日々の意思決定プロセスに組み込むことにかかっています。\u003C/strong>安全で効果的な医療機器を提供し、患者の生活の質を向上させるという使命を果たすため、リスクマネジメントの重要性を常に意識し、その実践に努めることが求められます。\u003C/p>",{"url":114,"height":115,"width":116},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/f161482e8cdb4016b06c96dd217b7cff/risk-min.webp",744,1182,"QMSにおけるリスクマネジメントの定義、目的、必要性を詳細に解説。医療機器の安全性と有効性確保への貢献を強調。設計から市販後監視まで製品ライフサイクル全体をカバーする包括的なプロセスとしての役割を明確化。成功・失敗事例を通じてその重要性を示し、効果的な実施方法と運用上の課題への対応策を提示。継続的改善の重要性を強調し、患者安全確保と企業の競争力強化に不可欠な戦略的ツールとしての価値を明示。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":119,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[121,126],{"id":122,"createdAt":123,"updatedAt":124,"publishedAt":123,"revisedAt":124,"name":125},"qjcr0mukw","2024-05-31T01:50:11.582Z","2024-09-17T04:29:11.954Z","リスクマネジメント",{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":128,"createdAt":129,"updatedAt":130,"publishedAt":131,"revisedAt":130,"title":132,"content":133,"eyecatch":134,"description":138,"reviewer":139,"category":141},"qms-internal-audit","2024-09-04T02:55:02.433Z","2025-04-24T02:35:04.661Z","2024-09-25T00:34:11.922Z","QMSの内部監査とは？","\u003Ch2 id=\"h1ff63644a7\">内部監査とは？\u003C/h2>\u003Cp>内部監査は、医療機器のQMS（品質管理監督システム）の重要な要素の一つです。この項目では、内部監査の具体的な定義と目的について解説します。\u003C/p>\u003Ch3 id=\"h286faa8665\">具体的な定義\u003C/h3>\u003Cp>QMSにおける内部監査とは、\u003Cstrong>組織が自ら実施する体系的、独立的、かつ文書化された評価プロセス\u003C/strong>のことを指します。この監査は、組織のQMSが効果的に機能しているかどうかを確認し、QMSの有効性の検証、改善の機会を特定するためあらかじめ定めた間隔で行われます。\u003C/p>\u003Cp>内部監査では、組織内の独立した立場にある担当者（内部監査員）が、QMSの各要素や活動を客観的、かつ公平に評価します。これには、\u003Cstrong>品質方針や品質目標の実施状態、手順書の遵守状況、製品の品質管理プロセス\u003C/strong>などが含まれます。\u003C/p>\u003Ch3 id=\"he2485005d0\">目的\u003C/h3>\u003Cp>QMSにおける内部監査の主な目的は以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>QMSの有効性評価\u003C/strong>：組織のQMSが適切に実施され、効果的に機能しているかを客観的、かつ公平に評価します。\u003C/li>\u003Cli>\u003Cstrong>法規制への適合性確認\u003C/strong>：医療機器に関する法規制や規格への適合性を確認します。\u003C/li>\u003Cli>\u003Cstrong>改善機会の特定\u003C/strong>：QMSの運用における問題点や改善の余地を特定し、継続的な改善につなげます。\u003C/li>\u003Cli>\u003Cstrong>リスク管理\u003C/strong>：潜在的なリスクを早期に発見し、予防措置を講じる機会を提供します。\u003C/li>\u003Cli>\u003Cstrong>経営層への情報提供：\u003C/strong>QMSの状態や課題について、経営層に客観的な情報を提供します。\u003C/li>\u003Cli>\u003Cstrong>品質文化の醸成\u003C/strong>：組織全体の品質意識を高め、品質重視の文化を育成します。\u003C/li>\u003C/ol>\u003Cp>内部監査は、単なる検査や問題点の指摘ではなく、組織の品質管理システムを継続的に改善し、製品の安全性と有効性を確保するための重要なツールとして機能します。\u003C/p>\u003Ch2 id=\"h65b5397ed7\">内部監査の必要性\u003C/h2>\u003Cp>QMSにおける内部監査は、医療機器産業において不可欠な要素です。この項目では、内部監査がなぜ必要なのか、どのような活動や範囲を対象とするのか、そして導入によるメリットについて詳しく説明します。\u003C/p>\u003Ch3 id=\"h4a784b5a9d\">なぜ必要なのか？\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>法規制の遵守：\u003C/strong> 医療機器産業は厳格な規制下にあります。例えば、日本では薬機法（医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律）、米国ではFDA（食品医薬品局）の規制、欧州ではMDR（Medical Device Regulation）などがあります。内部監査は、これらの法規制要件を確実に満たしていることを検証する重要な手段となります。\u003C/li>\u003Cli>\u003Cstrong>製品品質保証：\u003C/strong> 医療機器は人の生命や健康に直接関わるため、高い品質基準が求められます。内部監査を通じて、品質管理プロセスの有効性を継続的に評価し、製品の安全性と有効性を確保することができます。\u003C/li>\u003Cli>\u003Cstrong>リスク管理：\u003C/strong> 内部監査は、潜在的な問題や不適合を早期に発見し、是正するための機会を提供します。これにより、製品の不具合や市場からのリコールなど、重大なリスクを未然に防ぐことができます。\u003C/li>\u003Cli>\u003Cstrong>継続的改善：\u003C/strong> 内部監査は、QMSの弱点や改善の余地を特定するための有効な手段です。これにより、組織は常に品質管理システムを向上させ、効率性と有効性を高めることができます。\u003C/li>\u003Cli>\u003Cstrong>顧客信頼の獲得：\u003C/strong> 定期的な内部監査の実施は、組織の品質に対するコミットメントを示すものです。これは、顧客や規制当局からの信頼獲得につながります。\u003C/li>\u003C/ol>\u003Ch3 id=\"had4a1e1a63\">対象となる活動や範囲\u003C/h3>\u003Cp>QMSにおける内部監査の対象となる活動や範囲は広範囲に及びます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>組織のQMS全体：\u003C/strong>文書管理、記録管理、品質方針、品質目標、組織構造、責任と権限の割り当てなど。\u003C/li>\u003Cli>\u003Cstrong>製品実現プロセス\u003C/strong>：設計開発、購買管理、製造、保管、出荷、アフターサービスなど。\u003C/li>\u003Cli>\u003Cstrong>支援プロセス\u003C/strong>：教育訓練、施設・設備管理など。\u003C/li>\u003Cli>\u003Cstrong>測定・分析・改善プロセス\u003C/strong>：顧客からのフィードバック、内部監査、工程・製品品質の監視測定、不適合製品管理、データ分析、是正・予防措置など。\u003C/li>\u003Cli>\u003Cstrong>法規制要求事項への適合性\u003C/strong>：各国の医療機器規制への適合状況。\u003C/li>\u003C/ol>\u003Ch3 id=\"hffbdb49730\">導入によるメリット\u003C/h3>\u003Cp>QMSにおける内部監査の導入には、以下のようなメリットがあります：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>コンプライアンスの強化：\u003C/strong> 法規制要求事項への適合性を定期的に確認することで、コンプライアンス違反のリスクを低減できます。\u003C/li>\u003Cli>\u003Cstrong>品質の向上：\u003C/strong> 製品やプロセスの品質を継続的に評価し改善することで、全体的な品質レベルが向上します。\u003C/li>\u003Cli>\u003Cstrong>組織の透明性向上： \u003C/strong>内部監査結果を通じて、組織の現状や課題が明確になり、経営層の意思決定に役立ちます。\u003C/li>\u003Cli>\u003Cstrong>従業員の意識向上：\u003C/strong> 定期的な監査を通じて、従業員の品質意識や法規制に対する理解が深まります。\u003C/li>\u003Cli>\u003Cstrong>外部監査への準備：\u003C/strong> 内部監査を通じて問題点を事前に把握し改善することで、規制当局による査察や第三者認証機関の審査に効果的に対応できます。\u003C/li>\u003Cli>\u003Cstrong>競争力の強化：\u003C/strong> 高品質な製品と効率的なプロセスにより、市場での競争力が向上します。\u003C/li>\u003Cli>\u003Cstrong>リスク管理の強化：\u003C/strong> 潜在的なリスクを早期に特定し対処することで、製品の安全性が向上し、企業のレピュテーションリスクも軽減されます。\u003C/li>\u003Cli>\u003Cstrong>コスト削減： \u003C/strong>不適合や不具合を早期に発見し対処することで、後々の大きな問題や高額な是正コストを回避できます。\u003C/li>\u003C/ol>\u003Cp>これらのメリットにより、QMSにおける内部監査は単なる規制要件の遵守だけでなく、組織の継続的な成長と発展を支える重要な活動となります。\u003C/p>\u003Ch2 id=\"h15eaa6fd65\">内部監査の具体例\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Cp>QMSにおける内部監査の具体例として、成功事例と失敗事例をそれぞれ1つずつ詳しく解説します。これらの事例を通じて、内部監査の重要性と効果的な実施方法について理解を深めることができます。\u003C/p>\u003Ch3 id=\"h64ccfb3496\">成功事例：医療機器メーカーA社の内部監査改革\u003C/h3>\u003Cp>A社は、人工関節や整形外科用インプラントを製造する中堅医療機器メーカーです。以前は形式的な内部監査を年1回実施するのみで、その効果は限定的でした。しかし、新たに就任した品質保証部長の主導で、内部監査プログラムを大幅に見直し、以下のような改革を行いました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>リスクアプローチの導入：\u003C/strong> 製品のリスクレベルや過去の不適合履歴を考慮し、高リスク領域により多くの監査を割り当てました。\u003C/li>\u003Cli>\u003Cstrong>プロセスアプローチの採用：\u003C/strong> 個別の手順や記録のチェックだけでなく、前後のプロセスとの相互関係を考慮したプロセス全体の有効性を評価する方法に変更しました。\u003C/li>\u003Cli>\u003Cstrong>監査頻度の最適化：\u003C/strong> 年1回の全社一斉監査から、部門ごとにリスクに応じた最適な頻度（四半期ごと、半年ごとなど）で実施する方式に変更しました。\u003C/li>\u003Cli>\u003Cstrong>監査員のトレーニング強化：\u003C/strong> 内部監査員に対して、監査技法や最新の規制要件に関する定期的なトレーニングを実施しました。\u003C/li>\u003Cli>\u003Cstrong>経営層の関与強化：\u003C/strong> 監査結果を経営会議で定期的に報告し、必要な改善策を迅速に実施できる体制を整えました。\u003C/li>\u003C/ol>\u003Cp>これらの改革の結果、A社では以下のような成果が得られました：\u003C/p>\u003Cul>\u003Cli>重大な品質問題の\u003Cstrong>未然防止件数が前年比50%増加\u003C/strong>\u003C/li>\u003Cli>規制当局の査察での\u003Cstrong>指摘事項がゼロ\u003C/strong>に\u003C/li>\u003Cli>従業員の品質意識が向上し、\u003Cstrong>自発的な改善提案が増加\u003C/strong>\u003C/li>\u003C/ul>\u003Cp>この成功事例から、内部監査を形式的なものではなく、組織の継続的改善のための効果的なツールとして活用することの重要性が分かります。\u003C/p>\u003Ch3 id=\"h4b50952c80\">失敗事例：医療機器メーカーB社の内部監査の形骸化\u003C/h3>\u003Cp>B社は、糖尿病患者向けの血糖値測定器を製造する医療機器メーカーです。B社では、長年にわたり同じ方法で内部監査を実施しており、以下のような問題点がありました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>チェックリスト主義：\u003C/strong> チェックリストに基づいて監査を行っていましたが、チェックリストの見直しを実施しておらず、リストにない最新の要求事項への適合を見逃すことが多くありました。\u003C/li>\u003Cli>\u003Cstrong>内部監査の不公平：\u003C/strong> 内部監査手順が明確でなく、公平性が不十分であったため、監査がなれ合いの関係になっていました。\u003C/li>\u003Cli>\u003Cstrong>フォローアップの不足： \u003C/strong>監査で指摘された問題に対する改善活動が適切に行われているかの確認が不十分でした。\u003C/li>\u003Cli>\u003Cstrong>経営層の無関心： \u003C/strong>内部監査の結果が経営層に適切に報告されず、重要な問題が放置されていました。\u003C/li>\u003Cli>\u003Cstrong>形式的な是正処置：\u003C/strong> 監査での指摘事項に対して、根本原因の分析が不十分なまま表面的な対応に終始していました。\u003C/li>\u003C/ol>\u003Cp>これらの問題により、B社では以下のような事態が発生しました：\u003C/p>\u003Cul>\u003Cli>製造工程の重大な不適合が内部監査で発見されず、\u003Cstrong>市場クレームの増加\u003C/strong>につながった\u003C/li>\u003Cli>規制当局の査察で多数の指摘を受け、\u003Cstrong>製品の出荷停止処分\u003C/strong>を受けた\u003C/li>\u003Cli>品質問題による製品リコールが発生し、多\u003Cstrong>額の損失と企業イメージの低下\u003C/strong>を招いた\u003C/li>\u003Cli>従業員の品質意識が低下し、\u003Cstrong>ヒヤリハット報告も減少\u003C/strong>傾向にあった\u003C/li>\u003C/ul>\u003Cp>この失敗事例から、内部監査が形骸化すると、重大な品質問題を見逃し、企業にとって深刻な影響をもたらす可能性があることが分かります。効果的な内部監査を維持するためには、継続的な見直しと改善が不可欠です。\u003C/p>\u003Cp>これらの事例は、QMSにおける内部監査の重要性と、その実施方法が組織の成功に大きな影響を与えることを示しています。内部監査を効果的に実施し、その結果を組織の改善に活かすことで、製品の品質向上と顧客満足度の向上につなげることができます。\u003C/p>\u003Ch2 id=\"hbb36035bc4\">内部監査の実施方法\u003C/h2>\u003Cp>QMSにおける内部監査を効果的に実施するためには、体系的なアプローチが必要です。ここでは、内部監査の始め方について、わかりやすいガイドを提供します。また、必要な資料やリソースについても説明します。\u003C/p>\u003Ch3 id=\"hee26181f09\">\u003Cstrong>内部監査プログラムの策定：\u003C/strong>\u003C/h3>\u003Cul>\u003Cli>年間の監査計画を立てます。\u003C/li>\u003Cli>監査の範囲、頻度、方法を決定します。\u003C/li>\u003Cli>リスクアプローチを採用し、重要度の高い領域に重点を置きます。\u003C/li>\u003C/ul>\u003Ch3 id=\"h7ceb11fe11\">\u003Cstrong>監査チームの編成：\u003C/strong>\u003C/h3>\u003Cul>\u003Cli>適切な力量を持つ内部監査員を選任します。\u003C/li>\u003Cli>監査対象部門と利害関係のない人員を監査員に指定します。\u003C/li>\u003Cli>必要に応じて、外部の専門家を含めることも検討します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h2ef1259611\">\u003Cstrong>監査準備：\u003C/strong>\u003C/h3>\u003Cul>\u003Cli>監査スケジュールを作成し、関係者に通知します。\u003C/li>\u003Cli>過去の監査結果や関連文書をレビューします。\u003C/li>\u003Cli>監査チェックリストや質問事項を準備します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h727688a2d4\">\u003Cstrong>監査の実施：\u003C/strong>\u003C/h3>\u003Cul>\u003Cli>オープニングミーティングを行い、監査の目的と範囲を説明します。\u003C/li>\u003Cli>インタビュー、文書レビュー、現場観察を通じて要求事項への適合を示す証拠を収集します。\u003C/li>\u003Cli>発見事項を明確に記録し、被監査部門に確認します。\u003C/li>\u003Cli>クロージングミーティングで監査結果を被監査部門に報告し、意見交換を行います。\u003C/li>\u003C/ul>\u003Ch3 id=\"he52e5dbdfb\">\u003Cstrong>監査報告書の作成：\u003C/strong>\u003C/h3>\u003Cul>\u003Cli>監査結果をまとめ、強み、改善の機会、不適合事項を明確に記述します。\u003C/li>\u003Cli>客観的な証拠に基づいて報告書を作成します。\u003C/li>\u003Cli>報告書内容に関して被監査部門の合意を得ます。\u003C/li>\u003C/ul>\u003Ch3 id=\"hd0759eee66\">\u003Cstrong>フォローアップ\u003C/strong>：\u003C/h3>\u003Cul>\u003Cli>不適合事項に対する是正処置計画を確認します。\u003C/li>\u003Cli>是正処置の実施状況を確認し、有効性を評価します。\u003C/li>\u003Cli>必要に応じて、フォローアップ監査を実施します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h78da41e42d\">\u003Cstrong>継続的改善：\u003C/strong>\u003C/h3>\u003Cul>\u003Cli>監査プログラム自体の有効性を定期的に評価します。\u003C/li>\u003Cli>監査員のスキル向上のための教育訓練を実施します。\u003C/li>\u003Cli>監査結果を分析し、QMS全体の改善につなげます。\u003C/li>\u003C/ul>\u003Cp>内部監査の実施には時間と労力を要しますが、これらのステップとリソースを活用することで、QMSの継続的な改善と製品の品質向上につながる価値ある活動となります。\u003C/p>\u003Cp>内部監査は、自己点検と違い客観性、公平性を確保するために、内部監査員がかかわる業務の内部監査を自らが実施することはできません。内部監査員は社内の人間である必要はなく、社内で確保することが難しい場合は、外部の専門家へ依頼することも検討してください。\u003C/p>\u003Ch2 id=\"h52b7837d1d\">内部監査の効果的な運用方法\u003C/h2>\u003Cp>内部監査を効果的に運用するためには、適切なモニタリングと評価が不可欠です。また、内部監査の実施過程で直面する可能性のある課題とその対応方法を理解しておくことも重要です。この項目では、これらの点について詳しく解説します。\u003C/p>\u003Ch3 id=\"hb9e8ff209f\">モニタリングと評価方法\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>KPI（主要業績評価指標）の設定と追跡：\u003C/strong>\u003Cul>\u003Cli>内部監査の完了率（計画された監査のうち、実際に完了した割合）\u003C/li>\u003Cli>重大な不適合の発見件数と傾向\u003C/li>\u003Cli>是正処置の完了率と有効性\u003C/li>\u003Cli>監査員のパフォーマンス評価スコア\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>監査プログラムのレビュー：\u003C/strong>\u003Cul>\u003Cli>年に1回程度、監査プログラム全体の有効性をレビューします。\u003C/li>\u003Cli>監査範囲、頻度、方法が適切かどうかを評価します。\u003C/li>\u003Cli>必要に応じて、監査プログラムの見直しと改善を行います。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>監査員の評価：\u003C/strong>\u003Cul>\u003Cli>各監査の終了後、被監査部門からフィードバックを収集します。\u003C/li>\u003Cli>監査員のスキルと知識を定期的に評価し、必要な教育訓練を提供します。\u003C/li>\u003Cli>ピアレビューを実施し、監査手法の標準化と品質向上を図ります。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>経営層への報告：\u003C/strong>\u003Cul>\u003Cli>年に1回程度、マネジメントレビューで内部監査の結果と傾向を経営層に報告します。\u003C/li>\u003Cli>重大な発見事項や組織全体に影響を及ぼす問題については、速やかに報告します。\u003C/li>\u003Cli>監査結果に基づく是正活動の進捗状況を報告します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>外部評価の活用：\u003C/strong>\u003Cul>\u003Cli>認証機関による審査や規制当局の査察結果を内部監査プログラムの評価に活用します。\u003C/li>\u003Cli>必要に応じて、外部の専門家による内部監査プロセスの内部監査を受けます。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">よくある課題とその対応方法\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>課題：監査の客観性の確保 対応：\u003C/strong>\u003Cul>\u003Cli>内部監査員が担当する業務に関する監査は、第三者が実施するようにします。\u003C/li>\u003Cli>内部監査員の独立性を確保し、内部監査結果の客観性を確保します。\u003C/li>\u003Cli>外部の専門家を監査チームに加えることを検討します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：監査員のスキル不足 対応：\u003C/strong>\u003Cul>\u003Cli>定期的な教育訓練プログラムを実施し、監査技術と知識の向上を図ります。\u003C/li>\u003Cli>経験豊富な監査員とペアを組ませ、OJTを通じてスキルアップを図ります。\u003C/li>\u003Cli>外部の監査員研修や資格取得を奨励します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：被監査部門の抵抗や非協力的態度 対応：\u003C/strong>\u003Cul>\u003Cli>内部監査の目的と重要性について、トップマネジメントのコミットメントを組織全体に周知します。\u003C/li>\u003Cli>監査を「批判」ではなく「改善の機会」として位置づけ、ポジティブなアプローチを心がけます。\u003C/li>\u003Cli>被監査部門の負担を考慮し、効率的な監査スケジュールを立てます。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：フォローアップの不足 対応：\u003C/strong>\u003Cul>\u003Cli>是正処置の期限と責任者を明確にし、進捗を定期的に確認します。\u003C/li>\u003Cli>フォローアップ監査のスケジュールを監査プログラムに組み込みます。\u003C/li>\u003Cli>是正処置の有効性評価を確実に実施し、記録します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：監査結果の活用不足 対応：\u003C/strong>\u003Cul>\u003Cli>監査結果を分かりやすく可視化し、経営層や関係部門に効果的に伝達します。\u003C/li>\u003Cli>好事例や改善事例を組織内で共有し、水平展開を促進します。\u003C/li>\u003Cli>監査結果を品質目標の設定や事業計画の策定に活用します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：リスクベースアプローチの不足 対応：\u003C/strong>\u003Cul>\u003Cli>製品のリスク分類、過去の不適合履歴、プロセスの重要度などを考慮し、監査計画を立てます。\u003C/li>\u003Cli>リスク評価の手法を導入し、高リスク領域に重点的に監査リソースを配分します。\u003C/li>\u003Cli>新規プロセス、変更管理に関連する領域、重大な不適合が発生したプロセスを優先的に監査対象とします。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>課題：監査の形骸化 対応：\u003C/strong>\u003Cul>\u003Cli>定期的に監査員の力量を再評価します。\u003C/li>\u003Cli>監査プログラム全体の有効性を検証するため、マネジメントレビューで内部監査の結果と傾向を経営層に報告します。\u003C/li>\u003Cli>新たな規制要件や業界動向を監査項目に反映させ、常に最新の状況に対応します。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの課題に適切に対応することで、QMSにおける内部監査の効果を最大化し、組織の継続的改善に貢献することができます。内部監査は単なるコンプライアンスのためのツールではなく、組織の品質文化を醸成し、競争力を強化するための重要な活動であることを、常に意識して運用することが重要です。\u003C/p>\u003Ch2 id=\"ha214098e44\">まとめ\u003C/h2>\u003Cp>QMSにおける内部監査は、医療機器産業において品質管理システムの有効性を確保し、継続的改善を推進するための不可欠なツールです。本記事では、内部監査の定義と目的から始まり、その必要性、具体的な実施方法、効果的な運用方法まで、包括的に解説してきました。\u003C/p>\u003Cp>内部監査を効果的に実施することで、法規制への適合性確保、品質向上、リスク管理の強化、そして組織全体の品質文化の醸成につながります。しかし、形式的な実施や不適切な運用は、重大な品質問題の見逃しや組織の競争力低下を招く可能性があります。\u003C/p>\u003Cp>成功事例と失敗事例から学んだように、リスクアプローチの採用、内部監査員の力量確保、プロセスアプローチの導入、そして経営層の積極的な関与が、効果的な内部監査の鍵となります。また、継続的なモニタリングと評価、監査員のスキル向上、そして監査結果の有効活用も重要です。\u003C/p>\u003Cp>医療機器産業における品質管理の重要性は今後さらに高まると予想されます。QMSにおける内部監査を戦略的に活用し、組織の継続的改善と競争力強化につなげていくことが、これからの医療機器メーカーには求められるでしょう。\u003C/p>",{"url":135,"height":136,"width":137},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/9cfc3c6c9bde4d7db11713219c40b202/naibuy-min.webp",777,1228,"医療機器QMSにおける内部監査の定義、目的、必要性を解説。体系的な評価プロセスとしての役割を強調し、法規制遵守や品質向上への貢献を詳述。リスクアプローチやプロセスアプローチを取り入れた効果的な実施方法と、継続的改善のための運用方法を紹介。成功・失敗事例を通じて重要性を示し、組織の品質文化醸成と競争力強化に不可欠なツールとしての価値を明確化。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":140,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[142,146],{"id":143,"createdAt":144,"updatedAt":144,"publishedAt":144,"revisedAt":144,"name":145},"nb0tz2elt5","2024-09-25T00:33:31.198Z","内部監査",{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":148,"createdAt":149,"updatedAt":150,"publishedAt":149,"revisedAt":150,"title":151,"content":152,"eyecatch":153,"description":156,"reviewer":157,"category":159},"qms-design-development","2024-09-02T09:49:50.241Z","2025-04-24T02:32:59.385Z","QMSの設計開発とは？","\u003Ch2 id=\"h03f7ed9cac\">QMSにおける設計開発とは？\u003C/h2>\u003Ch3 id=\"h286faa8665\">具体的な定義\u003C/h3>\u003Cp>QMS（品質管理監督システム）における設計開発とは、医療機器の製造販売過程において、\u003Cstrong>製品の構想から実際の製造に至るまでの一連のプロセスを体系的に管理し、安全で高品質な医療機器を設計開発するための重要な活動\u003C/strong>です。具体的には、顧客ニーズの分析、製品仕様の決定、設計の検証と妥当性確認、製造プロセスの計画など、製品の誕生から市場投入までの全ての段階を包括します。\u003C/p>\u003Cp>この過程では、製品の安全性、有効性、信頼性を確保するために、厳密な品質管理基準に従って各段階を進めていきます。医療機器の場合、人の生命や健康に直接関わる製品であるため、特に高い水準の品質管理が求められます。\u003C/p>\u003Ch3 id=\"he2485005d0\">目的\u003C/h3>\u003Cp>QMSにおける設計開発の主な目的は、以下の通りです：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>安全で効果的な医療機器の開発\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製品の品質と信頼性の確保\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>リスクの最小化\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>規制要件への適合\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>開発プロセスの効率化と最適化\u003C/strong>\u003C/li>\u003C/ol>\u003Cp>この活動が重要である理由は多岐にわたります。まず、患者の安全を最優先に考える医療機器業界において、\u003Cstrong>設計段階から品質を作り込むことは不可欠です。\u003C/strong>適切な設計開発プロセスを通じて、潜在的な問題を早期に発見し、解決することができます。\u003C/p>\u003Cp>また、厳格な規制環境下にある医療機器業界では、各国の規制当局が定める基準を満たすことが製品の市場投入の前提条件となります。QMSに基づいた設計開発は、これらの規制要件への適合を確実にする上で重要な役割を果たします。\u003C/p>\u003Cp>さらに、体系的な設計開発プロセスを実施することで、\u003Cstrong>製品の開発期間の短縮やコスト削減\u003C/strong>にもつながります。問題の早期発見と解決、効率的なリソース配分、重複作業の削減などが可能となるからです。\u003C/p>\u003Cp>結果として、QMSにおける設計開発は、安全で高品質な医療機器を効率的に開発し、市場に投入するための基盤となる重要な活動と言えます。\u003C/p>\u003Ch2 id=\"h73775acad8\">QMSにおける設計開発の必要性\u003C/h2>\u003Ch3 id=\"h4a784b5a9d\">なぜ必要なのか？\u003C/h3>\u003Cp>QMSにおける設計開発が必要とされる理由は、主に以下の3点に集約されます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>患者の安全確保：\u003C/strong> 医療機器は人の生命や健康に直接影響を与える製品です。そのため、設計段階から安全性を最優先に考慮し、潜在的なリスクを最小限に抑える必要があります。QMSに基づいた設計開発プロセスを通じて、製品の安全性を体系的に検証し、確保することができます。\u003C/li>\u003Cli>\u003Cstrong>規制要件への適合：\u003C/strong> 医療機器業界は、各国の規制当局による厳格な規制の下にあります。例えば、日本では薬機法（医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律）、米国ではFDA（食品医薬品局）の規制、欧州ではMDR（医療機器規則）などが存在します。これらの規制に適合するためには、設計開発の各段階で要求事項を満たしていることを示す必要があります。QMSに基づいた設計開発は、これらの要件への適合を体系的に管理し、証明するための枠組みを提供します。\u003C/li>\u003Cli>\u003Cstrong>製品の品質と信頼性の向上：\u003C/strong> 医療機器の品質と信頼性は、患者の治療効果や医療従事者の業務効率に直結します。QMSにおける設計開発プロセスを通じて、製品の要求事項を明確にし、それらを満たすための設計を行い、さらに検証と妥当性確認を行うことで、高品質で信頼性の高い製品を開発することができます。\u003C/li>\u003C/ol>\u003Cp>これらの理由から、QMSにおける設計開発は医療機器産業において不可欠な活動となっています。\u003C/p>\u003Ch3 id=\"had4a1e1a63\">対象となる活動や範囲\u003C/h3>\u003Cp>QMSにおける設計開発の対象となる活動や範囲は、医療機器の構想から市場投入後の監視まで広範囲に及びます。具体的には以下のような活動が含まれます：\u003C/p>\u003Col>\u003Cli>市場調査と顧客ニーズの分析\u003C/li>\u003Cli>製品コンセプトの策定\u003C/li>\u003Cli>ユーザビリティ評価とリスクマネジメント\u003C/li>\u003Cli>設計要求事項の定義\u003C/li>\u003Cli>設計インプットの作成\u003C/li>\u003Cli>設計アウトプットの作成\u003C/li>\u003Cli>設計レビュー\u003C/li>\u003Cli>設計の検証（Verification）\u003C/li>\u003Cli>設計の妥当性確認（Validation）\u003C/li>\u003Cli>臨床評価（必要な場合）\u003C/li>\u003Cli>設計移管（量産製造プロセスへの移行）\u003C/li>\u003Cli>規制当局への申請準備\u003C/li>\u003Cli>市販後調査と製品改善\u003C/li>\u003Cli>設計変更の管理\u003Cp>\u003C/p>\u003C/li>\u003C/ol>\u003Cp>これらの活動は、製品のライフサイクル全体を通じて継続的に行われます。特に、設計の検証と妥当性確認は重要なプロセスです。設計の検証では、設計アウトプットが設計インプットの要求事項を満たしているかを確認します。一方、設計の妥当性確認では、最終製品が意図された用途や要求事項を満たしているかを確認します。\u003C/p>\u003Ch3 id=\"hffbdb49730\">導入によるメリット\u003C/h3>\u003Cp>QMSに基づいた設計開発プロセスを導入することで、以下のようなメリットが期待できます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>製品の安全性と有効性の向上：\u003C/strong> 体系的なアプローチにより、潜在的なリスクや問題点を早期に特定し、対処することができます。これにより、より安全で効果的な医療機器の開発が可能になります。\u003C/li>\u003Cli>\u003Cstrong>開発プロセスの効率化：\u003C/strong> 標準化された手順と文書化により、開発プロセスが明確になり、作業の重複や無駄を削減できます。また、問題の早期発見により、後工程での大幅な修正や手戻りを防ぐことができます。\u003C/li>\u003Cli>\u003Cstrong>規制対応の円滑化： \u003C/strong>QMSに基づいた設計開発プロセスは、多くの規制要件と整合しています。そのため、規制当局への申請や査察対応がスムーズになります。\u003C/li>\u003Cli>\u003Cstrong>品質文化の醸成：\u003C/strong> 組織全体で品質を重視する文化が醸成され、継続的な改善活動につながります。\u003C/li>\u003Cli>\u003Cstrong>市場競争力の強化：\u003C/strong> 高品質な製品を効率的に開発できることで、市場での競争力が向上します。また、顧客満足度の向上にもつながり、ブランド価値の向上が期待できます。\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの向上：\u003C/strong> 設計開発の各段階の文書化ならびに記録を残すことで、製品の設計履歴が明確になります。これは、設計開発中だけでなく市販後の問題発生時の原因究明や改善活動に役立ちます。\u003C/li>\u003Cli>\u003Cstrong>コスト削減：\u003C/strong> 効率的な開発プロセスと問題の早期発見により、開発コストを削減できます。また、市販後の不具合対応や回収のリスクも低減されるため、長期的なコスト削減にもつながります。\u003C/li>\u003Cli>\u003Cstrong>チーム間のコミュニケーション改善：\u003C/strong> 標準化されたプロセスと文書化により、開発に関わる異なる部門間（例：設計部門、製造部門、品質保証部門など）のコミュニケーションが円滑になります。\u003C/li>\u003C/ol>\u003Cp>これらのメリットにより、QMSにおける設計開発プロセスの導入は、医療機器メーカーにとって大きな価値をもたらします。安全性と品質の向上、効率的な開発、規制対応の円滑化など、多面的な利点が得られるため、競争の激しい医療機器業界において重要な差別化要因となり得ます。\u003C/p>\u003Ch2 id=\"h86dd321198\">QMSにおける設計開発の具体例\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Ch3 id=\"hbbc96b1794\">成功事例：新型血糖値モニタリングシステムの開発\u003C/h3>\u003Cp>医療機器メーカーA社は、従来の血糖値測定器に比べて、より正確で使いやすい新型血糖値モニタリングシステムの開発に成功しました。この成功の背景には、QMSに基づいた綿密な設計開発プロセスがありました。\u003C/p>\u003Col>\u003Cli>\u003Cstrong>市場調査とニーズ分析：\u003C/strong> A社は、糖尿病患者や医療従事者に対して詳細な調査を行い、既存製品の課題や新しいニーズを特定しました。その結果、「より少ない血液量での測定」「データの自動記録と共有機能」「長時間の連続モニタリング」などのニーズが明らかになりました。\u003C/li>\u003Cli>\u003Cstrong>ユーザビリティ評価とリスクマネジメント： \u003C/strong>開発初期段階で、ユーザビリティ評価、ならびにリスクマネジメントを実施し、潜在的なリスクを特定し、評価しました。例えば、測定精度の低下、バッテリー寿命、誤使用、データセキュリティなどのリスクが挙げられ、それぞれに対する対策を設計に組み込みました。\u003C/li>\u003Cli>\u003Cstrong>設計要求事項の定義：\u003C/strong> 市場調査とリスク分析の結果を基に、具体的な設計要求事項（設計インプット）を定義しました。例えば、「血液量0.3μLでの測定」「測定精度±5%以内」「7日間の連続モニタリング」「クラウドへのリアルタイムデータ送信」などが含まれました。\u003C/li>\u003Cli>\u003Cstrong>設計・開発：\u003C/strong> 設計チームは、要求事項に基づいて製品の詳細設計を行いました。この過程で、新しいセンサー技術の採用、小型化設計、ユーザーインターフェースの最適化などが行われました。\u003C/li>\u003Cli>\u003Cstrong>設計レビュー：\u003C/strong> 開発の各段階で、関連部門（設計開発、営業、製造、薬事、品質保証など）による設計レビューを実施し、設計の妥当性や実現可能性を評価しました。これにより、早期に潜在的な問題を発見し、解決することができました。\u003C/li>\u003Cli>\u003Cstrong>プロトタイプ作成と検証：\u003C/strong> 設計に基づいてプロトタイプを作成し、厳密な検証試験を行いました。この段階で、測定精度や耐久性などの要求事項への適合を確認しました。\u003C/li>\u003Cli>\u003Cstrong>臨床評価： \u003C/strong>実際の使用環境に近い条件下で臨床評価を実施し、製品の有効性と安全性を確認しました。この過程で、ユーザビリティの改善点も特定されました。\u003C/li>\u003Cli>\u003Cstrong>設計の妥当性確認：\u003C/strong> 最終的な製品設計が、当初の要求事項と意図された用途に適合していることを確認しました。臨床評価結果、ユーザビリティ評価結果も含め、製品が期待通りの性能を発揮することを確認しました。\u003C/li>\u003Cli>\u003Cstrong>製造移管と量産準備：\u003C/strong> 設計開発チームは、製造部門と緊密に連携し、スムーズな製造移管を実現しました。製造プロセスのバリデーションを通じて、一貫した品質の製品が製造できることを確認しました。\u003C/li>\u003Cli>\u003Cstrong>規制対応と承認取得：\u003C/strong> 開発の各段階で生成された文書と記録を基に、規制当局への申請資料を作成しました。QMSに基づいた体系的な開発プロセスにより、承認取得がスムーズに進みました。\u003C/li>\u003C/ol>\u003Cp>この成功事例では、QMSに基づいた設計開発プロセスにより、市場ニーズに合致した高品質な製品を効率的に開発し、迅速に市場投入することができました。結果として、A社の新型血糖値モニタリングシステムは、市場で高い評価を得ることができました。\u003C/p>\u003Ch3 id=\"h47024fc448\">失敗事例：体内埋め込み型医療機器の設計不備\u003C/h3>\u003Cp>一方で、QMSにおける設計開発プロセスが適切に実施されなかった場合、深刻な問題につながる可能性があります。以下は、医療機器メーカーB社の体内埋め込み型医療機器開発における失敗事例です。\u003C/p>\u003Col>\u003Cli>\u003Cstrong>不十分なリスク分析：\u003C/strong> B社は、新しい材料を使用した体内埋め込み型医療機器の開発を行いました。しかし、新材料の長期的な生体適合性に関するリスク分析が不十分でした。QMSに基づく適切なリスク管理プロセスが実施されていれば、この潜在的なリスクを早期に特定し、対策を講じることができたはずです。\u003C/li>\u003Cli>\u003Cstrong>不適切な設計検証： \u003C/strong>設計段階で、新材料の特性に関する十分な検証が行われませんでした。特に、生体内での長期使用に伴う材料の劣化や変性に関する検証が不十分でした。QMSに基づく厳格な設計検証プロセスがあれば、この問題を開発段階で発見できた可能性があります。\u003C/li>\u003Cli>\u003Cstrong>臨床評価の不備： \u003C/strong>臨床評価の検体数が少なく、長期的な安全性と有効性の評価が不十分でした。QMSに基づく適切な臨床評価計画があれば、より長期的かつ包括的な評価が行われたはずです。\u003C/li>\u003Cli>\u003Cstrong>製造プロセスの検証不足：\u003C/strong> 設計から製造への移行が急がれ、製造プロセス設計の十分な検証が行われませんでした。その結果、量産段階で製品の品質にばらつきが生じました。QMSに基づく適切な設計開発と製造プロセスのバリデーションが実施されていれば、この問題を防ぐことができたでしょう。\u003C/li>\u003Cli>\u003Cstrong>市販後調査の不備：\u003C/strong> 製品の市販後、患者から軽微な不具合の報告がありましたが、十分な調査が行われませんでした。QMSに基づく適切な市販後調査と苦情処理、是正措置のプロセスがあれば、早期に問題を特定し対処できたはずです。\u003C/li>\u003C/ol>\u003Cp>結果として、市販から2年後、一部の患者で重篤な副作用が報告され、\u003Cstrong>製品の大規模な回収に至りました。\u003C/strong>この事態は、患者の健康被害だけでなく、B社の\u003Cstrong>信頼性と財務状況に深刻な影響を与えました。\u003C/strong>\u003C/p>\u003Cp>この失敗事例は、QMSに基づく設計開発プロセスの重要性を如実に示しています。適切なリスク管理、設計検証、臨床評価、製造プロセスの検証、市販後調査など、QMSの各要素が適切に実施されていれば、この問題を防ぐ、あるいは早期に発見し対処することができた可能性が高いと言えます。\u003C/p>\u003Ch2 id=\"h9be69b95a4\">QMSにおける設計開発の進め方\u003C/h2>\u003Cp>QMSにおける設計開発プロセスを効果的に実施するためのガイドを以下に示します。このガイドは、医療機器の設計開発に携わる企業や組織が、体系的かつ効率的にプロセスを進めるための基本的なステップを提供します。\u003C/p>\u003Ch3 id=\"h05d1615eb3\">1. プロジェクト計画の立案\u003C/h3>\u003Cul>\u003Cli>プロジェクトの目的、範囲、タイムライン、必要なリソースを明確にします。\u003C/li>\u003Cli>設計開発チームを編成し、各メンバーの役割と責任を定義します。\u003C/li>\u003Cli>規制要件を確認し、必要な設計開発ステップと承認プロセスを計画に組み込みます。\u003C/li>\u003C/ul>\u003Ch3 id=\"h75662f2b98\">2.  製品要求事項の定義\u003C/h3>\u003Cul>\u003Cli>市場調査や顧客フィードバックに基づいて、製品に求められる要求事項を特定します。\u003C/li>\u003Cli>要求事項に抜け漏れ、不整合がないかを製品関連部署（設計開発、営業、薬事、製造、サプライチェーンなど）で確認します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h5e7cf54299\">3. ユーザビリティ評価、リスクマネジメントの実施\u003C/h3>\u003Cul>\u003Cli>EC62366-1ユーザビリティエンジニアリング、およびISO 14971に基づいてリスクマネジメントプロセスを実施します。\u003C/li>\u003Cli>潜在的な危害を特定し、リスク評価を行います。\u003C/li>\u003Cli>リスク低減策を検討し、設計に反映させます。\u003C/li>\u003C/ul>\u003Ch3 id=\"h71463403fa\">4. 設計インプットの定義\u003C/h3>\u003Cul>\u003Cli>製品要求事項、ユーザビリティ評価、ならびにリスクマネジメントの結果を技術的要求事項、性能要求事項、安全性要求事項、規制要求事項、使用性要求事項などに分類し、具体的な設計仕様を明確にします。\u003C/li>\u003Cli>すべての要求事項を文書化し、レビューを行います。\u003C/li>\u003C/ul>\u003Ch3 id=\"h227bd7dd07\">5. 設計アウトプットの作成\u003C/h3>\u003Cul>\u003Cli>設計インプットに基づいて、詳細な設計仕様を作成します。\u003C/li>\u003Cli>図面、回路図、ソフトウェア仕様書、材料仕様書などを作成します。\u003C/li>\u003Cli>設計アウトプットが設計インプットの要求事項を満たしていることを確認します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h37317c9582\">6. 設計の検証（Verification）\u003C/h3>\u003Cul>\u003Cli>設計アウトプットが設計インプットの要求事項を満たしていることを客観的に確認します。\u003C/li>\u003Cli>試験計画を立案し、必要な試験（機能試験、安全性試験、耐久性試験など）を実施します。\u003C/li>\u003Cli>試験結果を文書化し、不適合があった場合は是正措置を講じます。\u003C/li>\u003C/ul>\u003Ch3 id=\"h0acaa358ed\">7. 設計レビューの実施\u003C/h3>\u003Cul>\u003Cli>開発の各段階で、関連部門によるレビューを実施します。\u003C/li>\u003Cli>設計の妥当性、実現可能性、リスク対策の適切性などを評価し、新たな問題が発生していないか評価します。\u003C/li>\u003Cli>レビュー結果を文書化し、必要な改善策を実施します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h233066db9d\">8. 設計の妥当性確認（Validation）\u003C/h3>\u003Cul>\u003Cli>最終製品が意図された用途や要求事項を満たしていることを確認します。\u003C/li>\u003Cli>臨床評価や使用性評価を含む、実際の使用条件に近い環境での評価を行います。\u003C/li>\u003Cli>結果を文書化し、製品が期待される性能と安全性を有していることを確認します。\u003C/li>\u003C/ul>\u003Ch3 id=\"hac15894fa4\">9. 製造工程設計\u003C/h3>\u003Cul>\u003Cli>設計開発した製品を量産化するための製造工程インプットをもとに製造工程を設計します。\u003C/li>\u003Cli>製造設備・機器の適格性を確認します。\u003C/li>\u003Cli>製造方法、試験方法、教育訓練方法を確立し、製造プロセスのバリデーションを行い、一貫した品質の製品が製造できることを確認します。\u003C/li>\u003Cli>設計の妥当性確認を実施する際に用いたサンプルが本量産製造工程で製造されたサンプルでない場合は、その同等性を検証します。\u003C/li>\u003C/ul>\u003Ch3 id=\"he184c6815e\">10. 設計移管\u003C/h3>\u003Cul>\u003Cli>設計開発段階から量産製造段階への移行を計画し、量産製造するために必要な知識、文書、記録を製造部門に移管します。\u003C/li>\u003C/ul>\u003Ch3 id=\"hdff83502b6\">11. 設計変更管理\u003C/h3>\u003Cul>\u003Cli>設計変更の必要性が生じた場合、変更管理プロセスを通じて実施します。\u003C/li>\u003Cli>変更の影響を評価し、必要な検証と妥当性確認を行います。\u003C/li>\u003Cli>変更を文書化し、関連する文書を更新します。\u003C/li>\u003C/ul>\u003Ch3 id=\"h7f0d257d4c\">12. 設計履歴ファイル（DHF）の作成\u003C/h3>\u003Cul>\u003Cli>設計開発プロセス全体を通じて生成された文書や記録を体系的に管理します。\u003C/li>\u003Cli>設計インプット、アウトプット、検証結果、妥当性確認結果、変更履歴などを含めます。\u003C/li>\u003Cli>DHFは規制当局の査察時や、将来の製品改良時の重要な参考資料となります。\u003C/li>\u003C/ul>\u003Cp>これらのステップを活用することで、QMSに基づいた体系的な設計開発プロセスを実施することができます。ただし、各組織の特性や開発する医療機器の特性に応じて、このプロセスをカスタマイズすることが重要です。また、規制要件や業界標準の変更に常に注意を払い、プロセスを適宜更新していく必要があります。\u003C/p>\u003Ch2 id=\"h6dd4284488\">QMSにおける設計開発の効果的な運用方法\u003C/h2>\u003Cp>QMSにおける設計開発プロセスを効果的に運用するためには、継続的なモニタリングと評価、そして発生する課題への適切な対応が不可欠です。以下に、効果的な運用方法とよくある課題への対応策を示します。\u003C/p>\u003Ch3 id=\"hb9e8ff209f\">モニタリングと評価方法\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>キーパフォーマンス指標（KPI）の設定と監視：\u003C/strong>\u003Cul>\u003Cli>開発期間、コスト、品質指標などのKPIを設定し、定期的に測定・評価します。\u003C/li>\u003Cli>例：設計変更回数、設計レビューでの指摘事項数、試験不適合率など\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>マイルストーンレビューの実施：\u003C/strong>\u003Cul>\u003Cli>プロジェクトの重要な節目でレビューを行い、進捗状況と品質を評価します。\u003C/li>\u003Cli>必要に応じて、計画の見直しや是正措置を講じます。\u003C/li>\u003Cli>設計レビュー時に実施してもかまいません。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>リスク管理の継続的な評価：\u003C/strong>\u003Cul>\u003Cli>定期的にリスク評価を見直し、新たなリスクの特定や既存リスクの再評価を行います。\u003C/li>\u003Cli>リスク低減策の有効性を継続的に確認します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>内部監査の実施：\u003C/strong>\u003Cul>\u003Cli>定期的に設計開発プロセスの内部監査を行い、QMS要求事項への適合性を確認します。\u003C/li>\u003Cli>監査結果に基づいて、プロセスの改善を図ります。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>設計レビューの効果性評価：\u003C/strong>\u003Cul>\u003Cli>設計開発の各段階におけるアウトプットをレビューし、製品の有効性や効率性を評価します。\u003C/li>\u003Cli>要求事項の変更が適切に製品に反映されているか確認します。\u003C/li>\u003Cli>必要に応じて、設計開発プロセスの改善を行います。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>顧客フィードバックの収集と分析：\u003C/strong>\u003Cul>\u003Cli>市販後の製品に対する顧客フィードバックを積極的に収集し、分析します。\u003C/li>\u003Cli>新たなリスクが発見された場合はリスクマネジメントを実施します。\u003C/li>\u003Cli>得られた知見を当該製品、ならびに今後の設計開発プロセスに反映させます。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの確保：\u003C/strong>\u003Cul>\u003Cli>設計要求事項から設計移管までの文書、記録のトレーサビリティを確保します。\u003C/li>\u003Cli>設計開発各段階の文書、記録が設計開発履歴簿に含まれているか確認します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>変更管理の妥当性：\u003C/strong>\u003Cul>\u003Cli>要求事項の変更、原材料、部品、製造プロセスの変更が適切に評価されているか確認します。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">よくある課題とその対応方法\u003C/h3>\u003Col>\u003Cli>\u003Cstrong>スケジュールの遅延：\u003C/strong>\u003Cul>\u003Cli>課題：複雑な要求事項や予期せぬ技術的問題により、開発スケジュールが遅延する。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>クリティカルパスの明確化と重点的な管理\u003C/li>\u003Cli>リスクベースのアプローチによる優先順位付け\u003C/li>\u003Cli>並行開発や迅速なプロトタイピングの活用\u003C/li>\u003Cli>担当者責務の明確化\u003C/li>\u003Cli>定期的な進捗管理の実施\u003Cp>\u003C/p>\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>部門間のコミュニケーション不足：\u003C/strong>\u003Cul>\u003Cli>課題：設計、製造、品質保証など、異なる部門間でのコミュニケーション不足により、問題が後工程で発見される。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>クロスファンクショナルチームの編成\u003C/li>\u003Cli>定期的な部門横断会議の開催\u003C/li>\u003Cli>情報共有プラットフォームの活用\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>規制要件への適合性確保：\u003C/strong>\u003Cul>\u003Cli>課題：複雑化・厳格化する規制要件への適合が困難になる。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>規制動向の継続的なモニタリングと社内への周知\u003C/li>\u003Cli>規制要件のチェックリスト作成と定期的な確認\u003C/li>\u003Cli>薬事、品質保証との密接なコミュニケーション\u003C/li>\u003Cli>必要に応じて規制当局との事前相談の実施\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>設計変更の管理：\u003C/strong>\u003Cul>\u003Cli>課題：頻繁な設計変更により、文書管理や影響評価が複雑化する。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>変更管理プロセスの最適化と自動化\u003C/li>\u003Cli>変更の影響を可視化するツールの活用\u003C/li>\u003Cli>設計担当者、供給業者、製造業者への周知徹底\u003C/li>\u003Cli>変更審査委員会の設置による変更の適切性評価\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>リソースの最適配分：\u003C/strong>\u003Cul>\u003Cli>課題：複数のプロジェクトが並行して進行する中、限られたリソースを適切に配分することが難しい。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>ポートフォリオマネジメントの導入\u003C/li>\u003Cli>リソース配分の優先順位付けと定期的な見直し\u003C/li>\u003Cli>スキルマトリックスの作成と活用\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>技術的課題の解決：\u003C/strong>\u003Cul>\u003Cli>課題：新技術の導入や複雑な要求事項により、技術的な課題が発生する。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>早期のフィージビリティスタディの実施\u003C/li>\u003Cli>外部専門家や研究機関との連携\u003C/li>\u003Cli>段階的な技術導入アプローチの採用\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>品質目標の達成：\u003C/strong>\u003Cul>\u003Cli>課題：高い品質基準を満たしつつ、開発効率を向上させることが難しい。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>品質目標の明確化と全社的な共有\u003C/li>\u003Cli>デザインフォーシックス（DFS）の導入\u003C/li>\u003Cli>継続的な品質改善活動の推進\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>文書化の負担：\u003C/strong>\u003Cul>\u003Cli>課題：QMSに基づく詳細な文書化要求により、開発者の負担が増大する。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>文書テンプレートの整備と標準化\u003C/li>\u003Cli>文書管理システムの導入による効率化\u003C/li>\u003Cli>重複文書の削減化\u003C/li>\u003Cli>文書作成トレーニングの実施\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの方策を組み合わせることで、QMSにおける設計開発プロセスをより効果的に運用することができます。\u003Cstrong>重要なのは、これらの課題に対して事後対応ではなく、予防的なアプローチを取ることです。\u003C/strong>定期的なプロセスの見直しと改善、そして組織全体での品質文化の醸成が、長期的な成功につながります。\u003C/p>\u003Cp>さらに、以下の点にも注意を払うことで、QMSにおける設計開発の運用をより効果的にすることができます：\u003C/p>\u003Col start=\"9\">\u003Cli>\u003Cstrong>継続的な教育と訓練：\u003C/strong>\u003Cul>\u003Cli>課題：QMSや最新の規制要件に関する知識が組織内で不足している。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>定期的な社内トレーニングの実施\u003C/li>\u003Cli>外部セミナーや講習会への参加奨励\u003C/li>\u003Cli>e-learningシステムの導入による自己学習の促進\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>サプライヤー管理：\u003C/strong>\u003Cul>\u003Cli>課題：重要な部品やサービスを提供するサプライヤーの品質管理が不十分。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>社内要求事項の明確化\u003C/li>\u003Cli>サプライヤー評価システムの構築と定期的な監査\u003C/li>\u003Cli>サプライヤーとの品質契約の締結\u003C/li>\u003Cli>サプライヤーとの共同開発プログラムの実施\u003C/li>\u003Cli>サプライヤー評価システムの構築と定期的な監査\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>デジタル技術の活用：\u003C/strong>\u003Cul>\u003Cli>課題：従来の紙ベースのプロセスでは効率が悪く、エラーも発生しやすい。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>電子文書管理システムの導入\u003C/li>\u003Cli>デジタルツインを活用した設計検証\u003C/li>\u003Cli>AIやビッグデータ分析の活用による予測的品質管理\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>グローバル規制対応：\u003C/strong>\u003Cul>\u003Cli>課題：国際市場展開に伴い、複数国の規制に同時に対応する必要がある。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>グローバル規制情報データベースの構築\u003C/li>\u003Cli>地域ごとの規制専門家の育成\u003C/li>\u003Cli>複数規制に対応した設計開発プロセスの確立\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>ユーザビリティエンジニアリングの統合：\u003C/strong>\u003Cul>\u003Cli>課題：製品の使いやすさや人間工学的側面が十分に考慮されていない。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>ユーザビリティ専門家の育成と設計開発初期段階からの参画\u003C/li>\u003Cli>設計初期段階からのユーザビリティ専門家の参画\u003C/li>\u003Cli>ユーザビリティテストの体系的な実施\u003C/li>\u003Cli>ユーザーフィードバックの継続的な収集と分析\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>サイバーセキュリティ対策：\u003C/strong>\u003Cul>\u003Cli>課題：連携機器や医療機器へのサイバー攻撃リスクが増大している。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>サイバーセキュリティ対応の手順化\u003C/li>\u003Cli>設計段階からのセキュリティ対策の組み込み\u003C/li>\u003Cli>定期的な脆弱性評価とペネトレーションテストの実施\u003C/li>\u003Cli>セキュリティインシデント対応計画の策定\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>持続可能性への配慮：\u003C/strong>\u003Cul>\u003Cli>課題：環境負荷や持続可能性への配慮が不十分。\u003C/li>\u003Cli>対応：\u003Cul>\u003Cli>ライフサイクルアセスメントの実施\u003C/li>\u003Cli>環境に配慮した材料選択や設計手法の採用\u003C/li>\u003Cli>リサイクルや再利用を考慮した設計\u003C/li>\u003C/ul>\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの対応策を適切に組み合わせ、組織の特性や開発する医療機器の特性に応じてカスタマイズすることが重要です。また、\u003Cstrong>QMSにおける設計開発プロセスは、固定的なものではなく、常に改善の余地があることを認識し、PDCAサイクルを回し続けることが肝要です。\u003C/strong>\u003C/p>\u003Cp>組織のトップマネジメントのコミットメント、従業員の積極的な参加、そして顧客や規制当局とのオープンなコミュニケーションを通じて、QMSにおける設計開発プロセスを継続的に改善していくことができます。これにより、安全で効果的な医療機器を効率的に開発し、患者さんの生活の質の向上に貢献することが可能となります。\u003C/p>\u003Ch2 id=\"ha214098e44\">まとめ\u003C/h2>\u003Cp>QMSにおける設計開発プロセスは、医療機器産業において安全性、有効性、そして品質を確保するための重要な基盤です。これは\u003Cstrong>単なる規制要件への対応ではなく、患者の安全を守り、医療の質を向上させるための戦略的なアプローチです。\u003C/strong>\u003C/p>\u003Cp>本記事で見てきたように、QMSに基づく設計開発プロセスは、市場調査からリスク管理、設計検証、妥当性確認、設計変更、そして市販後管理に至るまで、製品のライフサイクル全体をカバーする包括的なフレームワークを提供します。このプロセスを適切に実施することで、潜在的な問題を早期に発見し、効率的な開発を実現し、規制要件への適合を確実にすることができます。\u003C/p>\u003Cp>しかし、QMSにおける設計開発プロセスの\u003Cstrong>効果的な運用には、継続的な改善と柔軟な対応が求められます\u003C/strong>。技術の進歩、規制環境の変化、そして市場ニーズの多様化に伴い、常に新たな課題が生じます。これらの課題に対して、組織は先を見越した対策を講じ、プロセスを最適化し続ける必要があります。\u003C/p>\u003Cp>最終的に、QMSにおける設計開発プロセスの成功は、安全で効果的な医療機器の提供を通じて、\u003Cstrong>患者の生活の質向上に貢献\u003C/strong>することにあります。この目標を常に念頭に置き、\u003Cstrong>組織全体で品質文化を醸成し、継続的な改善に取り組むことが、医療機器産業の発展と社会への貢献につながるのです。\u003C/strong>\u003C/p>",{"url":154,"height":155,"width":116},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/96b6e93b49d942d9ac97b9e4e0ae9aaa/sekkei1-min.webp",789,"QMSにおける設計開発の定義、目的、必要性を詳細に解説。医療機器の安全性、有効性、品質確保への貢献を強調。製品ライフサイクル全体をカバーする包括的なプロセスとしての役割を明確化。成功・失敗事例を通じてその重要性を示し、効果的な実施方法と運用上の課題への対応策を提示。継続的改善の重要性を強調し、患者安全と医療の質向上に不可欠な戦略的アプローチとしての価値を明示。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":158,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[160,164],{"id":161,"createdAt":162,"updatedAt":162,"publishedAt":162,"revisedAt":162,"name":163},"j08y84nh45o","2024-09-02T09:50:07.659Z","設計開発",{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"id":166,"createdAt":167,"updatedAt":168,"publishedAt":169,"revisedAt":168,"title":170,"content":171,"eyecatch":172,"description":175,"reviewer":176,"category":178},"process-validation","2024-10-06T14:31:39.173Z","2024-10-22T06:18:26.979Z","2024-10-16T06:53:04.677Z","QMSの製造工程バリデーションとは？","\u003Ch2 id=\"h8913e67145\">\u003Cstrong>製造工程バリデーションとは？\u003C/strong>\u003C/h2>\u003Cp>製造工程バリデーションは、医療機器の製造管理において極めて重要な要素です。この概念は、製造プロセスが一貫して品質基準を満たす製品を生産できることを科学的に実証し、文書化する体系的なプロセスを指します。\u003C/p>\u003Cp>この製造工程バリデーションには、製造工程設備・機器に搭載されているプログラムや、製造管理で使用する単体プログラムも含まれています。\u003C/p>\u003Cp>つまり、製造工程バリデーションは、製造プロセス全体の信頼性と再現性を確保するための手法なのです。\u003C/p>\u003Cp>具体的な定義としては、製造工程バリデーションは「\u003Cstrong>特定の工程が一貫して、事前に定められた規格および品質特性に適合する製品を生産できることを、客観的な証拠を通じて確立する文書化されたプロセス\u003C/strong>」と言えます。この定義は、日本の厚生労働省や米国食品医薬品局（FDA）などの規制当局によって広く認められています。\u003C/p>\u003Cp>主な目的には以下のようなものがあります：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>製品品質の一貫性確保\u003C/strong>：バリデーションを通じて、製造プロセスが常に一定の品質基準を満たす製品を生産できることを保証します。\u003C/li>\u003Cli>\u003Cstrong>リスク低減\u003C/strong>：製造過程で検証が難しい品質基準への適合性を客観的に評価し、対策を講じることで、製品関連のリスクを最小限に抑えます。\u003C/li>\u003Cli>\u003Cstrong>規制要件の遵守\u003C/strong>：多くの国の規制当局が医療機器製造におけるバリデーションを要求しており、これを実施することで法的要件を満たします。\u003C/li>\u003Cli>\u003Cstrong>効率性の向上\u003C/strong>：バリデーションプロセスを通じて、製造工程の非効率な作業を特定し、改善することができます。\u003C/li>\u003Cli>\u003Cstrong>顧客信頼の獲得\u003C/strong>：厳格な品質管理プロセスの存在は、製品の信頼性を高め、顧客満足度の向上につながります。\u003C/li>\u003C/ol>\u003Cp>製造工程バリデーションは、単なる形式的な手続きではありません。それは、製品の設計段階から始まり、製造プロセスの開発、実際の生産、そして製品の市場投入後のモニタリングまで、製品のライフサイクル全体にわたる継続的なプロセスです。\u003C/p>\u003Cp>このプロセスには、以下のような要素が含まれます：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>プロセスデザインの検証\u003C/strong>：製造プロセスが適切に設計され、目的を達成できるかを評価します。\u003C/li>\u003Cli>\u003Cstrong>設備、機器やシステムの適格性評価\u003C/strong>：使用する設備、機器および製造システムが意図した目的に適していることを確認します。\u003C/li>\u003Cli>\u003Cstrong>プロセスパラメータの最適化\u003C/strong>：製造プロセスの各段階で最適な条件を特定し、設定します。\u003C/li>\u003Cli>\u003Cstrong>検証バッチの製造と評価\u003C/strong>：実際の生産条件下で製品を製造し、品質基準を満たしているかを確認します。\u003C/li>\u003Cli>\u003Cstrong>継続的なプロセスモニタリング\u003C/strong>：製造プロセスの性能を定期的に評価し、必要に応じて改善を行います。\u003C/li>\u003C/ul>\u003Cp>製造工程バリデーションは、医療機器の品質と安全性を確保するための重要なツールです。適切に実施することで、製造業者は高品質な製品を一貫して生産し、患者の安全を守り、規制要件を満たすことができるのです。\u003C/p>\u003Ch2 id=\"he4d3aa158e\">\u003Cstrong>製造工程バリデーションの必要性\u003C/strong>\u003C/h2>\u003Cp>医療機器産業において、製造工程バリデーションは単なる規制要件の一つではなく、製品の品質、安全性、そして最終的には患者の健康を守るための不可欠な要素です。その必要性は、製品の特性や製造プロセスの複雑さが増すにつれ、ますます高まっています。\u003C/p>\u003Cp>製造工程バリデーションを導入することで、以下のような多くのメリットが得られます：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>高度な品質保証\u003C/strong>：　バリデーションでは、人による検証が難しい作業や、検証に多大な時間と労力を必要とする工程に対して、高度な品質保証を行うことができます。\u003C/li>\u003Cli>\u003Cstrong>品質の一貫性\u003C/strong>： バリデーションを通じて、製造プロセスが常に一定の品質基準を満たす製品を生産できることが保証されます。これにより、品質のばらつきを最小限に抑え、安定した製品供給が可能になります。\u003C/li>\u003Cli>\u003Cstrong>リスク管理の強化\u003C/strong>： 製造工程の各段階で潜在的な品質のばらつきリスクを特定し、それらに対する対策を講じることができます。これにより、製品不良や製造ミスによる承認事項からの逸脱や健康被害のリスクを大幅に低減できます。\u003C/li>\u003Cli>\u003Cstrong>規制遵守の保証\u003C/strong>： 多くの国の規制当局が医療機器製造におけるバリデーションを要求しています。適切なバリデーションを実施することで、これらの規制要件を確実に満たすことができます。\u003C/li>\u003Cli>\u003Cstrong>コスト削減：\u003C/strong> 初期段階でバリデーションを適用する工程を特定し、バリデーションを実施することで、製造時の不良品発生頻度の減少や市場での品質問題発生の減少など、高コストな事態を回避できます。長期的には、品質管理にかかる全体的なコストの削減につながります。\u003C/li>\u003Cli>\u003Cstrong>市場競争力の向上\u003C/strong>： 高品質な製品を一貫して提供することで、企業の評判が向上し、市場での競争力が強化されます。\u003C/li>\u003Cli>\u003Cstrong>継続的改善の促進\u003C/strong>： バリデーションプロセスを通じて得られたデータと知見は、製造プロセスの継続的な改善に活用できます。これにより、長期的な品質向上と効率化が可能になります。\u003C/li>\u003Cli>\u003Cstrong>トレーサビリティの向上\u003C/strong>： バリデーションプロセスの文書化により、製品の製造履歴が明確になり、問題発生時の原因究明や対策立案が容易になります。\u003C/li>\u003C/ol>\u003Cp>製造工程バリデーションの対象となる活動や範囲は非常に広範囲に及びます。具体的には以下のような領域が含まれます：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>原材料の受入検査プロセス\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製造環境の管理（温度、湿度、清浄度など）\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製造・品質管理設備の運転パラメータ設定と管理\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製造工程の各段階（成形、組立、滅菌、表示包装など）\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>中間製品および最終製品の検査方法\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>保管および輸送条件の管理\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製造記録管理、トレーサビリティシステム（製品出入庫管理システム）\u003C/strong>\u003C/li>\u003C/ul>\u003Cp>これらの活動は、製品の種類や複雑さによって異なりますが、基本的にはすべての医療機器製造および品質管理プロセスがバリデーションの対象となります。特に、患者の安全に直接影響を与える可能性のある重要工程（例：滅菌プロセス、無菌充填など）については、より厳密なバリデーションが要求されます。\u003C/p>\u003Cp>製造工程バリデーションは、単なる規制上の要件を満たすためのプロセスではありません。それは、製品の品質と安全性を確保し、患者の健康を守るための重要なツールなのです。適切に実施されたバリデーションは、製造業者に多くの利点をもたらすとともに、最終的には医療の質の向上に貢献します。そのため、医療機器製造業界では、バリデーションを品質管理システムの中核的な要素として位置づけ、継続的に改善を行っていくことが求められています。\u003C/p>\u003Ch2 id=\"h22fbff4ed2\">\u003Cstrong>製造工程バリデーションの具体例\u003C/strong>\u003C/h2>\u003Cp>※本記事で紹介している具体例や数値は、説明のために作成したイメージであり、実在の企業を基にしたものではありません。\u003C/p>\u003Cp>製造工程バリデーションの重要性をより深く理解するために、医療機器業界における成功事例と失敗事例をそれぞれ1つずつ詳しく見ていきましょう。これらの例を通じて、適切なバリデーションの実施がどのように製品の品質と安全性に影響を与えるかを具体的に理解することができます。\u003C/p>\u003Ch3 id=\"hd637c934c8\">\u003Cstrong>成功事例：人工関節製造プロセスのバリデーション\u003C/strong>\u003C/h3>\u003Cp>A社は、高性能な人工股関節を製造する医療機器メーカーです。同社は、新しい製造ラインの導入に際して、徹底的な製造工程バリデーションを実施しました。\u003C/p>\u003Cp>バリデーションのプロセスは以下の手順で行われました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>プロセスデザインの検証：\u003C/strong>\u003Cul>\u003Cli>製造および品質管理プロセスの各段階（原材料の選択、成形、表面処理、滅菌、試験方法など）について詳細な分析を行いました。\u003C/li>\u003Cli>各工程の重要パラメータを特定し、許容範囲を設定しました。\u003C/li>\u003Cli>バリデーションによる品質保証が適切と考えられる設備・機器、工程を特定しました。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>設備の適格性評価：\u003C/strong>\u003Cul>\u003Cli>新規導入の製造設備について、設計時適格性評価（DQ）、設置時適格性評価（IQ）、運転時適格性評価（OQ）、性能適格性評価（PQ）を順次実施しました。\u003C/li>\u003Cli>特に、表面処理工程で使用する新型プラズマ装置については、処理条件の安定性を重点的に評価しました。\u003C/li>\u003Cli>トレーサビリティシステムでは、セキュリティ対策、誤操作、データの真正性、保管性を重点的に検証しました。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>プロセスバリデーション：\u003C/strong>\u003Cul>\u003Cli>実際の製造条件下で3ロットの検証バッチを製造し、製品の品質特性（寸法精度、表面粗さ、機械的強度など）を詳細に分析しました。\u003C/li>\u003Cli>統計的手法を用いて、製造プロセスの能力（Cpk値）が要求される1.33以上であることを確認しました。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>継続的プロセスベリフィケーション：\u003C/strong>\u003Cul>\u003Cli>製造開始後も、定期的にプロセスパラメータと製品品質のモニタリングを実施し、傾向分析並びに定期的バリデーションを行いました。\u003C/li>\u003Cli>6ヶ月ごとにデータレビューを行い、必要に応じてプロセスの最適化を図りました。\u003C/li>\u003Cli>製造環境および製造条件の変更を都度評価し、必要に応じて変更時のバリデーションを実施しました。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>この徹底したバリデーションの結果、A社は以下のような成果を得ることができました：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>製品不良率の大幅な低減（従来比50%減）\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>製造効率の向上（サイクルタイム20%短縮）\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>規制当局の査察での高評価獲得\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>市場シェアの拡大（2年間で15%増）\u003C/strong>\u003C/li>\u003C/ul>\u003Cp>A社の事例は、適切な製造工程バリデーションが製品品質の向上と企業の競争力強化に直結することを示しています。\u003C/p>\u003Ch3 id=\"h33349eb4aa\">\u003Cstrong>失敗事例：血糖測定器の製造プロセスにおけるバリデーション不足\u003C/strong>\u003C/h3>\u003Cp>一方、B社の事例は、バリデーションの不備がどのような結果をもたらすかを示す警鐘となっています。B社は、新型の血糖測定器を開発し、市場に投入しました。しかし、製品発売後まもなく、測定値の精度に関する苦情が多数寄せられるようになりました。\u003C/p>\u003Cp>調査の結果、以下の問題点が明らかになりました：\u003C/p>\u003Col>\u003Cli>\u003Cstrong>センサー部品の製造プロセスにおけるバリデーション不足：\u003C/strong>\u003Cul>\u003Cli>センサーの感度に直接影響を与える酵素コーティング工程のバリデーションが不十分でした。\u003C/li>\u003Cli>プロセスの変動要因（温度、湿度、コーティング時間など）の影響評価が適切に行われていませんでした。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>検査工程のバリデーション不備：\u003C/strong>\u003Cul>\u003Cli>最終検査で使用する標準液の管理が適切でなく、検査結果の信頼性が低下していました。\u003C/li>\u003Cli>検査装置の定期的な校正が行われておらず、経時的な精度低下を見逃していました。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>\u003Cstrong>製造環境のモニタリング不足：\u003C/strong>\u003Cul>\u003Cli>クリーンルーム内の微粒子や湿度の管理が不十分で、センサーの性能に影響を与えていました。\u003C/li>\u003Cli>製造工程の変更時にバリデーション要否を検討せずに工程変更を行った結果、重大な品質問題をおこしました。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの問題により、B社は以下のような深刻な影響を受けました：\u003C/p>\u003Cul>\u003Cli>\u003Cstrong>大規模な製品リコールの実施（約50万台）\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>多額の損害賠償の支払い\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>企業イメージの著しい低下\u003C/strong>\u003C/li>\u003Cli>\u003Cstrong>市場シェアの急激な減少（1年で30%減）\u003C/strong>\u003C/li>\u003C/ul>\u003Cp>B社の事例は、製造工程バリデーションの重要性を如実に示しています。適切なバリデーションを実施していれば、これらの問題の多くは製品出荷前に発見され、対策を講じることができたはずです。\u003C/p>\u003Cp>これらの成功事例と失敗事例は、製造工程バリデーションが単なる規制要件の遵守以上の意味を持つことを明確に示しています。適切なバリデーションは、製品の品質と安全性を確保するだけでなく、企業の評判と競争力を左右する重要な要素なのです。医療機器製造業者は、これらの事例から学び、自社の製造プロセスのバリデーションを継続的に改善していく必要があります。\u003C/p>\u003Ch2 id=\"h558eb86cf6\">\u003Cstrong>製造工程バリデーションの実施方法\u003C/strong>\u003C/h2>\u003Cp>製造工程バリデーションは、医療機器の品質と安全性を確保するための重要なプロセスです。適切に実施するためには、体系的なアプローチと十分な計画が必要です。以下に、製造工程バリデーションの実施方法について、わかりやすい始め方ガイドを提供します。\u003C/p>\u003Ch3 id=\"hbddfce931c\">\u003Cstrong>バリデーションの計画立案\u003C/strong>\u003C/h3>\u003Cp>バリデーションプロセスの最初のステップは、綿密な計画の立案です。この段階では以下の点に注意する必要があります：\u003C/p>\u003Col>\u003Cli>バリデーションチームの編成：\u003Cul>\u003Cli>品質保証、製造、エンジニアリング、設計開発等の部門から適切なメンバーを選出します。\u003C/li>\u003Cli>各メンバーの役割と責任を明確に定義します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>バリデーションマスタープランの作成：\u003Cul>\u003Cli>バリデーションの対象となるプロセスや設備を特定します。\u003C/li>\u003Cli>バリデーションの範囲、アプローチ、スケジュールを定義します。\u003C/li>\u003Cli>必要なリソースと予算を見積もります。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>リスク評価の実施：\u003Cul>\u003Cli>製造プロセスの各段階におけるリスクを特定し、評価します。\u003C/li>\u003Cli>リスクの重要度に基づいて、バリデーションの優先順位を決定します。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h97ee083661\">\u003Cstrong>プロトコルの作成\u003C/strong>\u003C/h3>\u003Cp>バリデーションプロトコルは、バリデーションの実施方法を詳細に記述した文書です。以下の要素を含める必要があります：\u003C/p>\u003Col>\u003Cli>バリデーションの目的と範囲\u003C/li>\u003Cli>責任者と実施者の明確化\u003C/li>\u003Cli>評価対象のプロセスや設備の詳細\u003C/li>\u003Cli>評価方法と判定基準\u003C/li>\u003Cli>サンプリング計画\u003C/li>\u003Cli>データ収集と分析方法\u003C/li>\u003Cli>手順からの逸脱時の対応手順\u003C/li>\u003C/ol>\u003Ch3 id=\"h4e3a1ae354\">\u003Cstrong>バリデーションの実施\u003C/strong>\u003C/h3>\u003Cp>実際のバリデーション作業は、通常以下の段階で行われます：\u003C/p>\u003Col>\u003Cli>設計時適格性評価（DQ）：\u003Cul>\u003Cli>製造設備や施設が要求事項を満たすよう適切に設計されているかを確認します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>設置時適格性評価（IQ）：\u003Cul>\u003Cli>設備が仕様通りに正しく設置されているかを確認します。\u003C/li>\u003Cli>必要な文書（操作マニュアル、保守手順書等）が整備されているかを確認します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>運転時適格性評価（OQ）：\u003Cul>\u003Cli>設備が意図した通りに動作するかを確認します。\u003C/li>\u003Cli>操作パラメータの許容範囲を決定します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>性能適格性評価（PQ）：\u003Cul>\u003Cli>バリデーション対象設備を実際の製造条件下で稼働させ、一貫して合格基準に適合する製品が製造できることを確認します。\u003C/li>\u003Cli>通常、最低3ロットの検証バッチを製造し評価します。\u003C/li>\u003Cli>PQはプロセスバリデーションを兼ねることも可能です。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>プロセスバリデーション（PV）：\u003Cul>\u003Cli>製造プロセス全体を、実際の製造条件下で、一貫して最終製品規格に適合する製品が製造できることを確認します。\u003C/li>\u003Cli>通常、本PVで合格しないと製品の出荷はできません。\u003C/li>\u003Cli>PVは性能適格性評価（PQ）を兼ねることができます。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h8b74e01caa\">\u003Cstrong>データの分析と報告書の作成\u003C/strong>\u003C/h3>\u003Cp>バリデーション作業が完了したら、収集したデータを分析し、結果を報告書にまとめます。報告書には以下の内容を含める必要があります：\u003C/p>\u003Col>\u003Cli>バリデーションの概要\u003C/li>\u003Cli>使用した設備、機器、原材料の詳細\u003C/li>\u003Cli>実施したテストと結果の詳細\u003C/li>\u003Cli>データ分析結果と統計的評価\u003C/li>\u003Cli>判定基準に対する適合性の評価\u003C/li>\u003Cli>発生した逸脱事項とその対応\u003C/li>\u003Cli>結論と推奨事項\u003C/li>\u003C/ol>\u003Ch3 id=\"h9fa49ad87d\">\u003Cstrong>バリデーションの維持と再バリデーション\u003C/strong>\u003C/h3>\u003Cp>バリデーションは一度実施すれば終わりではありません。以下の活動を通じて、バリデーションの状態を維持する必要があります：\u003C/p>\u003Col>\u003Cli>定期的なプロセスモニタリング\u003C/li>\u003Cli>変更管理の実施（プロセスや設備の変更時には再バリデーションの要否を評価）\u003C/li>\u003Cli>定期的な再バリデーションの実施（通常、1-3年ごと）\u003C/li>\u003C/ol>\u003Ch3 id=\"h222b065b3a\">\u003Cstrong>必要な資料やリソース\u003C/strong>\u003C/h3>\u003Cp>製造工程バリデーションを適切に実施するためには、以下のような資料やリソースが必要となります：\u003C/p>\u003Col>\u003Cli>規制要件に関する文書：\u003Cul>\u003Cli>医薬品医療機器等法（旧薬事法）\u003C/li>\u003Cli>QMS省令（医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令）\u003C/li>\u003Cli>（必要に応じて）滅菌バリデーション基準\u003C/li>\u003Cli>（必要に応じて）FDA 21 CFR Part 820（品質システム規則）\u003C/li>\u003Cli>（必要に応じて）ISO 13485（医療機器の品質マネジメントシステム）\u003C/li>\u003C/ul>\u003C/li>\u003Cli>ガイドライン：\u003Cul>\u003Cli>厚生労働省「医療機器製造販売業者等における製造管理及び品質管理に関する基準（QMS）について」\u003C/li>\u003Cli>FDA「Process Validation: General Principles and Practices」\u003C/li>\u003Cli>ISO/TR 80002-2　Medical device software – Part 2：Validation of software for medical device quality system\u003C/li>\u003Cli>医薬品・医薬部外品製造販売業者等におけるコンピューター化システム適正管理ガイドライン\u003C/li>\u003C/ul>\u003C/li>\u003Cli>標準作業手順書（SOP）：\u003Cul>\u003Cli>バリデーションマスタープラン作成手順\u003C/li>\u003Cli>プロトコル作成手順\u003C/li>\u003Cli>データ分析手順\u003C/li>\u003Cli>報告書作成手順\u003C/li>\u003C/ul>\u003C/li>\u003Cli>テンプレート：\u003Cul>\u003Cli>バリデーションマスタープラン\u003C/li>\u003Cli>バリデーションプロトコル\u003C/li>\u003Cli>バリデーション報告書\u003C/li>\u003C/ul>\u003C/li>\u003Cli>トレーニング資料：\u003Cul>\u003Cli>バリデーションの基礎知識\u003C/li>\u003Cli>統計的手法の使用方法\u003C/li>\u003Cli>データ解析ツールの使用方法\u003C/li>\u003C/ul>\u003C/li>\u003Cli>ソフトウェアツール：\u003Cul>\u003Cli>統計解析ソフトウェア（例：Minitab、JMP）\u003C/li>\u003Cli>プロジェクト管理ツール\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの資料やリソースを適切に活用することで、効果的かつ効率的な製造工程バリデーションの実施が可能となります。特に、規制要件やガイドラインの最新版を常に参照し、業界のベストプラクティスに沿ったバリデーションを行うことが重要です。\u003C/p>\u003Cp>製造工程バリデーションは複雑で時間のかかるプロセスですが、製品の品質と安全性を確保するために不可欠な活動です。上記のステップを丁寧に実施し、必要な資料やリソースを活用することで、効果的なバリデーションを実現することができます。\u003C/p>\u003Ch2 id=\"h9fbff33e7e\">\u003Cstrong>製造工程バリデーションの効果的な運用方法\u003C/strong>\u003C/h2>\u003Cp>製造工程バリデーションを効果的に運用するためには、単にバリデーションを実施するだけでなく、継続的なモニタリングと評価、そして改善活動が必要です。以下に、効果的な運用方法とよくある課題への対応について説明します。\u003C/p>\u003Ch3 id=\"hb9e8ff209f\">\u003Cstrong>モニタリングと評価方法\u003C/strong>\u003C/h3>\u003Col>\u003Cli>継続的プロセスベリフィケーション（CPV）の実施：\u003Cul>\u003Cli>重要品質特性（CQA）と重要プロセスパラメータ（CPP）を定期的にモニタリングします。\u003C/li>\u003Cli>統計的プロセス管理（SPC）を用いて、プロセスの安定性と能力を評価します。\u003C/li>\u003Cli>トレンド分析を行い、プロセスの変動や劣化の兆候を早期に検出します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>品質指標（KQI）の設定と監視：\u003Cul>\u003Cli>製品品質、プロセス性能などに関する重要な指標を設定します。\u003C/li>\u003Cli>これらの指標を定期的に測定し、目標値との乖離を評価します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>定期的なレビューの実施：\u003Cul>\u003Cli>年次または四半期ごとに、バリデーション状態のレビューを行います。\u003C/li>\u003Cli>年次のプロダクトクオリティレビュー（PQR）を通じて、製品とプロセス全体の性能を評価します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>変更管理システムの運用：\u003Cul>\u003Cli>プロセス、設備、原材料などの変更を厳密に管理します。\u003C/li>\u003Cli>変更の影響を評価し、必要に応じて再バリデーションを実施します。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>逸脱管理と是正措置・予防措置（CAPA）システムの活用：\u003Cul>\u003Cli>バリデーション済みプロセスからの逸脱を適切に記録、調査、対応します。\u003C/li>\u003Cli>根本原因分析を行い、再発防止策を実施します。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Ch3 id=\"h9a14abed27\">\u003Cstrong>よくある課題とその対応方法\u003C/strong>\u003C/h3>\u003Col>\u003Cli>リソースの不足： 課題：バリデーション活動に十分な人員や予算が割り当てられない。 対応：\u003Cul>\u003Cli>バリデーションの重要性と投資効果を経営層に説明し、理解を得る。\u003C/li>\u003Cli>リスクアプローチを採用し、重要度の高いプロセスに資源を集中させる。\u003C/li>\u003Cli>外部コンサルタントの活用や自動化ツールの導入で効率的なバリデーション手段を検討する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>過剰なバリデーション： 課題：必要以上に詳細なバリデーションを行い、時間とコストが膨らむ。 対応：\u003Cul>\u003Cli>リスク評価に基づいて、バリデーションの範囲と深さを適切に設定する。\u003C/li>\u003Cli>簡略化バリデーション手法（例：同時性バリデーション）の適用を検討する。\u003C/li>\u003Cli>バリデーション活動の効率を定期的に評価し、改善する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>データの信頼性と完全性の確保： 課題：データの収集、管理、分析における信頼性や完全性に問題が生じる。 対応：\u003Cul>\u003Cli>データインテグリティに関する教育訓練を強化する。\u003C/li>\u003Cli>電子記録システムを導入し、監査証跡を確保する。\u003C/li>\u003Cli>定期的なデータレビューとチェックを実施する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>複雑な製造プロセスへの対応： 課題：複雑な製造プロセスや新技術の導入時に、適切なバリデーション方法の確立が困難。 対応：\u003Cul>\u003Cli>プロセス分析技術（PAT）の導入を検討し、リアルタイムでのプロセス理解を深める。\u003C/li>\u003Cli>シミュレーション技術やデザインスペースの概念を活用し、プロセスの挙動を予測する。\u003C/li>\u003Cli>専門家や規制当局との事前相談を行い、適切なバリデーションアプローチを確認する。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>規制要件の変更への対応： 課題：規制要件の変更に伴い、既存のバリデーション方法の見直しが必要となる。 対応：\u003Cul>\u003Cli>規制動向の継続的な監視と、社内への迅速な情報共有を行う。\u003C/li>\u003Cli>規制の変更が予定されている場合は、事前に影響評価と対応計画を立案する。\u003C/li>\u003Cli>柔軟性のあるバリデーション戦略を採用し、変更に対応しやすい体制を整える。\u003C/li>\u003C/ul>\u003C/li>\u003Cli>サプライヤーの管理： 課題：原材料や部品のサプライヤーの製造プロセスのバリデーション状況の把握が困難。 対応：\u003Cul>\u003Cli>サプライヤー監査プログラムを強化し、定期的な評価を実施する。\u003C/li>\u003Cli>重要な原材料や部品については、サプライヤーとの品質契約を締結し、バリデーション要件を明確化する。\u003C/li>\u003Cli>サプライヤーの変更管理プロセスを確認し、必要に応じて再バリデーションを要求する。\u003C/li>\u003C/ul>\u003C/li>\u003C/ol>\u003Cp>これらの課題に適切に対応することで、製造工程バリデーションの効果的な運用が可能となります。重要なのは、バリデーションを単なる規制要件の遵守としてではなく、製品品質の向上と製造プロセスの最適化のためのツールとして活用することです。\u003C/p>\u003Cp>継続的な改善の姿勢を持ち、最新の技術や手法を積極的に取り入れながら、効率的かつ効果的なバリデーション活動を展開していくことが、医療機器製造業者には求められています。\u003C/p>\u003Ch2 id=\"ha214098e44\">\u003Cstrong>まとめ\u003C/strong>\u003C/h2>\u003Cp>製造工程バリデーションは、医療機器の製造管理において不可欠な要素です。本記事では、その定義、必要性、実施方法、および効果的な運用方法について詳しく解説しました。\u003C/p>\u003Cp>適切なバリデーションの実施は、製品品質の一貫性確保、リスク低減、効率性の向上、そして顧客信頼の獲得につながります。一方で、リソース不足や複雑なプロセスへの対応など、様々な課題も存在します。\u003C/p>\u003Cp>製造工程バリデーションは単なる規制要件の遵守ではなく、製品の品質と安全性を確保し、企業の競争力を高めるための戦略的ツールです。継続的な改善と最適化に取り組むことで、高品質で安全な医療機器の安定供給が可能となり、患者のQOL向上と医療の発展に貢献できるのです。\u003C/p>\u003Cp>医療機器製造業者は、技術の進歩や規制環境の変化に柔軟に対応しながら、常に最適なバリデーション手法を追求し続けることが求められています。\u003C/p>",{"url":173,"height":174,"width":13},"https://images.microcms-assets.io/assets/f66dcbcc145648f88aa317fc3a705f91/5486a1affd294c9a9806e53ca360e7d3/sekkei-min.webp",844,"QMSにおける製造工程バリデーションは医療機器の品質と安全性を保証する重要プロセス。定義、必要性、実施方法、効果的運用を解説。成功例と失敗例から学ぶ重要性と、よくある課題への対応策を紹介。医療機器メーカー必見の総合ガイド。",{"id":16,"createdAt":17,"updatedAt":18,"publishedAt":17,"revisedAt":18,"name":19,"image":177,"profile":24,"subtitle":25,"profile_url":26,"profile_sameas_url":27},{"url":21,"height":22,"width":23},[179,180],{"id":82,"createdAt":83,"updatedAt":83,"publishedAt":83,"revisedAt":83,"name":84},{"id":30,"createdAt":31,"updatedAt":32,"publishedAt":31,"revisedAt":32,"name":33},{"device":182,"deviceItems":208,"recalls":272,"allStatsData":273},{"id":183,"class_notification":184,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":189,"generic_name":190,"generic_name_definition":191,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":199,"growth_ratio":200,"average_price":201,"domestic_ratio":202,"product_count":203,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},324,"1-0324",null,"医04","整形用品","その他の歯科材料","34006004","吸収性歯科用骨再建インプラント材","顎骨内の欠損部を満たしたり(充填)、顎骨の築盛(補強)のための歯科治療に用いる吸収性の生体材料をいう。","Ⅳ","8-⑤","－","209904002","歯科用インプラント材","Ⅲ",true,4.94,3.79,1.51,100,9,6,"億円/年","万円/個","2025-03-24T01:34:40.770687+00:00",[209,216,224,233,240,247,254,261,264,268],{"id":210,"approval_date":185,"approval_number":211,"approval_category":212,"product_name":213,"medical_device_id":183,"company_name":214,"generic_name":190,"device_category":215,"memo":185,"approval_month":185},290603,"22400BZX00002000","承認","セラソルブM","ジンヴィ・ジャパン合同会社","承認品目",{"id":217,"approval_date":218,"approval_number":219,"approval_category":212,"product_name":220,"medical_device_id":183,"company_name":221,"generic_name":190,"device_category":222,"memo":185,"approval_month":223},116692,"2024-07-04","30600BZI00014000","メガジェン　Ｂｏｎｅ　Ｍａｔｒｉｘ\u003Chka>わん\u003C/hka>","ＭｅｇａＧｅｎ　Ｉｍｐｌａｎｔ　Ｃｏ．，Ｌｔｄ","改良医療機器（臨床なし）","2024-07-01",{"id":225,"approval_date":226,"approval_number":227,"approval_category":228,"product_name":229,"medical_device_id":183,"company_name":230,"generic_name":190,"device_category":231,"memo":185,"approval_month":232},50329,"2022-02-15","22900BZX00406000","一変","ジーシー　サイトランス　グラニュール","株式会社ジーシー","後発医療機器","2022-02-01",{"id":234,"approval_date":235,"approval_number":236,"approval_category":212,"product_name":237,"medical_device_id":183,"company_name":238,"generic_name":190,"device_category":222,"memo":185,"approval_month":239},79594,"2021-08-12","30300BZX00228000","ＧＲタックピン","帝人メディカルテクノロジー株式会社","2021-08-01",{"id":241,"approval_date":242,"approval_number":243,"approval_category":244,"product_name":245,"medical_device_id":183,"company_name":230,"generic_name":190,"device_category":222,"memo":185,"approval_month":246},79968,"2020-05-26","30200BZX00173000","新規","ジーシー　サイトランス　エラシールド","2020-05-01",{"id":248,"approval_date":249,"approval_number":250,"approval_category":228,"product_name":251,"medical_device_id":183,"company_name":252,"generic_name":190,"device_category":231,"memo":185,"approval_month":253},87113,"2018-05-15","22700BZX00221000","オスフェリオン　ＤＥＮＴＡＬ","オリンパステルモバイオマテリアル株式会社","2018-05-01",{"id":255,"approval_date":256,"approval_number":257,"approval_category":244,"product_name":258,"medical_device_id":183,"company_name":259,"generic_name":190,"device_category":231,"memo":185,"approval_month":260},54455,"2017-12-15","22900BZX00411000","ＰＬＡＴＯＮパールボーン","株式会社カタリメディック","2017-12-01",{"id":262,"approval_date":260,"approval_number":227,"approval_category":212,"product_name":263,"medical_device_id":183,"company_name":230,"generic_name":190,"device_category":215,"memo":185,"approval_month":260},336526,"ジーシー サイトランス グラニュール",{"id":265,"approval_date":266,"approval_number":250,"approval_category":228,"product_name":251,"medical_device_id":183,"company_name":252,"generic_name":190,"device_category":231,"memo":185,"approval_month":267},52613,"2017-10-20","2017-10-01",{"id":269,"approval_date":270,"approval_number":250,"approval_category":212,"product_name":271,"medical_device_id":183,"company_name":252,"generic_name":190,"device_category":215,"memo":185,"approval_month":270},265342,"2015-08-01","オスフェリオン DENTAL",[],[274,1943],{"stat":275,"timeList":287,"groupedData":372},{"id":276,"table_id":277,"table_name":278,"stats_name":279,"updated_date":280,"stats_items":281},5,"000031858705","医療機器一般的名称別生産・輸入・出荷・月末在庫数量","月報 薬事工業生産動態統計調査 統計表","2024-08-24",[282],{"id":283,"code":189,"name":284,"unit":285,"level":286,"stats_id":276,"parent_item_id":185,"parent_item_code":186},1934,"34006004_吸収性歯科用骨再建インプラント材","個",3,[288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371],"201901","201902","201903","201904","201905","201906","201907","201908","201909","201910","201911","201912","202001","202002","202003","202004","202005","202006","202007","202008","202009","202010","202011","202012","202101","202102","202103","202104","202105","202106","202107","202108","202109","202110","202111","202112","202201","202202","202203","202204","202205","202206","202207","202208","202209","202210","202211","202212","202301","202302","202303","202304","202305","202306","202307","202308","202309","202310","202311","202312","202401","202402","202403","202404","202405","202406","202407","202408","202409","202410","202411","202412","202501","202502","202503","202504","202505","202506","202507","202508","202509","202510","202511","202512",[373,716,902,1088,1687],{"code2_name":374,"code2":375,"items":376},"計","cat02_10",[377],{"code1_name":374,"code1":378,"data":379},"cat01_10",{"201901":380,"201902":384,"201903":388,"201904":392,"201905":396,"201906":400,"201907":404,"201908":408,"201909":412,"201910":416,"201911":420,"201912":424,"202001":428,"202002":432,"202003":436,"202004":440,"202005":444,"202006":448,"202007":452,"202008":456,"202009":460,"202010":464,"202011":468,"202012":472,"202101":476,"202102":480,"202103":484,"202104":488,"202105":492,"202106":496,"202107":500,"202108":504,"202109":508,"202110":512,"202111":516,"202112":520,"202201":524,"202202":528,"202203":532,"202204":536,"202205":540,"202206":544,"202207":548,"202208":552,"202209":556,"202210":560,"202211":564,"202212":568,"202301":572,"202302":576,"202303":580,"202304":584,"202305":588,"202306":592,"202307":596,"202308":600,"202309":604,"202310":608,"202311":612,"202312":616,"202401":620,"202402":624,"202403":628,"202404":632,"202405":636,"202406":640,"202407":644,"202408":648,"202409":652,"202410":656,"202411":660,"202412":664,"202501":668,"202502":672,"202503":676,"202504":680,"202505":684,"202506":688,"202507":692,"202508":696,"202509":700,"202510":704,"202511":708,"202512":712},{"id":381,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":288,"unit":285,"count":382,"stats_id":276,"stats_item_id":283,"inserted_at":383},442605,177,"2024-08-28T23:36:32.244021+00:00",{"id":385,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":289,"unit":285,"count":386,"stats_id":276,"stats_item_id":283,"inserted_at":387},455774,809,"2024-08-29T14:28:12.488232+00:00",{"id":389,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":290,"unit":285,"count":390,"stats_id":276,"stats_item_id":283,"inserted_at":391},468038,1516,"2024-08-29T14:28:47.19889+00:00",{"id":393,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":291,"unit":285,"count":394,"stats_id":276,"stats_item_id":283,"inserted_at":395},480330,2457,"2024-08-29T14:28:52.124057+00:00",{"id":397,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":292,"unit":285,"count":398,"stats_id":276,"stats_item_id":283,"inserted_at":399},492594,2402,"2024-08-29T14:28:56.209871+00:00",{"id":401,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":293,"unit":285,"count":402,"stats_id":276,"stats_item_id":283,"inserted_at":403},504872,1504,"2024-08-29T14:28:59.965502+00:00",{"id":405,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":294,"unit":285,"count":406,"stats_id":276,"stats_item_id":283,"inserted_at":407},517220,1066,"2024-08-29T14:29:03.391272+00:00",{"id":409,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":295,"unit":285,"count":410,"stats_id":276,"stats_item_id":283,"inserted_at":411},529624,599,"2024-08-29T14:29:07.620926+00:00",{"id":413,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":296,"unit":285,"count":414,"stats_id":276,"stats_item_id":283,"inserted_at":415},541986,1665,"2024-08-29T14:29:10.942107+00:00",{"id":417,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":297,"unit":285,"count":418,"stats_id":276,"stats_item_id":283,"inserted_at":419},554376,975,"2024-08-29T14:29:15.001907+00:00",{"id":421,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":298,"unit":285,"count":422,"stats_id":276,"stats_item_id":283,"inserted_at":423},579086,2054,"2024-08-29T14:29:21.361833+00:00",{"id":425,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":299,"unit":285,"count":426,"stats_id":276,"stats_item_id":283,"inserted_at":427},591322,748,"2024-08-29T14:29:24.372047+00:00",{"id":429,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":300,"unit":285,"count":430,"stats_id":276,"stats_item_id":283,"inserted_at":431},786398,1044,"2024-08-29T15:50:38.294917+00:00",{"id":433,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":301,"unit":285,"count":434,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118261,1400,"2024-08-29T16:01:48.934151+00:00",{"id":437,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":302,"unit":285,"count":438,"stats_id":276,"stats_item_id":283,"inserted_at":439},798627,1833,"2024-08-29T15:51:22.755318+00:00",{"id":441,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":303,"unit":285,"count":442,"stats_id":276,"stats_item_id":283,"inserted_at":443},809925,2365,"2024-08-29T15:51:30.337125+00:00",{"id":445,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":304,"unit":285,"count":446,"stats_id":276,"stats_item_id":283,"inserted_at":447},822301,50,"2024-08-29T15:51:37.125871+00:00",{"id":449,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":305,"unit":285,"count":450,"stats_id":276,"stats_item_id":283,"inserted_at":451},834600,1966,"2024-08-29T15:51:44.021373+00:00",{"id":453,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":306,"unit":285,"count":454,"stats_id":276,"stats_item_id":283,"inserted_at":455},846990,111,"2024-08-29T15:51:49.757573+00:00",{"id":457,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":307,"unit":285,"count":458,"stats_id":276,"stats_item_id":283,"inserted_at":459},859429,1456,"2024-08-29T15:51:55.839839+00:00",{"id":461,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":308,"unit":285,"count":462,"stats_id":276,"stats_item_id":283,"inserted_at":463},871847,868,"2024-08-29T15:52:02.309873+00:00",{"id":465,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":309,"unit":285,"count":466,"stats_id":276,"stats_item_id":283,"inserted_at":467},884363,2382,"2024-08-29T15:52:07.062967+00:00",{"id":469,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":310,"unit":285,"count":470,"stats_id":276,"stats_item_id":283,"inserted_at":471},896732,2346,"2024-08-29T15:52:12.239798+00:00",{"id":473,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":311,"unit":285,"count":474,"stats_id":276,"stats_item_id":283,"inserted_at":475},909115,1291,"2024-08-29T15:52:17.000525+00:00",{"id":477,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":312,"unit":285,"count":478,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400704,1737,"2024-08-29T16:34:24.512514+00:00",{"id":481,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":313,"unit":285,"count":482,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412940,577,"2024-08-29T16:34:31.056176+00:00",{"id":485,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":314,"unit":285,"count":486,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425435,3803,"2024-08-29T16:34:36.56788+00:00",{"id":489,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":315,"unit":285,"count":490,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438028,2367,"2024-08-29T16:34:41.363507+00:00",{"id":493,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":316,"unit":285,"count":494,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450474,3121,"2024-08-29T16:34:46.018717+00:00",{"id":497,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":317,"unit":285,"count":498,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462759,2011,"2024-08-29T16:34:50.241244+00:00",{"id":501,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":318,"unit":285,"count":502,"stats_id":276,"stats_item_id":283,"inserted_at":503},1474995,3112,"2024-08-29T16:34:56.336902+00:00",{"id":505,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":319,"unit":285,"count":506,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487357,2122,"2024-08-29T16:35:03.162823+00:00",{"id":509,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":320,"unit":285,"count":510,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499747,4048,"2024-08-29T16:35:39.563249+00:00",{"id":513,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":321,"unit":285,"count":514,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512242,3029,"2024-08-29T16:35:48.24299+00:00",{"id":517,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":322,"unit":285,"count":518,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524569,5054,"2024-08-29T16:35:52.778166+00:00",{"id":521,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":323,"unit":285,"count":522,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536945,4721,"2024-08-29T16:35:57.945574+00:00",{"id":525,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":324,"unit":285,"count":526,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848487,4575,"2024-08-29T16:54:20.496663+00:00",{"id":529,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":325,"unit":285,"count":530,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836160,3576,"2024-08-29T16:54:16.535405+00:00",{"id":533,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":326,"unit":285,"count":534,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823686,1521,"2024-08-29T16:54:12.672457+00:00",{"id":537,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":327,"unit":285,"count":538,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811163,1061,"2024-08-29T16:54:09.326413+00:00",{"id":541,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":328,"unit":285,"count":542,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798605,1669,"2024-08-29T16:54:04.657607+00:00",{"id":545,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":329,"unit":285,"count":546,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786075,2121,"2024-08-29T16:54:01.671375+00:00",{"id":549,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":330,"unit":285,"count":550,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773517,2681,"2024-08-29T16:53:57.921049+00:00",{"id":553,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":331,"unit":285,"count":554,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761022,4222,"2024-08-29T16:53:54.051194+00:00",{"id":557,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":332,"unit":285,"count":558,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748373,2141,"2024-08-29T16:53:50.446784+00:00",{"id":561,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":333,"unit":285,"count":562,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723138,2795,"2024-08-29T16:53:39.634291+00:00",{"id":565,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":334,"unit":285,"count":566,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710552,3356,"2024-08-29T16:53:36.213005+00:00",{"id":569,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":335,"unit":285,"count":570,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697903,2662,"2024-08-29T16:53:31.519747+00:00",{"id":573,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":336,"unit":285,"count":574,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152105,3821,"2024-08-29T18:30:57.35995+00:00",{"id":577,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":337,"unit":285,"count":578,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139407,2351,"2024-08-29T18:30:53.142822+00:00",{"id":581,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":338,"unit":285,"count":582,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126681,293,"2024-08-29T18:30:48.943+00:00",{"id":585,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":339,"unit":285,"count":586,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113948,1254,"2024-08-29T18:30:44.055463+00:00",{"id":589,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":340,"unit":285,"count":590,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101292,1711,"2024-08-29T18:30:40.665562+00:00",{"id":593,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":341,"unit":285,"count":594,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088503,2634,"2024-08-29T18:30:32.166153+00:00",{"id":597,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":342,"unit":285,"count":598,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075700,2,"2024-08-29T18:30:28.119299+00:00",{"id":601,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":343,"unit":285,"count":602,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062953,1839,"2024-08-29T18:30:24.088277+00:00",{"id":605,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":344,"unit":285,"count":606,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050143,2575,"2024-08-29T18:30:18.722148+00:00",{"id":609,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":345,"unit":285,"count":610,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037354,45,"2024-08-29T18:30:14.807285+00:00",{"id":613,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":346,"unit":285,"count":614,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024558,1724,"2024-08-29T18:30:10.802048+00:00",{"id":617,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":347,"unit":285,"count":618,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011692,1842,"2024-08-29T18:29:38.314702+00:00",{"id":621,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":348,"unit":285,"count":622,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381922,1740,"2024-08-29T18:41:03.997623+00:00",{"id":625,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":349,"unit":285,"count":626,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394690,3623,"2024-08-29T18:41:08.980432+00:00",{"id":629,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":350,"unit":285,"count":630,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407472,2913,"2024-08-29T18:41:14.524512+00:00",{"id":633,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":351,"unit":285,"count":634,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420247,2912,"2024-08-29T18:41:19.041713+00:00",{"id":637,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":352,"unit":285,"count":638,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433043,1758,"2024-08-29T18:41:27.562738+00:00",{"id":641,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":353,"unit":285,"count":642,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535159,1236,"2024-09-19T17:06:01.620973+00:00",{"id":645,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":354,"unit":285,"count":646,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611550,4552,"2024-10-14T19:25:38.341637+00:00",{"id":649,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":355,"unit":285,"count":650,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698917,3277,"2024-11-15T11:59:57.395937+00:00",{"id":653,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":356,"unit":285,"count":654,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724320,1174,"2024-12-13T11:12:07.886797+00:00",{"id":657,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":357,"unit":285,"count":658,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749730,3868,"2025-01-14T11:40:34.02754+00:00",{"id":661,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":358,"unit":285,"count":662,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775266,3027,"2025-02-14T14:29:46.378617+00:00",{"id":665,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":359,"unit":285,"count":666,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801005,2192,"2025-03-14T18:58:14.781071+00:00",{"id":669,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":360,"unit":285,"count":670,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826562,3491,"2025-04-18T11:30:06.359073+00:00",{"id":673,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":361,"unit":285,"count":674,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852007,3592,"2025-05-16T12:13:58.669968+00:00",{"id":677,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":362,"unit":285,"count":678,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877557,3326,"2025-06-14T01:41:04.249725+00:00",{"id":681,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":363,"unit":285,"count":682,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903023,2625,"2025-07-14T19:06:31.393556+00:00",{"id":685,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":364,"unit":285,"count":686,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928286,2753,"2025-08-16T12:24:46.126079+00:00",{"id":689,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":365,"unit":285,"count":690,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953584,1000,"2025-09-12T11:42:16.469967+00:00",{"id":693,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":366,"unit":285,"count":694,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979155,2333,"2025-10-14T11:42:40.643159+00:00",{"id":697,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":367,"unit":285,"count":698,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004593,5666,"2025-11-14T12:41:50.840033+00:00",{"id":701,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":368,"unit":285,"count":702,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030031,2206,"2025-12-12T11:35:03.870889+00:00",{"id":705,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":369,"unit":285,"count":706,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055385,1329,"2026-01-16T14:45:56.901655+00:00",{"id":709,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":370,"unit":285,"count":710,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080900,1974,"2026-02-16T12:05:47.421276+00:00",{"id":713,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":371,"unit":285,"count":714,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106338,3199,"2026-03-16T13:31:19.912177+00:00",{"code2_name":717,"code2":718,"items":719},"生産","cat02_20",[720],{"code1_name":374,"code1":378,"data":721},{"201901":722,"201902":724,"201903":727,"201904":729,"201905":732,"201906":734,"201907":736,"201908":738,"201909":741,"201910":744,"201911":746,"201912":749,"202001":751,"202002":753,"202003":756,"202004":758,"202005":760,"202006":762,"202007":765,"202008":767,"202009":770,"202010":772,"202011":774,"202012":777,"202101":780,"202102":782,"202103":784,"202104":786,"202105":788,"202106":790,"202107":793,"202108":796,"202109":798,"202110":800,"202111":802,"202112":804,"202201":806,"202202":808,"202203":810,"202204":812,"202205":814,"202206":816,"202207":818,"202208":820,"202209":822,"202210":824,"202211":826,"202212":828,"202301":830,"202302":832,"202303":834,"202304":836,"202305":838,"202306":840,"202307":842,"202308":844,"202309":846,"202310":848,"202311":850,"202312":852,"202401":854,"202402":856,"202403":858,"202404":860,"202405":862,"202406":864,"202407":866,"202408":868,"202409":870,"202410":872,"202411":874,"202412":876,"202501":878,"202502":880,"202503":882,"202504":884,"202505":886,"202506":888,"202507":890,"202508":892,"202509":894,"202510":896,"202511":898,"202512":900},{"id":723,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":288,"unit":285,"count":382,"stats_id":276,"stats_item_id":283,"inserted_at":383},442606,{"id":725,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":289,"unit":285,"count":726,"stats_id":276,"stats_item_id":283,"inserted_at":387},455775,729,{"id":728,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":290,"unit":285,"count":390,"stats_id":276,"stats_item_id":283,"inserted_at":391},468039,{"id":730,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":291,"unit":285,"count":731,"stats_id":276,"stats_item_id":283,"inserted_at":395},480331,1187,{"id":733,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":292,"unit":285,"count":398,"stats_id":276,"stats_item_id":283,"inserted_at":399},492595,{"id":735,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":293,"unit":285,"count":402,"stats_id":276,"stats_item_id":283,"inserted_at":403},504873,{"id":737,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":294,"unit":285,"count":406,"stats_id":276,"stats_item_id":283,"inserted_at":407},517221,{"id":739,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":295,"unit":285,"count":740,"stats_id":276,"stats_item_id":283,"inserted_at":411},529625,598,{"id":742,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":296,"unit":285,"count":743,"stats_id":276,"stats_item_id":283,"inserted_at":415},541987,565,{"id":745,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":297,"unit":285,"count":418,"stats_id":276,"stats_item_id":283,"inserted_at":419},554377,{"id":747,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":298,"unit":285,"count":748,"stats_id":276,"stats_item_id":283,"inserted_at":423},579087,1474,{"id":750,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":299,"unit":285,"count":426,"stats_id":276,"stats_item_id":283,"inserted_at":427},591323,{"id":752,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":300,"unit":285,"count":430,"stats_id":276,"stats_item_id":283,"inserted_at":431},786399,{"id":754,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":301,"unit":285,"count":755,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118262,900,{"id":757,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":302,"unit":285,"count":438,"stats_id":276,"stats_item_id":283,"inserted_at":439},798628,{"id":759,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":303,"unit":285,"count":442,"stats_id":276,"stats_item_id":283,"inserted_at":443},809926,{"id":761,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":304,"unit":285,"count":446,"stats_id":276,"stats_item_id":283,"inserted_at":447},822302,{"id":763,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":305,"unit":285,"count":764,"stats_id":276,"stats_item_id":283,"inserted_at":451},834601,1046,{"id":766,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":306,"unit":285,"count":454,"stats_id":276,"stats_item_id":283,"inserted_at":455},846991,{"id":768,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":307,"unit":285,"count":769,"stats_id":276,"stats_item_id":283,"inserted_at":459},859430,1216,{"id":771,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":308,"unit":285,"count":462,"stats_id":276,"stats_item_id":283,"inserted_at":463},871848,{"id":773,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":309,"unit":285,"count":466,"stats_id":276,"stats_item_id":283,"inserted_at":467},884364,{"id":775,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":310,"unit":285,"count":776,"stats_id":276,"stats_item_id":283,"inserted_at":471},896733,1856,{"id":778,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":311,"unit":285,"count":779,"stats_id":276,"stats_item_id":283,"inserted_at":475},909116,536,{"id":781,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":312,"unit":285,"count":478,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400705,{"id":783,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":313,"unit":285,"count":482,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412941,{"id":785,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":314,"unit":285,"count":486,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425436,{"id":787,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":315,"unit":285,"count":490,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438029,{"id":789,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":316,"unit":285,"count":494,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450475,{"id":791,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":317,"unit":285,"count":792,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462760,1411,{"id":794,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":318,"unit":285,"count":795,"stats_id":276,"stats_item_id":283,"inserted_at":503},1474996,2900,{"id":797,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":319,"unit":285,"count":506,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487358,{"id":799,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":320,"unit":285,"count":510,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499748,{"id":801,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":321,"unit":285,"count":514,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512243,{"id":803,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":322,"unit":285,"count":518,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524570,{"id":805,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":323,"unit":285,"count":522,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536946,{"id":807,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":324,"unit":285,"count":526,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848488,{"id":809,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":325,"unit":285,"count":530,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836161,{"id":811,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":326,"unit":285,"count":534,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823687,{"id":813,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":327,"unit":285,"count":538,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811164,{"id":815,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":328,"unit":285,"count":542,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798606,{"id":817,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":329,"unit":285,"count":546,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786076,{"id":819,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":330,"unit":285,"count":550,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773518,{"id":821,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":331,"unit":285,"count":554,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761023,{"id":823,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":332,"unit":285,"count":558,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748374,{"id":825,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":333,"unit":285,"count":562,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723139,{"id":827,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":334,"unit":285,"count":566,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710553,{"id":829,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":335,"unit":285,"count":570,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697904,{"id":831,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":336,"unit":285,"count":574,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152106,{"id":833,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":337,"unit":285,"count":578,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139408,{"id":835,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":338,"unit":285,"count":582,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126682,{"id":837,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":339,"unit":285,"count":586,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113949,{"id":839,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":340,"unit":285,"count":590,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101293,{"id":841,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":341,"unit":285,"count":594,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088504,{"id":843,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":342,"unit":285,"count":598,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075701,{"id":845,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":343,"unit":285,"count":602,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062954,{"id":847,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":344,"unit":285,"count":606,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050144,{"id":849,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":345,"unit":285,"count":610,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037355,{"id":851,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":346,"unit":285,"count":614,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024559,{"id":853,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":347,"unit":285,"count":618,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011693,{"id":855,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":348,"unit":285,"count":622,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381923,{"id":857,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":349,"unit":285,"count":626,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394691,{"id":859,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":350,"unit":285,"count":630,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407473,{"id":861,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":351,"unit":285,"count":634,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420248,{"id":863,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":352,"unit":285,"count":638,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433044,{"id":865,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":353,"unit":285,"count":642,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535160,{"id":867,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":354,"unit":285,"count":646,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611551,{"id":869,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":355,"unit":285,"count":650,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698918,{"id":871,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":356,"unit":285,"count":654,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724321,{"id":873,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":357,"unit":285,"count":658,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749731,{"id":875,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":358,"unit":285,"count":662,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775267,{"id":877,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":359,"unit":285,"count":666,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801006,{"id":879,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":360,"unit":285,"count":670,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826563,{"id":881,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":361,"unit":285,"count":674,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852008,{"id":883,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":362,"unit":285,"count":678,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877558,{"id":885,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":363,"unit":285,"count":682,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903024,{"id":887,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":364,"unit":285,"count":686,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928287,{"id":889,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":365,"unit":285,"count":690,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953585,{"id":891,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":366,"unit":285,"count":694,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979156,{"id":893,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":367,"unit":285,"count":698,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004594,{"id":895,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":368,"unit":285,"count":702,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030032,{"id":897,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":369,"unit":285,"count":706,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055386,{"id":899,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":370,"unit":285,"count":710,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080901,{"id":901,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":371,"unit":285,"count":714,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106339,{"code2_name":903,"code2":904,"items":905},"輸入品☆","cat02_30",[906],{"code1_name":374,"code1":378,"data":907},{"201901":908,"201902":910,"201903":913,"201904":915,"201905":918,"201906":920,"201907":922,"201908":924,"201909":927,"201910":930,"201911":932,"201912":935,"202001":937,"202002":939,"202003":942,"202004":944,"202005":946,"202006":948,"202007":951,"202008":953,"202009":956,"202010":958,"202011":960,"202012":963,"202101":966,"202102":968,"202103":970,"202104":972,"202105":974,"202106":976,"202107":979,"202108":982,"202109":984,"202110":986,"202111":988,"202112":990,"202201":992,"202202":994,"202203":996,"202204":998,"202205":1000,"202206":1002,"202207":1004,"202208":1006,"202209":1008,"202210":1010,"202211":1012,"202212":1014,"202301":1016,"202302":1018,"202303":1020,"202304":1022,"202305":1024,"202306":1026,"202307":1028,"202308":1030,"202309":1032,"202310":1034,"202311":1036,"202312":1038,"202401":1040,"202402":1042,"202403":1044,"202404":1046,"202405":1048,"202406":1050,"202407":1052,"202408":1054,"202409":1056,"202410":1058,"202411":1060,"202412":1062,"202501":1064,"202502":1066,"202503":1068,"202504":1070,"202505":1072,"202506":1074,"202507":1076,"202508":1078,"202509":1080,"202510":1082,"202511":1084,"202512":1086},{"id":909,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":288,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":383},442607,{"id":911,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":289,"unit":285,"count":912,"stats_id":276,"stats_item_id":283,"inserted_at":387},455776,80,{"id":914,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":290,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":391},468040,{"id":916,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":291,"unit":285,"count":917,"stats_id":276,"stats_item_id":283,"inserted_at":395},480332,1270,{"id":919,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":292,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":399},492596,{"id":921,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":293,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":403},504874,{"id":923,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":294,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":407},517222,{"id":925,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":295,"unit":285,"count":926,"stats_id":276,"stats_item_id":283,"inserted_at":411},529626,1,{"id":928,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":296,"unit":285,"count":929,"stats_id":276,"stats_item_id":283,"inserted_at":415},541988,1100,{"id":931,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":297,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":419},554378,{"id":933,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":298,"unit":285,"count":934,"stats_id":276,"stats_item_id":283,"inserted_at":423},579088,580,{"id":936,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":299,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":427},591324,{"id":938,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":300,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":431},786400,{"id":940,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":301,"unit":285,"count":941,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118263,500,{"id":943,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":302,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":439},798629,{"id":945,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":303,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":443},809927,{"id":947,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":304,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":447},822303,{"id":949,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":305,"unit":285,"count":950,"stats_id":276,"stats_item_id":283,"inserted_at":451},834602,920,{"id":952,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":306,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":455},846992,{"id":954,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":307,"unit":285,"count":955,"stats_id":276,"stats_item_id":283,"inserted_at":459},859431,240,{"id":957,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":308,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":463},871849,{"id":959,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":309,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":467},884365,{"id":961,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":310,"unit":285,"count":962,"stats_id":276,"stats_item_id":283,"inserted_at":471},896734,490,{"id":964,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":311,"unit":285,"count":965,"stats_id":276,"stats_item_id":283,"inserted_at":475},909117,755,{"id":967,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":312,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400706,{"id":969,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":313,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412942,{"id":971,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":314,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425437,{"id":973,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":315,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438030,{"id":975,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":316,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450476,{"id":977,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":317,"unit":285,"count":978,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462761,600,{"id":980,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":318,"unit":285,"count":981,"stats_id":276,"stats_item_id":283,"inserted_at":503},1474997,212,{"id":983,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":319,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487359,{"id":985,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":320,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499749,{"id":987,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":321,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512244,{"id":989,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":322,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524571,{"id":991,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":323,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536947,{"id":993,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":324,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848489,{"id":995,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":325,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836162,{"id":997,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":326,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823688,{"id":999,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":327,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811165,{"id":1001,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":328,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798607,{"id":1003,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":329,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786077,{"id":1005,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":330,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773519,{"id":1007,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":331,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761024,{"id":1009,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":332,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748375,{"id":1011,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":333,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723140,{"id":1013,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":334,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710554,{"id":1015,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":335,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697905,{"id":1017,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":336,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152107,{"id":1019,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":337,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139409,{"id":1021,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":338,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126683,{"id":1023,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":339,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113950,{"id":1025,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":340,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101294,{"id":1027,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":341,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088505,{"id":1029,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":342,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075702,{"id":1031,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":343,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062955,{"id":1033,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":344,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050145,{"id":1035,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":345,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037356,{"id":1037,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":346,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024560,{"id":1039,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":347,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011694,{"id":1041,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":348,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381924,{"id":1043,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":349,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394692,{"id":1045,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":350,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407474,{"id":1047,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":351,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420249,{"id":1049,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":352,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433045,{"id":1051,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":353,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535161,{"id":1053,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":354,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611552,{"id":1055,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":355,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698919,{"id":1057,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":356,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724322,{"id":1059,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":357,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749732,{"id":1061,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":358,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775268,{"id":1063,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":359,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801007,{"id":1065,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":360,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826564,{"id":1067,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":361,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852009,{"id":1069,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":362,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877559,{"id":1071,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":363,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903025,{"id":1073,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":364,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928288,{"id":1075,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":365,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953586,{"id":1077,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":366,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979157,{"id":1079,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":367,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004595,{"id":1081,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":368,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030033,{"id":1083,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":369,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055387,{"id":1085,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":370,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080902,{"id":1087,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":371,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106340,{"code2_name":1089,"code2":1090,"items":1091},"出荷","cat02_55",[1092,1343,1516],{"code1_name":1093,"code1":1094,"data":1095},"国内","cat01_30",{"201901":1096,"201902":1099,"201903":1102,"201904":1105,"201905":1108,"201906":1110,"201907":1113,"201908":1116,"201909":1119,"201910":1122,"201911":1125,"201912":1128,"202001":1131,"202002":1134,"202003":1137,"202004":1139,"202005":1142,"202006":1145,"202007":1148,"202008":1151,"202009":1154,"202010":1157,"202011":1160,"202012":1163,"202101":1166,"202102":1169,"202103":1172,"202104":1175,"202105":1178,"202106":1181,"202107":1184,"202108":1187,"202109":1190,"202110":1193,"202111":1196,"202112":1199,"202201":1202,"202202":1205,"202203":1208,"202204":1211,"202205":1214,"202206":1217,"202207":1220,"202208":1223,"202209":1226,"202210":1229,"202211":1232,"202212":1235,"202301":1238,"202302":1241,"202303":1244,"202304":1247,"202305":1250,"202306":1253,"202307":1255,"202308":1258,"202309":1261,"202310":1264,"202311":1267,"202312":1269,"202401":1272,"202402":1275,"202403":1278,"202404":1281,"202405":1284,"202406":1287,"202407":1290,"202408":1293,"202409":1296,"202410":1299,"202411":1302,"202412":1305,"202501":1308,"202502":1311,"202503":1314,"202504":1317,"202505":1320,"202506":1323,"202507":1326,"202508":1329,"202509":1332,"202510":1335,"202511":1337,"202512":1340},{"id":1097,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":288,"unit":285,"count":1098,"stats_id":276,"stats_item_id":283,"inserted_at":383},442609,1128,{"id":1100,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":289,"unit":285,"count":1101,"stats_id":276,"stats_item_id":283,"inserted_at":387},455778,1468,{"id":1103,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":290,"unit":285,"count":1104,"stats_id":276,"stats_item_id":283,"inserted_at":391},468042,1104,{"id":1106,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":291,"unit":285,"count":1107,"stats_id":276,"stats_item_id":283,"inserted_at":395},480334,1101,{"id":1109,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":292,"unit":285,"count":792,"stats_id":276,"stats_item_id":283,"inserted_at":399},492598,{"id":1111,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":293,"unit":285,"count":1112,"stats_id":276,"stats_item_id":283,"inserted_at":403},504876,1150,{"id":1114,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":294,"unit":285,"count":1115,"stats_id":276,"stats_item_id":283,"inserted_at":407},517224,2381,{"id":1117,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":295,"unit":285,"count":1118,"stats_id":276,"stats_item_id":283,"inserted_at":411},529628,1071,{"id":1120,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":296,"unit":285,"count":1121,"stats_id":276,"stats_item_id":283,"inserted_at":415},541990,1546,{"id":1123,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":297,"unit":285,"count":1124,"stats_id":276,"stats_item_id":283,"inserted_at":419},554380,1298,{"id":1126,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":298,"unit":285,"count":1127,"stats_id":276,"stats_item_id":283,"inserted_at":423},579090,1354,{"id":1129,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":299,"unit":285,"count":1130,"stats_id":276,"stats_item_id":283,"inserted_at":427},591326,1324,{"id":1132,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":300,"unit":285,"count":1133,"stats_id":276,"stats_item_id":283,"inserted_at":431},786402,1500,{"id":1135,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":301,"unit":285,"count":1136,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118265,1139,{"id":1138,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":302,"unit":285,"count":386,"stats_id":276,"stats_item_id":283,"inserted_at":439},798631,{"id":1140,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":303,"unit":285,"count":1141,"stats_id":276,"stats_item_id":283,"inserted_at":443},809929,1033,{"id":1143,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":304,"unit":285,"count":1144,"stats_id":276,"stats_item_id":283,"inserted_at":447},822305,979,{"id":1146,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":305,"unit":285,"count":1147,"stats_id":276,"stats_item_id":283,"inserted_at":451},834604,1550,{"id":1149,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":306,"unit":285,"count":1150,"stats_id":276,"stats_item_id":283,"inserted_at":455},846994,1850,{"id":1152,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":307,"unit":285,"count":1153,"stats_id":276,"stats_item_id":283,"inserted_at":459},859433,1163,{"id":1155,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":308,"unit":285,"count":1156,"stats_id":276,"stats_item_id":283,"inserted_at":463},871851,1361,{"id":1158,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":309,"unit":285,"count":1159,"stats_id":276,"stats_item_id":283,"inserted_at":467},884367,1946,{"id":1161,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":310,"unit":285,"count":1162,"stats_id":276,"stats_item_id":283,"inserted_at":471},896736,1929,{"id":1164,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":311,"unit":285,"count":1165,"stats_id":276,"stats_item_id":283,"inserted_at":475},909119,1644,{"id":1167,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":312,"unit":285,"count":1168,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400708,1746,{"id":1170,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":313,"unit":285,"count":1171,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412944,1636,{"id":1173,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":314,"unit":285,"count":1174,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425439,1022,{"id":1176,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":315,"unit":285,"count":1177,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438032,1645,{"id":1179,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":316,"unit":285,"count":1180,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450478,3710,{"id":1182,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":317,"unit":285,"count":1183,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462763,2559,{"id":1185,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":318,"unit":285,"count":1186,"stats_id":276,"stats_item_id":283,"inserted_at":503},1474999,3148,{"id":1188,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":319,"unit":285,"count":1189,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487361,3304,{"id":1191,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":320,"unit":285,"count":1192,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499751,3471,{"id":1194,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":321,"unit":285,"count":1195,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512246,1940,{"id":1197,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":322,"unit":285,"count":1198,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524573,2006,{"id":1200,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":323,"unit":285,"count":1201,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536949,1881,{"id":1203,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":324,"unit":285,"count":1204,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848491,2380,{"id":1206,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":325,"unit":285,"count":1207,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836164,3185,{"id":1209,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":326,"unit":285,"count":1210,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823690,3372,{"id":1212,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":327,"unit":285,"count":1213,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811167,1866,{"id":1215,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":328,"unit":285,"count":1216,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798609,1890,{"id":1218,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":329,"unit":285,"count":1219,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786079,3048,{"id":1221,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":330,"unit":285,"count":1222,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773521,1888,{"id":1224,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":331,"unit":285,"count":1225,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761026,3575,{"id":1227,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":332,"unit":285,"count":1228,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748377,1605,{"id":1230,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":333,"unit":285,"count":1231,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723142,1750,{"id":1233,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":334,"unit":285,"count":1234,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710556,1887,{"id":1236,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":335,"unit":285,"count":1237,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697907,1376,{"id":1239,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":336,"unit":285,"count":1240,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152109,1927,{"id":1242,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":337,"unit":285,"count":1243,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139411,3134,{"id":1245,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":338,"unit":285,"count":1246,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126685,2630,{"id":1248,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":339,"unit":285,"count":1249,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113952,1691,{"id":1251,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":340,"unit":285,"count":1252,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101296,1748,{"id":1254,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":341,"unit":285,"count":1213,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088507,{"id":1256,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":342,"unit":285,"count":1257,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075704,1889,{"id":1259,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":343,"unit":285,"count":1260,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062957,3345,{"id":1262,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":344,"unit":285,"count":1263,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050147,2317,{"id":1265,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":345,"unit":285,"count":1266,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037358,2014,{"id":1268,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":346,"unit":285,"count":1231,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024562,{"id":1270,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":347,"unit":285,"count":1271,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011696,1668,{"id":1273,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":348,"unit":285,"count":1274,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381926,2024,{"id":1276,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":349,"unit":285,"count":1277,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394694,2052,{"id":1279,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":350,"unit":285,"count":1280,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407476,4214,{"id":1282,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":351,"unit":285,"count":1283,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420251,4244,{"id":1285,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":352,"unit":285,"count":1286,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433047,1911,{"id":1288,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":353,"unit":285,"count":1289,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535163,1981,{"id":1291,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":354,"unit":285,"count":1292,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611554,2470,{"id":1294,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":355,"unit":285,"count":1295,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698921,3389,{"id":1297,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":356,"unit":285,"count":1298,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724324,3307,{"id":1300,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":357,"unit":285,"count":1301,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749734,2453,{"id":1303,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":358,"unit":285,"count":1304,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775270,2062,{"id":1306,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":359,"unit":285,"count":1307,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801009,1899,{"id":1309,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":360,"unit":285,"count":1310,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826566,2144,{"id":1312,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":361,"unit":285,"count":1313,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852011,3936,{"id":1315,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":362,"unit":285,"count":1316,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877561,3464,{"id":1318,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":363,"unit":285,"count":1319,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903027,2203,{"id":1321,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":364,"unit":285,"count":1322,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928290,2306,{"id":1324,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":365,"unit":285,"count":1325,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953588,2490,{"id":1327,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":366,"unit":285,"count":1328,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979159,2706,{"id":1330,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":367,"unit":285,"count":1331,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004597,4018,{"id":1333,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":368,"unit":285,"count":1334,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030035,3618,{"id":1336,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":369,"unit":285,"count":1266,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055389,{"id":1338,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":370,"unit":285,"count":1339,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080904,1910,{"id":1341,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":371,"unit":285,"count":1342,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106342,1871,{"code1_name":1344,"code1":1345,"data":1346},"輸出","cat01_70",{"201901":1347,"201902":1349,"201903":1351,"201904":1353,"201905":1355,"201906":1357,"201907":1359,"201908":1361,"201909":1363,"201910":1365,"201911":1367,"201912":1369,"202001":1371,"202002":1373,"202003":1375,"202004":1378,"202005":1380,"202006":1382,"202007":1384,"202008":1386,"202009":1388,"202010":1390,"202011":1392,"202012":1394,"202101":1396,"202102":1398,"202103":1400,"202104":1402,"202105":1404,"202106":1406,"202107":1408,"202108":1410,"202109":1412,"202110":1414,"202111":1416,"202112":1418,"202201":1420,"202202":1422,"202203":1424,"202204":1426,"202205":1428,"202206":1430,"202207":1432,"202208":1434,"202209":1436,"202210":1438,"202211":1440,"202212":1442,"202301":1444,"202302":1446,"202303":1448,"202304":1450,"202305":1452,"202306":1454,"202307":1456,"202308":1458,"202309":1460,"202310":1462,"202311":1464,"202312":1466,"202401":1468,"202402":1470,"202403":1472,"202404":1474,"202405":1476,"202406":1478,"202407":1480,"202408":1482,"202409":1484,"202410":1486,"202411":1488,"202412":1490,"202501":1492,"202502":1494,"202503":1496,"202504":1498,"202505":1500,"202506":1502,"202507":1504,"202508":1506,"202509":1508,"202510":1510,"202511":1512,"202512":1514},{"id":1348,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":288,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":383},442610,{"id":1350,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":289,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":387},455779,{"id":1352,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":290,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":391},468043,{"id":1354,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":291,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":395},480335,{"id":1356,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":292,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":399},492599,{"id":1358,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":293,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":403},504877,{"id":1360,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":294,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":407},517225,{"id":1362,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":295,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":411},529629,{"id":1364,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":296,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":415},541991,{"id":1366,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":297,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":419},554381,{"id":1368,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":298,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":423},579091,{"id":1370,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":299,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":427},591327,{"id":1372,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":300,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":431},786403,{"id":1374,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":301,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118266,{"id":1376,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":302,"unit":285,"count":1377,"stats_id":276,"stats_item_id":283,"inserted_at":439},798632,150,{"id":1379,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":303,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":443},809930,{"id":1381,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":304,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":447},822306,{"id":1383,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":305,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":451},834605,{"id":1385,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":306,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":455},846995,{"id":1387,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":307,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":459},859434,{"id":1389,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":308,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":463},871852,{"id":1391,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":309,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":467},884368,{"id":1393,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":310,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":471},896737,{"id":1395,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":311,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":475},909120,{"id":1397,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":312,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400709,{"id":1399,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":313,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412945,{"id":1401,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":314,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425440,{"id":1403,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":315,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438033,{"id":1405,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":316,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450479,{"id":1407,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":317,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462764,{"id":1409,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":318,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":503},1475000,{"id":1411,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":319,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487362,{"id":1413,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":320,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499752,{"id":1415,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":321,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512247,{"id":1417,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":322,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524574,{"id":1419,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":323,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536950,{"id":1421,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":324,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848492,{"id":1423,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":325,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836165,{"id":1425,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":326,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823691,{"id":1427,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":327,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811168,{"id":1429,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":328,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798610,{"id":1431,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":329,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786080,{"id":1433,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":330,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773522,{"id":1435,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":331,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761027,{"id":1437,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":332,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748378,{"id":1439,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":333,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723143,{"id":1441,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":334,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710557,{"id":1443,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":335,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697908,{"id":1445,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":336,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152110,{"id":1447,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":337,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139412,{"id":1449,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":338,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126686,{"id":1451,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":339,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113953,{"id":1453,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":340,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101297,{"id":1455,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":341,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088508,{"id":1457,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":342,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075705,{"id":1459,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":343,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062958,{"id":1461,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":344,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050148,{"id":1463,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":345,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037359,{"id":1465,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":346,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024563,{"id":1467,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":347,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011697,{"id":1469,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":348,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381927,{"id":1471,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":349,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394695,{"id":1473,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":350,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407477,{"id":1475,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":351,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420252,{"id":1477,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":352,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433048,{"id":1479,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":353,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535164,{"id":1481,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":354,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611555,{"id":1483,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":355,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698922,{"id":1485,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":356,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724325,{"id":1487,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":357,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749735,{"id":1489,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":358,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775271,{"id":1491,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":359,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801010,{"id":1493,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":360,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826567,{"id":1495,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":361,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852012,{"id":1497,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":362,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877562,{"id":1499,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":363,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903028,{"id":1501,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":364,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928291,{"id":1503,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":365,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953589,{"id":1505,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":366,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979160,{"id":1507,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":367,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004598,{"id":1509,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":368,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030036,{"id":1511,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":369,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055390,{"id":1513,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":370,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080905,{"id":1515,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":371,"unit":285,"count":185,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106343,{"code1_name":374,"code1":378,"data":1517},{"201901":1518,"201902":1520,"201903":1522,"201904":1524,"201905":1526,"201906":1528,"201907":1530,"201908":1532,"201909":1534,"201910":1536,"201911":1538,"201912":1540,"202001":1542,"202002":1544,"202003":1546,"202004":1549,"202005":1551,"202006":1553,"202007":1555,"202008":1557,"202009":1559,"202010":1561,"202011":1563,"202012":1565,"202101":1567,"202102":1569,"202103":1571,"202104":1573,"202105":1575,"202106":1577,"202107":1579,"202108":1581,"202109":1583,"202110":1585,"202111":1587,"202112":1589,"202201":1591,"202202":1593,"202203":1595,"202204":1597,"202205":1599,"202206":1601,"202207":1603,"202208":1605,"202209":1607,"202210":1609,"202211":1611,"202212":1613,"202301":1615,"202302":1617,"202303":1619,"202304":1621,"202305":1623,"202306":1625,"202307":1627,"202308":1629,"202309":1631,"202310":1633,"202311":1635,"202312":1637,"202401":1639,"202402":1641,"202403":1643,"202404":1645,"202405":1647,"202406":1649,"202407":1651,"202408":1653,"202409":1655,"202410":1657,"202411":1659,"202412":1661,"202501":1663,"202502":1665,"202503":1667,"202504":1669,"202505":1671,"202506":1673,"202507":1675,"202508":1677,"202509":1679,"202510":1681,"202511":1683,"202512":1685},{"id":1519,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":288,"unit":285,"count":1098,"stats_id":276,"stats_item_id":283,"inserted_at":383},442608,{"id":1521,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":289,"unit":285,"count":1101,"stats_id":276,"stats_item_id":283,"inserted_at":387},455777,{"id":1523,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":290,"unit":285,"count":1104,"stats_id":276,"stats_item_id":283,"inserted_at":391},468041,{"id":1525,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":291,"unit":285,"count":1107,"stats_id":276,"stats_item_id":283,"inserted_at":395},480333,{"id":1527,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":292,"unit":285,"count":792,"stats_id":276,"stats_item_id":283,"inserted_at":399},492597,{"id":1529,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":293,"unit":285,"count":1112,"stats_id":276,"stats_item_id":283,"inserted_at":403},504875,{"id":1531,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":294,"unit":285,"count":1115,"stats_id":276,"stats_item_id":283,"inserted_at":407},517223,{"id":1533,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":295,"unit":285,"count":1118,"stats_id":276,"stats_item_id":283,"inserted_at":411},529627,{"id":1535,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":296,"unit":285,"count":1121,"stats_id":276,"stats_item_id":283,"inserted_at":415},541989,{"id":1537,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":297,"unit":285,"count":1124,"stats_id":276,"stats_item_id":283,"inserted_at":419},554379,{"id":1539,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":298,"unit":285,"count":1127,"stats_id":276,"stats_item_id":283,"inserted_at":423},579089,{"id":1541,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":299,"unit":285,"count":1130,"stats_id":276,"stats_item_id":283,"inserted_at":427},591325,{"id":1543,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":300,"unit":285,"count":1133,"stats_id":276,"stats_item_id":283,"inserted_at":431},786401,{"id":1545,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":301,"unit":285,"count":1136,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118264,{"id":1547,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":302,"unit":285,"count":1548,"stats_id":276,"stats_item_id":283,"inserted_at":439},798630,959,{"id":1550,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":303,"unit":285,"count":1141,"stats_id":276,"stats_item_id":283,"inserted_at":443},809928,{"id":1552,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":304,"unit":285,"count":1144,"stats_id":276,"stats_item_id":283,"inserted_at":447},822304,{"id":1554,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":305,"unit":285,"count":1147,"stats_id":276,"stats_item_id":283,"inserted_at":451},834603,{"id":1556,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":306,"unit":285,"count":1150,"stats_id":276,"stats_item_id":283,"inserted_at":455},846993,{"id":1558,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":307,"unit":285,"count":1153,"stats_id":276,"stats_item_id":283,"inserted_at":459},859432,{"id":1560,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":308,"unit":285,"count":1156,"stats_id":276,"stats_item_id":283,"inserted_at":463},871850,{"id":1562,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":309,"unit":285,"count":1159,"stats_id":276,"stats_item_id":283,"inserted_at":467},884366,{"id":1564,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":310,"unit":285,"count":1162,"stats_id":276,"stats_item_id":283,"inserted_at":471},896735,{"id":1566,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":311,"unit":285,"count":1165,"stats_id":276,"stats_item_id":283,"inserted_at":475},909118,{"id":1568,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":312,"unit":285,"count":1168,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400707,{"id":1570,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":313,"unit":285,"count":1171,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412943,{"id":1572,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":314,"unit":285,"count":1174,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425438,{"id":1574,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":315,"unit":285,"count":1177,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438031,{"id":1576,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":316,"unit":285,"count":1180,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450477,{"id":1578,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":317,"unit":285,"count":1183,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462762,{"id":1580,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":318,"unit":285,"count":1186,"stats_id":276,"stats_item_id":283,"inserted_at":503},1474998,{"id":1582,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":319,"unit":285,"count":1189,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487360,{"id":1584,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":320,"unit":285,"count":1192,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499750,{"id":1586,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":321,"unit":285,"count":1195,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512245,{"id":1588,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":322,"unit":285,"count":1198,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524572,{"id":1590,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":323,"unit":285,"count":1201,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536948,{"id":1592,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":324,"unit":285,"count":1204,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848490,{"id":1594,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":325,"unit":285,"count":1207,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836163,{"id":1596,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":326,"unit":285,"count":1210,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823689,{"id":1598,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":327,"unit":285,"count":1213,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811166,{"id":1600,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":328,"unit":285,"count":1216,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798608,{"id":1602,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":329,"unit":285,"count":1219,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786078,{"id":1604,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":330,"unit":285,"count":1222,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773520,{"id":1606,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":331,"unit":285,"count":1225,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761025,{"id":1608,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":332,"unit":285,"count":1228,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748376,{"id":1610,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":333,"unit":285,"count":1231,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723141,{"id":1612,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":334,"unit":285,"count":1234,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710555,{"id":1614,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":335,"unit":285,"count":1237,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697906,{"id":1616,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":336,"unit":285,"count":1240,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152108,{"id":1618,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":337,"unit":285,"count":1243,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139410,{"id":1620,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":338,"unit":285,"count":1246,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126684,{"id":1622,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":339,"unit":285,"count":1249,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113951,{"id":1624,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":340,"unit":285,"count":1252,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101295,{"id":1626,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":341,"unit":285,"count":1213,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088506,{"id":1628,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":342,"unit":285,"count":1257,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075703,{"id":1630,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":343,"unit":285,"count":1260,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062956,{"id":1632,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":344,"unit":285,"count":1263,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050146,{"id":1634,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":345,"unit":285,"count":1266,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037357,{"id":1636,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":346,"unit":285,"count":1231,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024561,{"id":1638,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":347,"unit":285,"count":1271,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011695,{"id":1640,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":348,"unit":285,"count":1274,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381925,{"id":1642,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":349,"unit":285,"count":1277,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394693,{"id":1644,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":350,"unit":285,"count":1280,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407475,{"id":1646,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":351,"unit":285,"count":1283,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420250,{"id":1648,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":352,"unit":285,"count":1286,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433046,{"id":1650,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":353,"unit":285,"count":1289,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535162,{"id":1652,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":354,"unit":285,"count":1292,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611553,{"id":1654,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":355,"unit":285,"count":1295,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698920,{"id":1656,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":356,"unit":285,"count":1298,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724323,{"id":1658,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":357,"unit":285,"count":1301,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749733,{"id":1660,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":358,"unit":285,"count":1304,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775269,{"id":1662,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":359,"unit":285,"count":1307,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801008,{"id":1664,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":360,"unit":285,"count":1310,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826565,{"id":1666,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":361,"unit":285,"count":1313,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852010,{"id":1668,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":362,"unit":285,"count":1316,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877560,{"id":1670,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":363,"unit":285,"count":1319,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903026,{"id":1672,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":364,"unit":285,"count":1322,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928289,{"id":1674,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":365,"unit":285,"count":1325,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953587,{"id":1676,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":366,"unit":285,"count":1328,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979158,{"id":1678,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":367,"unit":285,"count":1331,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004596,{"id":1680,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":368,"unit":285,"count":1334,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030034,{"id":1682,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":369,"unit":285,"count":1266,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055388,{"id":1684,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":370,"unit":285,"count":1339,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080903,{"id":1686,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":371,"unit":285,"count":1342,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106341,{"code2_name":1688,"code2":1689,"items":1690},"月末在庫","cat02_80",[1691],{"code1_name":374,"code1":378,"data":1692},{"201901":1693,"201902":1696,"201903":1699,"201904":1702,"201905":1705,"201906":1708,"201907":1711,"201908":1714,"201909":1717,"201910":1720,"201911":1723,"201912":1726,"202001":1729,"202002":1732,"202003":1735,"202004":1738,"202005":1741,"202006":1744,"202007":1747,"202008":1750,"202009":1753,"202010":1756,"202011":1759,"202012":1762,"202101":1765,"202102":1768,"202103":1771,"202104":1774,"202105":1777,"202106":1780,"202107":1783,"202108":1786,"202109":1789,"202110":1792,"202111":1795,"202112":1798,"202201":1801,"202202":1804,"202203":1807,"202204":1810,"202205":1813,"202206":1816,"202207":1819,"202208":1822,"202209":1825,"202210":1828,"202211":1831,"202212":1834,"202301":1837,"202302":1840,"202303":1843,"202304":1846,"202305":1849,"202306":1852,"202307":1855,"202308":1858,"202309":1861,"202310":1864,"202311":1867,"202312":1870,"202401":1873,"202402":1876,"202403":1879,"202404":1882,"202405":1885,"202406":1888,"202407":1891,"202408":1894,"202409":1897,"202410":1900,"202411":1903,"202412":1906,"202501":1909,"202502":1912,"202503":1915,"202504":1918,"202505":1921,"202506":1924,"202507":1927,"202508":1929,"202509":1932,"202510":1934,"202511":1937,"202512":1940},{"id":1694,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":288,"unit":285,"count":1695,"stats_id":276,"stats_item_id":283,"inserted_at":383},442611,3362,{"id":1697,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":289,"unit":285,"count":1698,"stats_id":276,"stats_item_id":283,"inserted_at":387},455780,2499,{"id":1700,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":290,"unit":285,"count":1701,"stats_id":276,"stats_item_id":283,"inserted_at":391},468044,2980,{"id":1703,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":291,"unit":285,"count":1704,"stats_id":276,"stats_item_id":283,"inserted_at":395},480336,4217,{"id":1706,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":292,"unit":285,"count":1707,"stats_id":276,"stats_item_id":283,"inserted_at":399},492600,5247,{"id":1709,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":293,"unit":285,"count":1710,"stats_id":276,"stats_item_id":283,"inserted_at":403},504878,6768,{"id":1712,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":294,"unit":285,"count":1713,"stats_id":276,"stats_item_id":283,"inserted_at":407},517226,5405,{"id":1715,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":295,"unit":285,"count":1716,"stats_id":276,"stats_item_id":283,"inserted_at":411},529630,4980,{"id":1718,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":296,"unit":285,"count":1719,"stats_id":276,"stats_item_id":283,"inserted_at":415},541992,3647,{"id":1721,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":297,"unit":285,"count":1722,"stats_id":276,"stats_item_id":283,"inserted_at":419},554382,4557,{"id":1724,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":298,"unit":285,"count":1725,"stats_id":276,"stats_item_id":283,"inserted_at":423},579092,5249,{"id":1727,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":299,"unit":285,"count":1728,"stats_id":276,"stats_item_id":283,"inserted_at":427},591328,4688,{"id":1730,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":300,"unit":285,"count":1731,"stats_id":276,"stats_item_id":283,"inserted_at":431},786404,4216,{"id":1733,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":301,"unit":285,"count":1734,"stats_id":276,"stats_item_id":283,"inserted_at":435},1118267,2995,{"id":1736,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":302,"unit":285,"count":1737,"stats_id":276,"stats_item_id":283,"inserted_at":439},798633,5200,{"id":1739,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":303,"unit":285,"count":1740,"stats_id":276,"stats_item_id":283,"inserted_at":443},809931,6435,{"id":1742,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":304,"unit":285,"count":1743,"stats_id":276,"stats_item_id":283,"inserted_at":447},822307,5717,{"id":1745,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":305,"unit":285,"count":1746,"stats_id":276,"stats_item_id":283,"inserted_at":451},834606,6092,{"id":1748,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":306,"unit":285,"count":1749,"stats_id":276,"stats_item_id":283,"inserted_at":455},846996,4353,{"id":1751,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":307,"unit":285,"count":1752,"stats_id":276,"stats_item_id":283,"inserted_at":459},859435,4695,{"id":1754,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":308,"unit":285,"count":1755,"stats_id":276,"stats_item_id":283,"inserted_at":463},871853,4130,{"id":1757,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":309,"unit":285,"count":1758,"stats_id":276,"stats_item_id":283,"inserted_at":467},884369,4576,{"id":1760,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":310,"unit":285,"count":1761,"stats_id":276,"stats_item_id":283,"inserted_at":471},896738,5021,{"id":1763,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":311,"unit":285,"count":1764,"stats_id":276,"stats_item_id":283,"inserted_at":475},909121,4644,{"id":1766,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":312,"unit":285,"count":1767,"stats_id":276,"stats_item_id":283,"inserted_at":479},1400710,4610,{"id":1769,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":313,"unit":285,"count":1770,"stats_id":276,"stats_item_id":283,"inserted_at":483},1412946,2892,{"id":1772,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":314,"unit":285,"count":1773,"stats_id":276,"stats_item_id":283,"inserted_at":487},1425441,4926,{"id":1775,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":315,"unit":285,"count":1776,"stats_id":276,"stats_item_id":283,"inserted_at":491},1438034,5789,{"id":1778,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":316,"unit":285,"count":1779,"stats_id":276,"stats_item_id":283,"inserted_at":495},1450480,9558,{"id":1781,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":317,"unit":285,"count":1782,"stats_id":276,"stats_item_id":283,"inserted_at":499},1462765,8442,{"id":1784,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":318,"unit":285,"count":1785,"stats_id":276,"stats_item_id":283,"inserted_at":503},1475001,11363,{"id":1787,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":319,"unit":285,"count":1788,"stats_id":276,"stats_item_id":283,"inserted_at":507},1487363,10178,{"id":1790,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":320,"unit":285,"count":1791,"stats_id":276,"stats_item_id":283,"inserted_at":511},1499753,10362,{"id":1793,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":321,"unit":285,"count":1794,"stats_id":276,"stats_item_id":283,"inserted_at":515},1512248,9408,{"id":1796,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":322,"unit":285,"count":1797,"stats_id":276,"stats_item_id":283,"inserted_at":519},1524575,11747,{"id":1799,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":323,"unit":285,"count":1800,"stats_id":276,"stats_item_id":283,"inserted_at":523},1536951,14188,{"id":1802,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":324,"unit":285,"count":1803,"stats_id":276,"stats_item_id":283,"inserted_at":527},1848493,18081,{"id":1805,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":325,"unit":285,"count":1806,"stats_id":276,"stats_item_id":283,"inserted_at":531},1836166,17794,{"id":1808,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":326,"unit":285,"count":1809,"stats_id":276,"stats_item_id":283,"inserted_at":535},1823692,15862,{"id":1811,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":327,"unit":285,"count":1812,"stats_id":276,"stats_item_id":283,"inserted_at":539},1811169,14985,{"id":1814,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":328,"unit":285,"count":1815,"stats_id":276,"stats_item_id":283,"inserted_at":543},1798611,14748,{"id":1817,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":329,"unit":285,"count":1818,"stats_id":276,"stats_item_id":283,"inserted_at":547},1786081,13794,{"id":1820,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":330,"unit":285,"count":1821,"stats_id":276,"stats_item_id":283,"inserted_at":551},1773523,14550,{"id":1823,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":331,"unit":285,"count":1824,"stats_id":276,"stats_item_id":283,"inserted_at":555},1761028,15136,{"id":1826,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":332,"unit":285,"count":1827,"stats_id":276,"stats_item_id":283,"inserted_at":559},1748379,15602,{"id":1829,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":333,"unit":285,"count":1830,"stats_id":276,"stats_item_id":283,"inserted_at":563},1723144,16562,{"id":1832,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":334,"unit":285,"count":1833,"stats_id":276,"stats_item_id":283,"inserted_at":567},1710558,17993,{"id":1835,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":335,"unit":285,"count":1836,"stats_id":276,"stats_item_id":283,"inserted_at":571},1697909,19255,{"id":1838,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":336,"unit":285,"count":1839,"stats_id":276,"stats_item_id":283,"inserted_at":575},2152111,21149,{"id":1841,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":337,"unit":285,"count":1842,"stats_id":276,"stats_item_id":283,"inserted_at":579},2139413,20350,{"id":1844,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":338,"unit":285,"count":1845,"stats_id":276,"stats_item_id":283,"inserted_at":583},2126687,17988,{"id":1847,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":339,"unit":285,"count":1848,"stats_id":276,"stats_item_id":283,"inserted_at":587},2113954,17526,{"id":1850,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":340,"unit":285,"count":1851,"stats_id":276,"stats_item_id":283,"inserted_at":591},2101298,17465,{"id":1853,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":341,"unit":285,"count":1854,"stats_id":276,"stats_item_id":283,"inserted_at":595},2088509,18188,{"id":1856,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":342,"unit":285,"count":1857,"stats_id":276,"stats_item_id":283,"inserted_at":599},2075706,16261,{"id":1859,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":343,"unit":285,"count":1860,"stats_id":276,"stats_item_id":283,"inserted_at":603},2062959,14732,{"id":1862,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":344,"unit":285,"count":1863,"stats_id":276,"stats_item_id":283,"inserted_at":607},2050149,14951,{"id":1865,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":345,"unit":285,"count":1866,"stats_id":276,"stats_item_id":283,"inserted_at":611},2037360,12656,{"id":1868,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":346,"unit":285,"count":1869,"stats_id":276,"stats_item_id":283,"inserted_at":615},2024564,12141,{"id":1871,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":347,"unit":285,"count":1872,"stats_id":276,"stats_item_id":283,"inserted_at":619},2011698,11991,{"id":1874,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":348,"unit":285,"count":1875,"stats_id":276,"stats_item_id":283,"inserted_at":623},2381928,11625,{"id":1877,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":349,"unit":285,"count":1878,"stats_id":276,"stats_item_id":283,"inserted_at":627},2394696,12361,{"id":1880,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":350,"unit":285,"count":1881,"stats_id":276,"stats_item_id":283,"inserted_at":631},2407478,10106,{"id":1883,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":351,"unit":285,"count":1884,"stats_id":276,"stats_item_id":283,"inserted_at":635},2420253,8198,{"id":1886,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":352,"unit":285,"count":1887,"stats_id":276,"stats_item_id":283,"inserted_at":639},2433049,10311,{"id":1889,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":353,"unit":285,"count":1890,"stats_id":276,"stats_item_id":283,"inserted_at":643},2535165,9353,{"id":1892,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":354,"unit":285,"count":1893,"stats_id":276,"stats_item_id":283,"inserted_at":647},2611556,11352,{"id":1895,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":355,"unit":285,"count":1896,"stats_id":276,"stats_item_id":283,"inserted_at":651},2698923,11118,{"id":1898,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":356,"unit":285,"count":1899,"stats_id":276,"stats_item_id":283,"inserted_at":655},2724326,8878,{"id":1901,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":357,"unit":285,"count":1902,"stats_id":276,"stats_item_id":283,"inserted_at":659},2749736,10169,{"id":1904,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":358,"unit":285,"count":1905,"stats_id":276,"stats_item_id":283,"inserted_at":663},2775272,10997,{"id":1907,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":359,"unit":285,"count":1908,"stats_id":276,"stats_item_id":283,"inserted_at":667},2801011,11237,{"id":1910,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":360,"unit":285,"count":1911,"stats_id":276,"stats_item_id":283,"inserted_at":671},2826568,12469,{"id":1913,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":361,"unit":285,"count":1914,"stats_id":276,"stats_item_id":283,"inserted_at":675},2852013,11996,{"id":1916,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":362,"unit":285,"count":1917,"stats_id":276,"stats_item_id":283,"inserted_at":679},2877563,11796,{"id":1919,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":363,"unit":285,"count":1920,"stats_id":276,"stats_item_id":283,"inserted_at":683},2903029,12110,{"id":1922,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":364,"unit":285,"count":1923,"stats_id":276,"stats_item_id":283,"inserted_at":687},2928292,12398,{"id":1925,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":365,"unit":285,"count":1926,"stats_id":276,"stats_item_id":283,"inserted_at":691},2953590,10657,{"id":1928,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":366,"unit":285,"count":1902,"stats_id":276,"stats_item_id":283,"inserted_at":695},2979161,{"id":1930,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":367,"unit":285,"count":1931,"stats_id":276,"stats_item_id":283,"inserted_at":699},3004599,11718,{"id":1933,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":368,"unit":285,"count":1902,"stats_id":276,"stats_item_id":283,"inserted_at":703},3030037,{"id":1935,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":369,"unit":285,"count":1936,"stats_id":276,"stats_item_id":283,"inserted_at":707},3055391,9354,{"id":1938,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":370,"unit":285,"count":1939,"stats_id":276,"stats_item_id":283,"inserted_at":711},3080906,9242,{"id":1941,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":371,"unit":285,"count":1942,"stats_id":276,"stats_item_id":283,"inserted_at":715},3106344,10486,{"stat":1944,"timeList":1952,"groupedData":1953},{"id":204,"table_id":1945,"table_name":1946,"stats_name":279,"updated_date":1947,"stats_items":1948},"000031858704","医療機器一般的名称別生産・輸入・出荷・月末在庫金額","2024-08-26",[1949],{"id":1950,"code":189,"name":284,"unit":1951,"level":286,"stats_id":204,"parent_item_id":185,"parent_item_code":186},31718,"千円",[288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371],[1954,2294,2478,2661,3259],{"code2_name":374,"code2":375,"items":1955},[1956],{"code1_name":374,"code1":378,"data":1957},{"201901":1958,"201902":1962,"201903":1966,"201904":1970,"201905":1974,"201906":1978,"201907":1982,"201908":1986,"201909":1990,"201910":1994,"201911":1998,"201912":2002,"202001":2006,"202002":2010,"202003":2014,"202004":2018,"202005":2022,"202006":2026,"202007":2030,"202008":2034,"202009":2038,"202010":2042,"202011":2046,"202012":2050,"202101":2054,"202102":2058,"202103":2062,"202104":2066,"202105":2070,"202106":2074,"202107":2078,"202108":2082,"202109":2086,"202110":2090,"202111":2094,"202112":2098,"202201":2102,"202202":2106,"202203":2110,"202204":2114,"202205":2118,"202206":2122,"202207":2126,"202208":2130,"202209":2134,"202210":2138,"202211":2142,"202212":2146,"202301":2150,"202302":2154,"202303":2158,"202304":2162,"202305":2166,"202306":2170,"202307":2174,"202308":2178,"202309":2182,"202310":2186,"202311":2190,"202312":2194,"202401":2198,"202402":2202,"202403":2206,"202404":2210,"202405":2214,"202406":2218,"202407":2222,"202408":2226,"202409":2230,"202410":2234,"202411":2238,"202412":2242,"202501":2246,"202502":2250,"202503":2254,"202504":2258,"202505":2262,"202506":2266,"202507":2270,"202508":2274,"202509":2278,"202510":2282,"202511":2286,"202512":2290},{"id":1959,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":288,"unit":1951,"count":1960,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639538,1340,"2024-08-29T15:14:50.124782+00:00",{"id":1963,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":289,"unit":1951,"count":1964,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651501,13133,"2024-08-29T15:34:51.751466+00:00",{"id":1967,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":290,"unit":1951,"count":1968,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663695,21179,"2024-08-29T15:34:56.905205+00:00",{"id":1971,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":291,"unit":1951,"count":1972,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675917,48134,"2024-08-29T15:35:00.395206+00:00",{"id":1975,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":292,"unit":1951,"count":1976,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688111,32726,"2024-08-29T15:35:03.825225+00:00",{"id":1979,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":293,"unit":1951,"count":1980,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700319,24467,"2024-08-29T15:35:07.263161+00:00",{"id":1983,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":294,"unit":1951,"count":1984,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712597,11944,"2024-08-29T15:35:11.152808+00:00",{"id":1987,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":295,"unit":1951,"count":1988,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724931,11432,"2024-08-29T15:35:14.557135+00:00",{"id":1991,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":296,"unit":1951,"count":1992,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737223,32108,"2024-08-29T15:35:17.63276+00:00",{"id":1995,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":297,"unit":1951,"count":1996,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749536,9789,"2024-08-29T15:35:21.350009+00:00",{"id":1999,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":298,"unit":1951,"count":2000,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774162,29493,"2024-08-29T15:36:07.477115+00:00",{"id":2003,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":299,"unit":1951,"count":2004,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761814,8709,"2024-08-29T15:35:38.133149+00:00",{"id":2007,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":300,"unit":1951,"count":2008,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253347,11682,"2024-08-29T16:12:36.309177+00:00",{"id":2011,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":301,"unit":1951,"count":2012,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265604,22291,"2024-08-29T16:12:40.144508+00:00",{"id":2015,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":302,"unit":1951,"count":2016,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278050,30122,"2024-08-29T16:12:45.243449+00:00",{"id":2019,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":303,"unit":1951,"count":2020,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289348,24465,"2024-08-29T16:12:51.079896+00:00",{"id":2023,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":304,"unit":1951,"count":2024,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301724,369,"2024-08-29T16:12:55.613323+00:00",{"id":2027,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":305,"unit":1951,"count":2028,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314023,34051,"2024-08-29T16:12:59.312416+00:00",{"id":2031,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":306,"unit":1951,"count":2032,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326413,3076,"2024-08-29T16:13:02.998452+00:00",{"id":2035,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":307,"unit":1951,"count":2036,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338852,28364,"2024-08-29T16:13:06.565563+00:00",{"id":2039,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":308,"unit":1951,"count":2040,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351270,15968,"2024-08-29T16:13:09.466836+00:00",{"id":2043,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":309,"unit":1951,"count":2044,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363786,23036,"2024-08-29T16:13:13.151041+00:00",{"id":2047,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":310,"unit":1951,"count":2048,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376155,43616,"2024-08-29T16:13:16.500693+00:00",{"id":2051,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":311,"unit":1951,"count":2052,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388538,22519,"2024-08-29T16:13:19.246757+00:00",{"id":2055,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":312,"unit":1951,"count":2056,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549300,25362,"2024-08-29T16:39:03.837211+00:00",{"id":2059,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":313,"unit":1951,"count":2060,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561536,6436,"2024-08-29T16:39:10.866016+00:00",{"id":2063,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":314,"unit":1951,"count":2064,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574031,52388,"2024-08-29T16:39:16.083285+00:00",{"id":2067,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":315,"unit":1951,"count":2068,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586624,26583,"2024-08-29T16:39:21.56438+00:00",{"id":2071,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":316,"unit":1951,"count":2072,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599070,49919,"2024-08-29T16:39:26.344239+00:00",{"id":2075,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":317,"unit":1951,"count":2076,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611355,34324,"2024-08-29T16:39:31.430542+00:00",{"id":2079,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":318,"unit":1951,"count":2080,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623591,31633,"2024-08-29T16:39:36.313029+00:00",{"id":2083,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":319,"unit":1951,"count":2084,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635953,38538,"2024-08-29T16:39:42.318816+00:00",{"id":2087,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":320,"unit":1951,"count":2088,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648343,30470,"2024-08-29T16:39:47.068485+00:00",{"id":2091,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":321,"unit":1951,"count":2092,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660838,28140,"2024-08-29T16:39:51.621645+00:00",{"id":2095,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":322,"unit":1951,"count":2096,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673165,42194,"2024-08-29T16:39:54.931896+00:00",{"id":2099,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":323,"unit":1951,"count":2100,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685541,50535,"2024-08-29T16:39:59.87799+00:00",{"id":2103,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":324,"unit":1951,"count":2104,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998791,49180,"2024-08-29T16:55:54.529248+00:00",{"id":2107,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":325,"unit":1951,"count":2108,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986464,56653,"2024-08-29T16:55:51.647865+00:00",{"id":2111,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":326,"unit":1951,"count":2112,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973990,26049,"2024-08-29T16:55:48.601088+00:00",{"id":2115,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":327,"unit":1951,"count":2116,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961467,12056,"2024-08-29T16:55:44.811071+00:00",{"id":2119,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":328,"unit":1951,"count":2120,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948909,26407,"2024-08-29T16:55:41.845174+00:00",{"id":2123,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":329,"unit":1951,"count":2124,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936379,31452,"2024-08-29T16:55:39.008318+00:00",{"id":2127,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":330,"unit":1951,"count":2128,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923821,29697,"2024-08-29T16:55:35.617665+00:00",{"id":2131,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":331,"unit":1951,"count":2132,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911326,55951,"2024-08-29T16:55:31.374785+00:00",{"id":2135,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":332,"unit":1951,"count":2136,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898677,30298,"2024-08-29T16:55:26.043475+00:00",{"id":2139,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":333,"unit":1951,"count":2140,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886063,35244,"2024-08-29T16:55:22.699464+00:00",{"id":2143,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":334,"unit":1951,"count":2144,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873477,51741,"2024-08-29T16:55:17.585124+00:00",{"id":2147,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":335,"unit":1951,"count":2148,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860828,32834,"2024-08-29T16:55:14.377076+00:00",{"id":2151,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":336,"unit":1951,"count":2152,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164817,50560,"2024-08-29T18:32:34.361042+00:00",{"id":2155,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":337,"unit":1951,"count":2156,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177522,46292,"2024-08-29T18:32:38.705671+00:00",{"id":2159,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":338,"unit":1951,"count":2160,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190213,4868,"2024-08-29T18:32:42.512243+00:00",{"id":2163,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":339,"unit":1951,"count":2164,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202946,27293,"2024-08-29T18:32:47.819873+00:00",{"id":2167,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":340,"unit":1951,"count":2168,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215693,20625,"2024-08-29T18:32:51.625906+00:00",{"id":2171,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":341,"unit":1951,"count":2172,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228363,38562,"2024-08-29T18:32:55.901092+00:00",{"id":2175,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":342,"unit":1951,"count":2176,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241159,22,"2024-08-29T18:33:00.718637+00:00",{"id":2179,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":343,"unit":1951,"count":2180,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253955,23573,"2024-08-29T18:33:04.361217+00:00",{"id":2183,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":344,"unit":1951,"count":2184,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266709,32224,"2024-08-29T18:33:08.262239+00:00",{"id":2187,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":345,"unit":1951,"count":2188,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279533,936,"2024-08-29T18:33:11.715858+00:00",{"id":2191,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":346,"unit":1951,"count":2192,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292329,25387,"2024-08-29T18:33:14.517075+00:00",{"id":2195,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":347,"unit":1951,"count":2196,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305146,26652,"2024-08-29T18:33:17.36677+00:00",{"id":2199,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":348,"unit":1951,"count":2200,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445825,23515,"2024-08-29T18:41:46.886064+00:00",{"id":2203,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":349,"unit":1951,"count":2204,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458593,57767,"2024-08-29T18:41:53.668166+00:00",{"id":2207,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":350,"unit":1951,"count":2208,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471375,41037,"2024-08-29T18:41:58.957299+00:00",{"id":2211,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":351,"unit":1951,"count":2212,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484150,40930,"2024-08-29T18:42:02.832132+00:00",{"id":2215,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":352,"unit":1951,"count":2216,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496946,21065,"2024-08-29T18:42:07.013277+00:00",{"id":2219,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":353,"unit":1951,"count":2220,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547878,20795,"2024-09-19T17:06:09.52582+00:00",{"id":2223,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":354,"unit":1951,"count":2224,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624290,47276,"2024-10-14T19:25:44.92252+00:00",{"id":2227,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":355,"unit":1951,"count":2228,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711622,62291,"2024-11-15T12:02:15.592056+00:00",{"id":2231,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":356,"unit":1951,"count":2232,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737018,17058,"2024-12-13T11:12:20.991682+00:00",{"id":2235,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":357,"unit":1951,"count":2236,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762498,45072,"2025-01-14T11:40:52.21665+00:00",{"id":2239,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":358,"unit":1951,"count":2240,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788139,40004,"2025-02-14T14:30:01.389716+00:00",{"id":2243,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":359,"unit":1951,"count":2244,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813780,29247,"2025-03-14T18:58:27.965087+00:00",{"id":2247,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":360,"unit":1951,"count":2248,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839288,38186,"2025-04-18T11:30:22.691137+00:00",{"id":2251,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":361,"unit":1951,"count":2252,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864782,69389,"2025-05-16T12:14:17.071595+00:00",{"id":2255,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":362,"unit":1951,"count":2256,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890290,50515,"2025-06-14T01:41:21.727791+00:00",{"id":2259,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":363,"unit":1951,"count":2260,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915658,42026,"2025-07-14T19:06:44.052087+00:00",{"id":2263,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":364,"unit":1951,"count":2264,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940928,38813,"2025-08-16T12:25:00.603288+00:00",{"id":2267,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":365,"unit":1951,"count":2268,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966366,13729,"2025-09-12T11:42:37.894191+00:00",{"id":2271,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":366,"unit":1951,"count":2272,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991881,33877,"2025-10-14T11:42:56.875168+00:00",{"id":2275,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":367,"unit":1951,"count":2276,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017312,106453,"2025-11-14T12:42:07.365681+00:00",{"id":2279,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":368,"unit":1951,"count":2280,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042708,25293,"2025-12-12T11:35:22.979221+00:00",{"id":2283,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":369,"unit":1951,"count":2284,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068146,11533,"2026-01-16T14:46:13.606031+00:00",{"id":2287,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":370,"unit":1951,"count":2288,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093612,26412,"2026-02-16T12:06:53.151319+00:00",{"id":2291,"stats_class_code":378,"stats_class_code2":375,"stats_class_code3":185,"time":371,"unit":1951,"count":2292,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119106,42852,"2026-03-16T13:32:29.818135+00:00",{"code2_name":717,"code2":718,"items":2295},[2296],{"code1_name":374,"code1":378,"data":2297},{"201901":2298,"201902":2300,"201903":2303,"201904":2305,"201905":2308,"201906":2310,"201907":2312,"201908":2314,"201909":2317,"201910":2320,"201911":2322,"201912":2325,"202001":2327,"202002":2329,"202003":2332,"202004":2334,"202005":2336,"202006":2338,"202007":2341,"202008":2343,"202009":2346,"202010":2348,"202011":2350,"202012":2353,"202101":2356,"202102":2358,"202103":2360,"202104":2362,"202105":2364,"202106":2366,"202107":2369,"202108":2372,"202109":2374,"202110":2376,"202111":2378,"202112":2380,"202201":2382,"202202":2384,"202203":2386,"202204":2388,"202205":2390,"202206":2392,"202207":2394,"202208":2396,"202209":2398,"202210":2400,"202211":2402,"202212":2404,"202301":2406,"202302":2408,"202303":2410,"202304":2412,"202305":2414,"202306":2416,"202307":2418,"202308":2420,"202309":2422,"202310":2424,"202311":2426,"202312":2428,"202401":2430,"202402":2432,"202403":2434,"202404":2436,"202405":2438,"202406":2440,"202407":2442,"202408":2444,"202409":2446,"202410":2448,"202411":2450,"202412":2452,"202501":2454,"202502":2456,"202503":2458,"202504":2460,"202505":2462,"202506":2464,"202507":2466,"202508":2468,"202509":2470,"202510":2472,"202511":2474,"202512":2476},{"id":2299,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":288,"unit":1951,"count":1960,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639539,{"id":2301,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":289,"unit":1951,"count":2302,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651502,11156,{"id":2304,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":290,"unit":1951,"count":1968,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663696,{"id":2306,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":291,"unit":1951,"count":2307,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675918,20042,{"id":2309,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":292,"unit":1951,"count":1976,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688112,{"id":2311,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":293,"unit":1951,"count":1980,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700320,{"id":2313,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":294,"unit":1951,"count":1984,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712598,{"id":2315,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":295,"unit":1951,"count":2316,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724932,11407,{"id":2318,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":296,"unit":1951,"count":2319,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737224,6306,{"id":2321,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":297,"unit":1951,"count":1996,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749537,{"id":2323,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":298,"unit":1951,"count":2324,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774163,15655,{"id":2326,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":299,"unit":1951,"count":2004,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761815,{"id":2328,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":300,"unit":1951,"count":2008,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253348,{"id":2330,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":301,"unit":1951,"count":2331,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265605,9158,{"id":2333,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":302,"unit":1951,"count":2016,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278051,{"id":2335,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":303,"unit":1951,"count":2020,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289349,{"id":2337,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":304,"unit":1951,"count":2024,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301725,{"id":2339,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":305,"unit":1951,"count":2340,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314024,10263,{"id":2342,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":306,"unit":1951,"count":2032,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326414,{"id":2344,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":307,"unit":1951,"count":2345,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338853,21984,{"id":2347,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":308,"unit":1951,"count":2040,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351271,{"id":2349,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":309,"unit":1951,"count":2044,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363787,{"id":2351,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":310,"unit":1951,"count":2352,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376156,33016,{"id":2354,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":311,"unit":1951,"count":2355,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388539,6077,{"id":2357,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":312,"unit":1951,"count":2056,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549301,{"id":2359,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":313,"unit":1951,"count":2060,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561537,{"id":2361,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":314,"unit":1951,"count":2064,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574032,{"id":2363,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":315,"unit":1951,"count":2068,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586625,{"id":2365,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":316,"unit":1951,"count":2072,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599071,{"id":2367,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":317,"unit":1951,"count":2368,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611356,20399,{"id":2370,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":318,"unit":1951,"count":2371,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623592,29149,{"id":2373,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":319,"unit":1951,"count":2084,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635954,{"id":2375,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":320,"unit":1951,"count":2088,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648344,{"id":2377,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":321,"unit":1951,"count":2092,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660839,{"id":2379,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":322,"unit":1951,"count":2096,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673166,{"id":2381,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":323,"unit":1951,"count":2100,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685542,{"id":2383,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":324,"unit":1951,"count":2104,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998792,{"id":2385,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":325,"unit":1951,"count":2108,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986465,{"id":2387,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":326,"unit":1951,"count":2112,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973991,{"id":2389,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":327,"unit":1951,"count":2116,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961468,{"id":2391,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":328,"unit":1951,"count":2120,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948910,{"id":2393,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":329,"unit":1951,"count":2124,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936380,{"id":2395,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":330,"unit":1951,"count":2128,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923822,{"id":2397,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":331,"unit":1951,"count":2132,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911327,{"id":2399,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":332,"unit":1951,"count":2136,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898678,{"id":2401,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":333,"unit":1951,"count":2140,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886064,{"id":2403,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":334,"unit":1951,"count":2144,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873478,{"id":2405,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":335,"unit":1951,"count":2148,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860829,{"id":2407,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":336,"unit":1951,"count":2152,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164818,{"id":2409,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":337,"unit":1951,"count":2156,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177523,{"id":2411,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":338,"unit":1951,"count":2160,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190214,{"id":2413,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":339,"unit":1951,"count":2164,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202947,{"id":2415,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":340,"unit":1951,"count":2168,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215694,{"id":2417,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":341,"unit":1951,"count":2172,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228364,{"id":2419,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":342,"unit":1951,"count":2176,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241160,{"id":2421,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":343,"unit":1951,"count":2180,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253956,{"id":2423,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":344,"unit":1951,"count":2184,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266710,{"id":2425,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":345,"unit":1951,"count":2188,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279534,{"id":2427,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":346,"unit":1951,"count":2192,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292330,{"id":2429,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":347,"unit":1951,"count":2196,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305147,{"id":2431,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":348,"unit":1951,"count":2200,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445826,{"id":2433,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":349,"unit":1951,"count":2204,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458594,{"id":2435,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":350,"unit":1951,"count":2208,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471376,{"id":2437,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":351,"unit":1951,"count":2212,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484151,{"id":2439,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":352,"unit":1951,"count":2216,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496947,{"id":2441,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":353,"unit":1951,"count":2220,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547879,{"id":2443,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":354,"unit":1951,"count":2224,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624291,{"id":2445,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":355,"unit":1951,"count":2228,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711623,{"id":2447,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":356,"unit":1951,"count":2232,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737019,{"id":2449,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":357,"unit":1951,"count":2236,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762499,{"id":2451,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":358,"unit":1951,"count":2240,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788140,{"id":2453,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":359,"unit":1951,"count":2244,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813781,{"id":2455,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":360,"unit":1951,"count":2248,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839289,{"id":2457,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":361,"unit":1951,"count":2252,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864783,{"id":2459,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":362,"unit":1951,"count":2256,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890291,{"id":2461,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":363,"unit":1951,"count":2260,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915659,{"id":2463,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":364,"unit":1951,"count":2264,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940929,{"id":2465,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":365,"unit":1951,"count":2268,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966367,{"id":2467,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":366,"unit":1951,"count":2272,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991882,{"id":2469,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":367,"unit":1951,"count":2276,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017313,{"id":2471,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":368,"unit":1951,"count":2280,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042709,{"id":2473,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":369,"unit":1951,"count":2284,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068147,{"id":2475,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":370,"unit":1951,"count":2288,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093613,{"id":2477,"stats_class_code":378,"stats_class_code2":718,"stats_class_code3":185,"time":371,"unit":1951,"count":2292,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119107,{"code2_name":903,"code2":904,"items":2479},[2480],{"code1_name":374,"code1":378,"data":2481},{"201901":2482,"201902":2484,"201903":2487,"201904":2489,"201905":2492,"201906":2494,"201907":2496,"201908":2498,"201909":2501,"201910":2504,"201911":2506,"201912":2509,"202001":2511,"202002":2513,"202003":2515,"202004":2517,"202005":2519,"202006":2521,"202007":2524,"202008":2526,"202009":2529,"202010":2531,"202011":2533,"202012":2536,"202101":2539,"202102":2541,"202103":2543,"202104":2545,"202105":2547,"202106":2549,"202107":2552,"202108":2555,"202109":2557,"202110":2559,"202111":2561,"202112":2563,"202201":2565,"202202":2567,"202203":2569,"202204":2571,"202205":2573,"202206":2575,"202207":2577,"202208":2579,"202209":2581,"202210":2583,"202211":2585,"202212":2587,"202301":2589,"202302":2591,"202303":2593,"202304":2595,"202305":2597,"202306":2599,"202307":2601,"202308":2603,"202309":2605,"202310":2607,"202311":2609,"202312":2611,"202401":2613,"202402":2615,"202403":2617,"202404":2619,"202405":2621,"202406":2623,"202407":2625,"202408":2627,"202409":2629,"202410":2631,"202411":2633,"202412":2635,"202501":2637,"202502":2639,"202503":2641,"202504":2643,"202505":2645,"202506":2647,"202507":2649,"202508":2651,"202509":2653,"202510":2655,"202511":2657,"202512":2659},{"id":2483,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":288,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639540,{"id":2485,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":289,"unit":1951,"count":2486,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651503,1977,{"id":2488,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":290,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663697,{"id":2490,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":291,"unit":1951,"count":2491,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675919,28092,{"id":2493,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":292,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688113,{"id":2495,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":293,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700321,{"id":2497,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":294,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712599,{"id":2499,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":295,"unit":1951,"count":2500,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724933,25,{"id":2502,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":296,"unit":1951,"count":2503,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737225,25802,{"id":2505,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":297,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749538,{"id":2507,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":298,"unit":1951,"count":2508,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774164,13838,{"id":2510,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":299,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761816,{"id":2512,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":300,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253349,{"id":2514,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":301,"unit":1951,"count":1964,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265606,{"id":2516,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":302,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278052,{"id":2518,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":303,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289350,{"id":2520,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":304,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301726,{"id":2522,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":305,"unit":1951,"count":2523,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314025,23788,{"id":2525,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":306,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326415,{"id":2527,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":307,"unit":1951,"count":2528,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338854,6380,{"id":2530,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":308,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351272,{"id":2532,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":309,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363788,{"id":2534,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":310,"unit":1951,"count":2535,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376157,10600,{"id":2537,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":311,"unit":1951,"count":2538,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388540,16442,{"id":2540,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":312,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549302,{"id":2542,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":313,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561538,{"id":2544,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":314,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574033,{"id":2546,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":315,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586626,{"id":2548,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":316,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599072,{"id":2550,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":317,"unit":1951,"count":2551,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611357,13925,{"id":2553,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":318,"unit":1951,"count":2554,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623593,2484,{"id":2556,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":319,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635955,{"id":2558,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":320,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648345,{"id":2560,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":321,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660840,{"id":2562,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":322,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673167,{"id":2564,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":323,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685543,{"id":2566,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":324,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998793,{"id":2568,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":325,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986466,{"id":2570,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":326,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973992,{"id":2572,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":327,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961469,{"id":2574,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":328,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948911,{"id":2576,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":329,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936381,{"id":2578,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":330,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923823,{"id":2580,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":331,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911328,{"id":2582,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":332,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898679,{"id":2584,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":333,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886065,{"id":2586,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":334,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873479,{"id":2588,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":335,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860830,{"id":2590,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":336,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164819,{"id":2592,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":337,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177524,{"id":2594,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":338,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190215,{"id":2596,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":339,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202948,{"id":2598,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":340,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215695,{"id":2600,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":341,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228365,{"id":2602,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":342,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241161,{"id":2604,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":343,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253957,{"id":2606,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":344,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266711,{"id":2608,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":345,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279535,{"id":2610,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":346,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292331,{"id":2612,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":347,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305148,{"id":2614,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":348,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445827,{"id":2616,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":349,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458595,{"id":2618,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":350,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471377,{"id":2620,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":351,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484152,{"id":2622,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":352,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496948,{"id":2624,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":353,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547880,{"id":2626,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":354,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624292,{"id":2628,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":355,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711624,{"id":2630,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":356,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737020,{"id":2632,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":357,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762500,{"id":2634,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":358,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788141,{"id":2636,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":359,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813782,{"id":2638,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":360,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839290,{"id":2640,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":361,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864784,{"id":2642,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":362,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890292,{"id":2644,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":363,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915660,{"id":2646,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":364,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940930,{"id":2648,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":365,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966368,{"id":2650,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":366,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991883,{"id":2652,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":367,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017314,{"id":2654,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":368,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042710,{"id":2656,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":369,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068148,{"id":2658,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":370,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093614,{"id":2660,"stats_class_code":378,"stats_class_code2":904,"stats_class_code3":185,"time":371,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119108,{"code2_name":1089,"code2":1090,"items":2662},[2663,2917,3088],{"code1_name":1093,"code1":1094,"data":2664},{"201901":2665,"201902":2668,"201903":2671,"201904":2674,"201905":2677,"201906":2680,"201907":2683,"201908":2686,"201909":2689,"201910":2692,"201911":2695,"201912":2698,"202001":2701,"202002":2704,"202003":2707,"202004":2710,"202005":2713,"202006":2716,"202007":2719,"202008":2722,"202009":2725,"202010":2728,"202011":2731,"202012":2734,"202101":2737,"202102":2740,"202103":2743,"202104":2746,"202105":2749,"202106":2752,"202107":2755,"202108":2758,"202109":2761,"202110":2764,"202111":2767,"202112":2770,"202201":2773,"202202":2776,"202203":2779,"202204":2782,"202205":2785,"202206":2788,"202207":2791,"202208":2794,"202209":2797,"202210":2800,"202211":2803,"202212":2806,"202301":2809,"202302":2812,"202303":2815,"202304":2818,"202305":2821,"202306":2824,"202307":2827,"202308":2830,"202309":2833,"202310":2836,"202311":2839,"202312":2842,"202401":2845,"202402":2848,"202403":2851,"202404":2854,"202405":2857,"202406":2860,"202407":2863,"202408":2866,"202409":2869,"202410":2872,"202411":2875,"202412":2878,"202501":2881,"202502":2884,"202503":2887,"202504":2890,"202505":2893,"202506":2896,"202507":2899,"202508":2902,"202509":2905,"202510":2908,"202511":2911,"202512":2914},{"id":2666,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":288,"unit":1951,"count":2667,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639542,20549,{"id":2669,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":289,"unit":1951,"count":2670,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651505,22500,{"id":2672,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":290,"unit":1951,"count":2673,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663699,16089,{"id":2675,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":291,"unit":1951,"count":2676,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675921,17156,{"id":2678,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":292,"unit":1951,"count":2679,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688115,20499,{"id":2681,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":293,"unit":1951,"count":2682,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700323,19127,{"id":2684,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":294,"unit":1951,"count":2685,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712601,33801,{"id":2687,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":295,"unit":1951,"count":2688,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724935,17194,{"id":2690,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":296,"unit":1951,"count":2691,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737227,24129,{"id":2693,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":297,"unit":1951,"count":2694,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749540,21484,{"id":2696,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":298,"unit":1951,"count":2697,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774166,22681,{"id":2699,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":299,"unit":1951,"count":2700,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761818,20265,{"id":2702,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":300,"unit":1951,"count":2703,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253351,23399,{"id":2705,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":301,"unit":1951,"count":2706,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265608,19574,{"id":2708,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":302,"unit":1951,"count":2709,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278054,12609,{"id":2711,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":303,"unit":1951,"count":2712,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289352,16713,{"id":2714,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":304,"unit":1951,"count":2715,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301728,14887,{"id":2717,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":305,"unit":1951,"count":2718,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314027,23419,{"id":2720,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":306,"unit":1951,"count":2721,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326417,28384,{"id":2723,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":307,"unit":1951,"count":2724,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338856,17687,{"id":2726,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":308,"unit":1951,"count":2727,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351274,21993,{"id":2729,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":309,"unit":1951,"count":2730,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363790,30836,{"id":2732,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":310,"unit":1951,"count":2733,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376159,29696,{"id":2735,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":311,"unit":1951,"count":2736,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388542,24670,{"id":2738,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":312,"unit":1951,"count":2739,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549304,24837,{"id":2741,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":313,"unit":1951,"count":2742,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561540,24755,{"id":2744,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":314,"unit":1951,"count":2745,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574035,13845,{"id":2747,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":315,"unit":1951,"count":2748,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586628,21436,{"id":2750,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":316,"unit":1951,"count":2751,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599074,82159,{"id":2753,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":317,"unit":1951,"count":2754,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611359,40623,{"id":2756,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":318,"unit":1951,"count":2757,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623595,42920,{"id":2759,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":319,"unit":1951,"count":2760,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635957,46065,{"id":2762,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":320,"unit":1951,"count":2763,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648347,45538,{"id":2765,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":321,"unit":1951,"count":2766,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660842,28912,{"id":2768,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":322,"unit":1951,"count":2769,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673169,28490,{"id":2771,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":323,"unit":1951,"count":2772,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685545,25252,{"id":2774,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":324,"unit":1951,"count":2775,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998795,39114,{"id":2777,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":325,"unit":1951,"count":2778,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986468,44661,{"id":2780,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":326,"unit":1951,"count":2781,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973994,49522,{"id":2783,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":327,"unit":1951,"count":2784,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961471,26981,{"id":2786,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":328,"unit":1951,"count":2787,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948913,25653,{"id":2789,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":329,"unit":1951,"count":2790,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936383,41675,{"id":2792,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":330,"unit":1951,"count":2793,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923825,26301,{"id":2795,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":331,"unit":1951,"count":2796,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911330,49216,{"id":2798,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":332,"unit":1951,"count":2799,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898681,21977,{"id":2801,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":333,"unit":1951,"count":2802,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886067,23584,{"id":2804,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":334,"unit":1951,"count":2805,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873481,28290,{"id":2807,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":335,"unit":1951,"count":2808,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860832,18623,{"id":2810,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":336,"unit":1951,"count":2811,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164821,25981,{"id":2813,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":337,"unit":1951,"count":2814,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177526,45076,{"id":2816,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":338,"unit":1951,"count":2817,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190217,36013,{"id":2819,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":339,"unit":1951,"count":2820,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202950,23560,{"id":2822,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":340,"unit":1951,"count":2823,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215697,24050,{"id":2825,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":341,"unit":1951,"count":2826,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228367,26662,{"id":2828,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":342,"unit":1951,"count":2829,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241163,26018,{"id":2831,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":343,"unit":1951,"count":2832,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253959,47541,{"id":2834,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":344,"unit":1951,"count":2835,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266713,33158,{"id":2837,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":345,"unit":1951,"count":2838,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279537,27256,{"id":2840,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":346,"unit":1951,"count":2841,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292333,23445,{"id":2843,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":347,"unit":1951,"count":2844,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305150,21319,{"id":2846,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":348,"unit":1951,"count":2847,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445829,28321,{"id":2849,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":349,"unit":1951,"count":2850,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458597,26333,{"id":2852,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":350,"unit":1951,"count":2853,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471379,68051,{"id":2855,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":351,"unit":1951,"count":2856,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484154,68222,{"id":2858,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":352,"unit":1951,"count":2859,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496950,28322,{"id":2861,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":353,"unit":1951,"count":2862,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547882,29060,{"id":2864,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":354,"unit":1951,"count":2865,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624294,35152,{"id":2867,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":355,"unit":1951,"count":2868,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711626,54707,{"id":2870,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":356,"unit":1951,"count":2871,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737022,50165,{"id":2873,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":357,"unit":1951,"count":2874,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762502,35561,{"id":2876,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":358,"unit":1951,"count":2877,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788143,28771,{"id":2879,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":359,"unit":1951,"count":2880,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813784,27305,{"id":2882,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":360,"unit":1951,"count":2883,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839292,32157,{"id":2885,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":361,"unit":1951,"count":2886,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864786,63088,{"id":2888,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":362,"unit":1951,"count":2889,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890294,54503,{"id":2891,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":363,"unit":1951,"count":2892,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915662,31103,{"id":2894,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":364,"unit":1951,"count":2895,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940932,32618,{"id":2897,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":365,"unit":1951,"count":2898,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966370,36555,{"id":2900,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":366,"unit":1951,"count":2901,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991885,38152,{"id":2903,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":367,"unit":1951,"count":2904,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017316,65991,{"id":2906,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":368,"unit":1951,"count":2907,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042712,55336,{"id":2909,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":369,"unit":1951,"count":2910,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068150,29468,{"id":2912,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":370,"unit":1951,"count":2913,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093616,27397,{"id":2915,"stats_class_code":1094,"stats_class_code2":1090,"stats_class_code3":185,"time":371,"unit":1951,"count":2916,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119110,27464,{"code1_name":1344,"code1":1345,"data":2918},{"201901":2919,"201902":2921,"201903":2923,"201904":2925,"201905":2927,"201906":2929,"201907":2931,"201908":2933,"201909":2935,"201910":2937,"201911":2939,"201912":2941,"202001":2943,"202002":2945,"202003":2947,"202004":2950,"202005":2952,"202006":2954,"202007":2956,"202008":2958,"202009":2960,"202010":2962,"202011":2964,"202012":2966,"202101":2968,"202102":2970,"202103":2972,"202104":2974,"202105":2976,"202106":2978,"202107":2980,"202108":2982,"202109":2984,"202110":2986,"202111":2988,"202112":2990,"202201":2992,"202202":2994,"202203":2996,"202204":2998,"202205":3000,"202206":3002,"202207":3004,"202208":3006,"202209":3008,"202210":3010,"202211":3012,"202212":3014,"202301":3016,"202302":3018,"202303":3020,"202304":3022,"202305":3024,"202306":3026,"202307":3028,"202308":3030,"202309":3032,"202310":3034,"202311":3036,"202312":3038,"202401":3040,"202402":3042,"202403":3044,"202404":3046,"202405":3048,"202406":3050,"202407":3052,"202408":3054,"202409":3056,"202410":3058,"202411":3060,"202412":3062,"202501":3064,"202502":3066,"202503":3068,"202504":3070,"202505":3072,"202506":3074,"202507":3076,"202508":3078,"202509":3080,"202510":3082,"202511":3084,"202512":3086},{"id":2920,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":288,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639543,{"id":2922,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":289,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651506,{"id":2924,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":290,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663700,{"id":2926,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":291,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675922,{"id":2928,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":292,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688116,{"id":2930,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":293,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700324,{"id":2932,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":294,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712602,{"id":2934,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":295,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724936,{"id":2936,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":296,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737228,{"id":2938,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":297,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749541,{"id":2940,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":298,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774167,{"id":2942,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":299,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761819,{"id":2944,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":300,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253352,{"id":2946,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":301,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265609,{"id":2948,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":302,"unit":1951,"count":2949,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278055,1238,{"id":2951,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":303,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289353,{"id":2953,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":304,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301729,{"id":2955,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":305,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314028,{"id":2957,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":306,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326418,{"id":2959,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":307,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338857,{"id":2961,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":308,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351275,{"id":2963,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":309,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363791,{"id":2965,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":310,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376160,{"id":2967,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":311,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388543,{"id":2969,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":312,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549305,{"id":2971,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":313,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561541,{"id":2973,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":314,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574036,{"id":2975,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":315,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586629,{"id":2977,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":316,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599075,{"id":2979,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":317,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611360,{"id":2981,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":318,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623596,{"id":2983,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":319,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635958,{"id":2985,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":320,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648348,{"id":2987,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":321,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660843,{"id":2989,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":322,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673170,{"id":2991,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":323,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685546,{"id":2993,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":324,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998796,{"id":2995,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":325,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986469,{"id":2997,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":326,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973995,{"id":2999,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":327,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961472,{"id":3001,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":328,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948914,{"id":3003,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":329,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936384,{"id":3005,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":330,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923826,{"id":3007,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":331,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911331,{"id":3009,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":332,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898682,{"id":3011,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":333,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886068,{"id":3013,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":334,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873482,{"id":3015,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":335,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860833,{"id":3017,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":336,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164822,{"id":3019,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":337,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177527,{"id":3021,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":338,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190218,{"id":3023,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":339,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202951,{"id":3025,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":340,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215698,{"id":3027,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":341,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228368,{"id":3029,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":342,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241164,{"id":3031,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":343,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253960,{"id":3033,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":344,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266714,{"id":3035,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":345,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279538,{"id":3037,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":346,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292334,{"id":3039,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":347,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305151,{"id":3041,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":348,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445830,{"id":3043,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":349,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458598,{"id":3045,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":350,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471380,{"id":3047,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":351,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484155,{"id":3049,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":352,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496951,{"id":3051,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":353,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547883,{"id":3053,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":354,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624295,{"id":3055,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":355,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711627,{"id":3057,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":356,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737023,{"id":3059,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":357,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762503,{"id":3061,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":358,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788144,{"id":3063,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":359,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813785,{"id":3065,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":360,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839293,{"id":3067,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":361,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864787,{"id":3069,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":362,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890295,{"id":3071,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":363,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915663,{"id":3073,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":364,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940933,{"id":3075,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":365,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966371,{"id":3077,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":366,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991886,{"id":3079,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":367,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017317,{"id":3081,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":368,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042713,{"id":3083,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":369,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068151,{"id":3085,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":370,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093617,{"id":3087,"stats_class_code":1345,"stats_class_code2":1090,"stats_class_code3":185,"time":371,"unit":1951,"count":185,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119111,{"code1_name":374,"code1":378,"data":3089},{"201901":3090,"201902":3092,"201903":3094,"201904":3096,"201905":3098,"201906":3100,"201907":3102,"201908":3104,"201909":3106,"201910":3108,"201911":3110,"201912":3112,"202001":3114,"202002":3116,"202003":3118,"202004":3121,"202005":3123,"202006":3125,"202007":3127,"202008":3129,"202009":3131,"202010":3133,"202011":3135,"202012":3137,"202101":3139,"202102":3141,"202103":3143,"202104":3145,"202105":3147,"202106":3149,"202107":3151,"202108":3153,"202109":3155,"202110":3157,"202111":3159,"202112":3161,"202201":3163,"202202":3165,"202203":3167,"202204":3169,"202205":3171,"202206":3173,"202207":3175,"202208":3177,"202209":3179,"202210":3181,"202211":3183,"202212":3185,"202301":3187,"202302":3189,"202303":3191,"202304":3193,"202305":3195,"202306":3197,"202307":3199,"202308":3201,"202309":3203,"202310":3205,"202311":3207,"202312":3209,"202401":3211,"202402":3213,"202403":3215,"202404":3217,"202405":3219,"202406":3221,"202407":3223,"202408":3225,"202409":3227,"202410":3229,"202411":3231,"202412":3233,"202501":3235,"202502":3237,"202503":3239,"202504":3241,"202505":3243,"202506":3245,"202507":3247,"202508":3249,"202509":3251,"202510":3253,"202511":3255,"202512":3257},{"id":3091,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":288,"unit":1951,"count":2667,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639541,{"id":3093,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":289,"unit":1951,"count":2670,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651504,{"id":3095,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":290,"unit":1951,"count":2673,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663698,{"id":3097,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":291,"unit":1951,"count":2676,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675920,{"id":3099,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":292,"unit":1951,"count":2679,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688114,{"id":3101,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":293,"unit":1951,"count":2682,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700322,{"id":3103,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":294,"unit":1951,"count":2685,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712600,{"id":3105,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":295,"unit":1951,"count":2688,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724934,{"id":3107,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":296,"unit":1951,"count":2691,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737226,{"id":3109,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":297,"unit":1951,"count":2694,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749539,{"id":3111,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":298,"unit":1951,"count":2697,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774165,{"id":3113,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":299,"unit":1951,"count":2700,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761817,{"id":3115,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":300,"unit":1951,"count":2703,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253350,{"id":3117,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":301,"unit":1951,"count":2706,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265607,{"id":3119,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":302,"unit":1951,"count":3120,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278053,13847,{"id":3122,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":303,"unit":1951,"count":2712,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289351,{"id":3124,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":304,"unit":1951,"count":2715,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301727,{"id":3126,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":305,"unit":1951,"count":2718,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314026,{"id":3128,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":306,"unit":1951,"count":2721,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326416,{"id":3130,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":307,"unit":1951,"count":2724,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338855,{"id":3132,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":308,"unit":1951,"count":2727,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351273,{"id":3134,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":309,"unit":1951,"count":2730,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363789,{"id":3136,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":310,"unit":1951,"count":2733,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376158,{"id":3138,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":311,"unit":1951,"count":2736,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388541,{"id":3140,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":312,"unit":1951,"count":2739,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549303,{"id":3142,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":313,"unit":1951,"count":2742,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561539,{"id":3144,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":314,"unit":1951,"count":2745,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574034,{"id":3146,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":315,"unit":1951,"count":2748,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586627,{"id":3148,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":316,"unit":1951,"count":2751,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599073,{"id":3150,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":317,"unit":1951,"count":2754,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611358,{"id":3152,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":318,"unit":1951,"count":2757,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623594,{"id":3154,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":319,"unit":1951,"count":2760,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635956,{"id":3156,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":320,"unit":1951,"count":2763,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648346,{"id":3158,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":321,"unit":1951,"count":2766,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660841,{"id":3160,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":322,"unit":1951,"count":2769,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673168,{"id":3162,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":323,"unit":1951,"count":2772,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685544,{"id":3164,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":324,"unit":1951,"count":2775,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998794,{"id":3166,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":325,"unit":1951,"count":2778,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986467,{"id":3168,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":326,"unit":1951,"count":2781,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973993,{"id":3170,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":327,"unit":1951,"count":2784,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961470,{"id":3172,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":328,"unit":1951,"count":2787,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948912,{"id":3174,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":329,"unit":1951,"count":2790,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936382,{"id":3176,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":330,"unit":1951,"count":2793,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923824,{"id":3178,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":331,"unit":1951,"count":2796,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911329,{"id":3180,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":332,"unit":1951,"count":2799,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898680,{"id":3182,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":333,"unit":1951,"count":2802,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886066,{"id":3184,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":334,"unit":1951,"count":2805,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873480,{"id":3186,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":335,"unit":1951,"count":2808,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860831,{"id":3188,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":336,"unit":1951,"count":2811,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164820,{"id":3190,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":337,"unit":1951,"count":2814,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177525,{"id":3192,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":338,"unit":1951,"count":2817,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190216,{"id":3194,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":339,"unit":1951,"count":2820,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202949,{"id":3196,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":340,"unit":1951,"count":2823,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215696,{"id":3198,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":341,"unit":1951,"count":2826,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228366,{"id":3200,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":342,"unit":1951,"count":2829,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241162,{"id":3202,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":343,"unit":1951,"count":2832,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253958,{"id":3204,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":344,"unit":1951,"count":2835,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266712,{"id":3206,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":345,"unit":1951,"count":2838,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279536,{"id":3208,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":346,"unit":1951,"count":2841,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292332,{"id":3210,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":347,"unit":1951,"count":2844,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305149,{"id":3212,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":348,"unit":1951,"count":2847,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445828,{"id":3214,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":349,"unit":1951,"count":2850,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458596,{"id":3216,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":350,"unit":1951,"count":2853,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471378,{"id":3218,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":351,"unit":1951,"count":2856,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484153,{"id":3220,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":352,"unit":1951,"count":2859,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496949,{"id":3222,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":353,"unit":1951,"count":2862,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547881,{"id":3224,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":354,"unit":1951,"count":2865,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624293,{"id":3226,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":355,"unit":1951,"count":2868,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711625,{"id":3228,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":356,"unit":1951,"count":2871,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737021,{"id":3230,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":357,"unit":1951,"count":2874,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762501,{"id":3232,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":358,"unit":1951,"count":2877,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788142,{"id":3234,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":359,"unit":1951,"count":2880,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813783,{"id":3236,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":360,"unit":1951,"count":2883,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839291,{"id":3238,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":361,"unit":1951,"count":2886,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864785,{"id":3240,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":362,"unit":1951,"count":2889,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890293,{"id":3242,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":363,"unit":1951,"count":2892,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915661,{"id":3244,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":364,"unit":1951,"count":2895,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940931,{"id":3246,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":365,"unit":1951,"count":2898,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966369,{"id":3248,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":366,"unit":1951,"count":2901,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991884,{"id":3250,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":367,"unit":1951,"count":2904,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017315,{"id":3252,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":368,"unit":1951,"count":2907,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042711,{"id":3254,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":369,"unit":1951,"count":2910,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068149,{"id":3256,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":370,"unit":1951,"count":2913,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093615,{"id":3258,"stats_class_code":378,"stats_class_code2":1090,"stats_class_code3":185,"time":371,"unit":1951,"count":2916,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119109,{"code2_name":1688,"code2":1689,"items":3260},[3261],{"code1_name":374,"code1":378,"data":3262},{"201901":3263,"201902":3266,"201903":3269,"201904":3272,"201905":3275,"201906":3278,"201907":3281,"201908":3284,"201909":3287,"201910":3290,"201911":3293,"201912":3296,"202001":3299,"202002":3302,"202003":3305,"202004":3308,"202005":3311,"202006":3314,"202007":3317,"202008":3320,"202009":3323,"202010":3326,"202011":3329,"202012":3332,"202101":3335,"202102":3338,"202103":3341,"202104":3344,"202105":3347,"202106":3350,"202107":3353,"202108":3356,"202109":3359,"202110":3362,"202111":3365,"202112":3368,"202201":3371,"202202":3374,"202203":3377,"202204":3380,"202205":3383,"202206":3386,"202207":3389,"202208":3392,"202209":3395,"202210":3398,"202211":3401,"202212":3404,"202301":3407,"202302":3410,"202303":3413,"202304":3416,"202305":3419,"202306":3422,"202307":3425,"202308":3428,"202309":3431,"202310":3434,"202311":3437,"202312":3440,"202401":3443,"202402":3446,"202403":3449,"202404":3452,"202405":3455,"202406":3458,"202407":3461,"202408":3464,"202409":3467,"202410":3470,"202411":3473,"202412":3476,"202501":3479,"202502":3482,"202503":3485,"202504":3488,"202505":3491,"202506":3494,"202507":3497,"202508":3500,"202509":3503,"202510":3506,"202511":3509,"202512":3512},{"id":3264,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":288,"unit":1951,"count":3265,"stats_id":204,"stats_item_id":1950,"inserted_at":1961},639544,50855,{"id":3267,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":289,"unit":1951,"count":3268,"stats_id":204,"stats_item_id":1950,"inserted_at":1965},651507,38180,{"id":3270,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":290,"unit":1951,"count":3271,"stats_id":204,"stats_item_id":1950,"inserted_at":1969},663701,46039,{"id":3273,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":291,"unit":1951,"count":3274,"stats_id":204,"stats_item_id":1950,"inserted_at":1973},675923,73967,{"id":3276,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":292,"unit":1951,"count":3277,"stats_id":204,"stats_item_id":1950,"inserted_at":1977},688117,89394,{"id":3279,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":293,"unit":1951,"count":3280,"stats_id":204,"stats_item_id":1950,"inserted_at":1981},700325,125280,{"id":3282,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":294,"unit":1951,"count":3283,"stats_id":204,"stats_item_id":1950,"inserted_at":1985},712603,102023,{"id":3285,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":295,"unit":1951,"count":3286,"stats_id":204,"stats_item_id":1950,"inserted_at":1989},724937,97860,{"id":3288,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":296,"unit":1951,"count":3289,"stats_id":204,"stats_item_id":1950,"inserted_at":1993},737229,69363,{"id":3291,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":297,"unit":1951,"count":3292,"stats_id":204,"stats_item_id":1950,"inserted_at":1997},749542,92067,{"id":3294,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":298,"unit":1951,"count":3295,"stats_id":204,"stats_item_id":1950,"inserted_at":2001},774168,96098,{"id":3297,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":299,"unit":1951,"count":3298,"stats_id":204,"stats_item_id":1950,"inserted_at":2005},761820,84690,{"id":3300,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":300,"unit":1951,"count":3301,"stats_id":204,"stats_item_id":1950,"inserted_at":2009},1253353,75739,{"id":3303,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":301,"unit":1951,"count":3304,"stats_id":204,"stats_item_id":1950,"inserted_at":2013},1265610,57177,{"id":3306,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":302,"unit":1951,"count":3307,"stats_id":204,"stats_item_id":1950,"inserted_at":2017},1278056,87868,{"id":3309,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":303,"unit":1951,"count":3310,"stats_id":204,"stats_item_id":1950,"inserted_at":2021},1289354,94186,{"id":3312,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":304,"unit":1951,"count":3313,"stats_id":204,"stats_item_id":1950,"inserted_at":2025},1301730,81576,{"id":3315,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":305,"unit":1951,"count":3316,"stats_id":204,"stats_item_id":1950,"inserted_at":2029},1314029,92285,{"id":3318,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":306,"unit":1951,"count":3319,"stats_id":204,"stats_item_id":1950,"inserted_at":2033},1326419,66840,{"id":3321,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":307,"unit":1951,"count":3322,"stats_id":204,"stats_item_id":1950,"inserted_at":2037},1338858,78798,{"id":3324,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":308,"unit":1951,"count":3325,"stats_id":204,"stats_item_id":1950,"inserted_at":2041},1351276,69027,{"id":3327,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":309,"unit":1951,"count":3328,"stats_id":204,"stats_item_id":1950,"inserted_at":2045},1363792,61294,{"id":3330,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":310,"unit":1951,"count":3331,"stats_id":204,"stats_item_id":1950,"inserted_at":2049},1376161,73874,{"id":3333,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":311,"unit":1951,"count":3334,"stats_id":204,"stats_item_id":1950,"inserted_at":2053},1388544,71563,{"id":3336,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":312,"unit":1951,"count":3337,"stats_id":204,"stats_item_id":1950,"inserted_at":2057},1549306,75930,{"id":3339,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":313,"unit":1951,"count":3340,"stats_id":204,"stats_item_id":1950,"inserted_at":2061},1561542,42040,{"id":3342,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":314,"unit":1951,"count":3343,"stats_id":204,"stats_item_id":1950,"inserted_at":2065},1574037,69777,{"id":3345,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":315,"unit":1951,"count":3346,"stats_id":204,"stats_item_id":1950,"inserted_at":2069},1586630,76843,{"id":3348,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":316,"unit":1951,"count":3349,"stats_id":204,"stats_item_id":1950,"inserted_at":2073},1599076,201490,{"id":3351,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":317,"unit":1951,"count":3352,"stats_id":204,"stats_item_id":1950,"inserted_at":2077},1611361,132677,{"id":3354,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":318,"unit":1951,"count":3355,"stats_id":204,"stats_item_id":1950,"inserted_at":2081},1623597,150087,{"id":3357,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":319,"unit":1951,"count":3358,"stats_id":204,"stats_item_id":1950,"inserted_at":2085},1635959,141052,{"id":3360,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":320,"unit":1951,"count":3361,"stats_id":204,"stats_item_id":1950,"inserted_at":2089},1648349,118150,{"id":3363,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":321,"unit":1951,"count":3364,"stats_id":204,"stats_item_id":1950,"inserted_at":2093},1660844,93251,{"id":3366,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":322,"unit":1951,"count":3367,"stats_id":204,"stats_item_id":1950,"inserted_at":2097},1673171,103973,{"id":3369,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":323,"unit":1951,"count":3370,"stats_id":204,"stats_item_id":1950,"inserted_at":2101},1685547,125632,{"id":3372,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":324,"unit":1951,"count":3373,"stats_id":204,"stats_item_id":1950,"inserted_at":2105},1998797,168764,{"id":3375,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":325,"unit":1951,"count":3376,"stats_id":204,"stats_item_id":1950,"inserted_at":2109},1986470,167011,{"id":3378,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":326,"unit":1951,"count":3379,"stats_id":204,"stats_item_id":1950,"inserted_at":2113},1973996,142216,{"id":3381,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":327,"unit":1951,"count":3382,"stats_id":204,"stats_item_id":1950,"inserted_at":2117},1961473,124328,{"id":3384,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":328,"unit":1951,"count":3385,"stats_id":204,"stats_item_id":1950,"inserted_at":2121},1948915,125154,{"id":3387,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":329,"unit":1951,"count":3388,"stats_id":204,"stats_item_id":1950,"inserted_at":2125},1936385,114938,{"id":3390,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":330,"unit":1951,"count":3391,"stats_id":204,"stats_item_id":1950,"inserted_at":2129},1923827,118360,{"id":3393,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":331,"unit":1951,"count":3394,"stats_id":204,"stats_item_id":1950,"inserted_at":2133},1911332,124449,{"id":3396,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":332,"unit":1951,"count":3397,"stats_id":204,"stats_item_id":1950,"inserted_at":2137},1898683,132756,{"id":3399,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":333,"unit":1951,"count":3400,"stats_id":204,"stats_item_id":1950,"inserted_at":2141},1886069,144327,{"id":3402,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":334,"unit":1951,"count":3403,"stats_id":204,"stats_item_id":1950,"inserted_at":2145},1873483,167805,{"id":3405,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":335,"unit":1951,"count":3406,"stats_id":204,"stats_item_id":1950,"inserted_at":2149},1860834,182045,{"id":3408,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":336,"unit":1951,"count":3409,"stats_id":204,"stats_item_id":1950,"inserted_at":2153},2164823,206666,{"id":3411,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":337,"unit":1951,"count":3412,"stats_id":204,"stats_item_id":1950,"inserted_at":2157},2177528,207901,{"id":3414,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":338,"unit":1951,"count":3415,"stats_id":204,"stats_item_id":1950,"inserted_at":2161},2190219,176895,{"id":3417,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":339,"unit":1951,"count":3418,"stats_id":204,"stats_item_id":1950,"inserted_at":2165},2202952,183186,{"id":3420,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":340,"unit":1951,"count":3421,"stats_id":204,"stats_item_id":1950,"inserted_at":2169},2215699,179713,{"id":3423,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":341,"unit":1951,"count":3424,"stats_id":204,"stats_item_id":1950,"inserted_at":2173},2228369,191612,{"id":3426,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":342,"unit":1951,"count":3427,"stats_id":204,"stats_item_id":1950,"inserted_at":2177},2241165,165552,{"id":3429,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":343,"unit":1951,"count":3430,"stats_id":204,"stats_item_id":1950,"inserted_at":2181},2253961,141542,{"id":3432,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":344,"unit":1951,"count":3433,"stats_id":204,"stats_item_id":1950,"inserted_at":2185},2266715,140563,{"id":3435,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":345,"unit":1951,"count":3436,"stats_id":204,"stats_item_id":1950,"inserted_at":2189},2279539,112156,{"id":3438,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":346,"unit":1951,"count":3439,"stats_id":204,"stats_item_id":1950,"inserted_at":2193},2292335,110136,{"id":3441,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":347,"unit":1951,"count":3442,"stats_id":204,"stats_item_id":1950,"inserted_at":2197},2305152,100578,{"id":3444,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":348,"unit":1951,"count":3445,"stats_id":204,"stats_item_id":1950,"inserted_at":2201},2445831,103446,{"id":3447,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":349,"unit":1951,"count":3448,"stats_id":204,"stats_item_id":1950,"inserted_at":2205},2458599,131776,{"id":3450,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":350,"unit":1951,"count":3451,"stats_id":204,"stats_item_id":1950,"inserted_at":2209},2471381,101475,{"id":3453,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":351,"unit":1951,"count":3454,"stats_id":204,"stats_item_id":1950,"inserted_at":2213},2484156,93973,{"id":3456,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":352,"unit":1951,"count":3457,"stats_id":204,"stats_item_id":1950,"inserted_at":2217},2496952,136327,{"id":3459,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":353,"unit":1951,"count":3460,"stats_id":204,"stats_item_id":1950,"inserted_at":2221},2547884,126913,{"id":3462,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":354,"unit":1951,"count":3463,"stats_id":204,"stats_item_id":1950,"inserted_at":2225},2624296,138955,{"id":3465,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":355,"unit":1951,"count":3466,"stats_id":204,"stats_item_id":1950,"inserted_at":2229},2711628,146352,{"id":3468,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":356,"unit":1951,"count":3469,"stats_id":204,"stats_item_id":1950,"inserted_at":2233},2737024,113150,{"id":3471,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":357,"unit":1951,"count":3472,"stats_id":204,"stats_item_id":1950,"inserted_at":2237},2762504,122563,{"id":3474,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":358,"unit":1951,"count":3475,"stats_id":204,"stats_item_id":1950,"inserted_at":2241},2788145,133729,{"id":3477,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":359,"unit":1951,"count":3478,"stats_id":204,"stats_item_id":1950,"inserted_at":2245},2813786,135643,{"id":3480,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":360,"unit":1951,"count":3481,"stats_id":204,"stats_item_id":1950,"inserted_at":2249},2839294,141628,{"id":3483,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":361,"unit":1951,"count":3484,"stats_id":204,"stats_item_id":1950,"inserted_at":2253},2864788,147832,{"id":3486,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":362,"unit":1951,"count":3487,"stats_id":204,"stats_item_id":1950,"inserted_at":2257},2890296,144244,{"id":3489,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":363,"unit":1951,"count":3490,"stats_id":204,"stats_item_id":1950,"inserted_at":2261},2915664,154957,{"id":3492,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":364,"unit":1951,"count":3493,"stats_id":204,"stats_item_id":1950,"inserted_at":2265},2940934,161089,{"id":3495,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":365,"unit":1951,"count":3496,"stats_id":204,"stats_item_id":1950,"inserted_at":2269},2966372,137655,{"id":3498,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":366,"unit":1951,"count":3499,"stats_id":204,"stats_item_id":1950,"inserted_at":2273},2991887,133309,{"id":3501,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":367,"unit":1951,"count":3502,"stats_id":204,"stats_item_id":1950,"inserted_at":2277},3017318,173733,{"id":3504,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":368,"unit":1951,"count":3505,"stats_id":204,"stats_item_id":1950,"inserted_at":2281},3042714,143593,{"id":3507,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":369,"unit":1951,"count":3508,"stats_id":204,"stats_item_id":1950,"inserted_at":2285},3068152,125623,{"id":3510,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":370,"unit":1951,"count":3511,"stats_id":204,"stats_item_id":1950,"inserted_at":2289},3093618,124511,{"id":3513,"stats_class_code":378,"stats_class_code2":1689,"stats_class_code3":185,"time":371,"unit":1951,"count":3514,"stats_id":204,"stats_item_id":1950,"inserted_at":2293},3119112,139832,[3516,3532,3546,3562,3575,3593,3605,3617,3629,3641,3655,3667,3681,3693,3705,3716,3728,3740,3756,3767,3778,3793,3804,3814,3826,3839,3851,3863,3875,3887,3896,3906,3917,3927,3936,3947,3958,3968,3979,3992,4003,4014,4026,4039,4050,4059,4068,4078,4091,4104,4117,4126,4137,4146,4156,4166,4178,4188,4199,4209,4218,4229,4242,4254,4267,4274,4285,4294,4305,4314,4322,4332,4341,4353,4361,4371,4384,4396,4407,4417,4428,4436,4445,4446,4455,4468,4479,4489,4500,4509,4519,4529,4538,4548,4559,4569,4579,4589,4598,4611,4620,4630,4640,4649,4659,4668,4677,4687,4696,4706,4716,4725,4735,4743,4750,4759,4769,4777,4787,4796,4806,4815,4824,4832,4840,4848,4856,4865,4871,4879,4885,4891,4897,4902,4908,4914,4920,4927,4933,4939,4946,4952,4958,4963,4969,4975,4981,4986,4991,4996,5002,5008,5014,5020,5026,5032,5038,5044,5051,5057,5062,5067,5074,5081,5087,5094,5100,5106,5111,5117,5123,5129,5136,5142,5148,5155,5161,5167,5174,5180,5186,5195,5201,5209,5216,5222,5230,5236,5242,5248,5255,5263,5269,5275,5281,5287,5293,5301,5307,5313,5319,5328,5334,5344,5351,5358,5364,5370,5376,5382,5388,5394,5400,5406,5412,5418,5425,5431,5438,5445,5451,5457,5462,5468,5474,5480,5486,5492,5498,5504,5510,5516,5522,5528,5534,5540,5546,5552,5558,5565,5572,5578,5585,5591,5597,5603,5609,5615,5622,5628,5634,5640,5646,5652,5658,5664,5669,5675,5681,5686,5692,5698,5704,5710,5716,5722,5728,5734,5740,5746,5752,5758,5763,5770,5776,5782,5788,5794,5801,5807,5813,5819,5825,5831,5837,5843,5849,5855,5860,5867,5873,5879,5885,5891,5897,5903,5909,5915,5921,5927,5933,5939,5945,5951,5957,5962,5968,5974,5980,5986,5992,5997,6003,6009,6015,6021,6027,6033,6039,6045,6051,6057,6063,6069,6075,6081,6087,6093,6099,6105,6111,6117,6123,6129,6138,6144,6150,6156,6162,6169,6175,6180,6186,6191,6197],{"id":3517,"class_notification":3518,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3520,"generic_name":3521,"generic_name_definition":3522,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3524,"old_generic_name":3525,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3526,"growth_ratio":3527,"average_price":3528,"domestic_ratio":3529,"product_count":3530,"company_count":3531,"market_size_unit":205,"average_price_unit":206,"created_at":207},568,"1-0570","生体内移植器具","35666000","人工股関節大腿骨コンポーネント","大腿骨骨頭の置換に用いる人工股関節コンポーネントをいう。大腿骨頸部の置換に用いるものもある。通常、近位端にトラニオン又は骨頭を備える。本品は、通常、金属、カーボン又はセラミック製で、多くのパーツからなる。また、身体への固定を補強するネジ等の器具を備えたものもある。非拘束式又は拘束式のものがある。セメント固定式のもの又はセメントレスのものがある。","8","140212028","人工股関節",778.8,11.33,22.58,22.7,290,29,{"id":3533,"class_notification":3534,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3535,"generic_name":3536,"generic_name_definition":3537,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3540,"growth_ratio":3541,"average_price":3542,"domestic_ratio":3543,"product_count":3544,"company_count":3545,"market_size_unit":205,"average_price_unit":206,"created_at":207},602,"1-0604","37272003","脊椎内固定器具","ロッド・プレート・フック・スクリュー(椎弓根スクリューを含む)・コネクタ・ワイヤ・ケーブル等からなる器具をいう。脊椎の固定、支持又はアライメント補正に用いる。通常、金属製、ポリマー製又は他の材料製である。骨折固定、変性又は先天性異常に用いる場合もある。","140212161","骨接合用品",647.1,26.29,4.02,9.4,363,47,{"id":3547,"class_notification":3548,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3549,"code":3550,"generic_name":3551,"generic_name_definition":3552,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3556,"growth_ratio":3557,"average_price":3558,"domestic_ratio":3559,"product_count":3560,"company_count":204,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4455,"3-1218","その他の家庭用医療機器","71105001","家庭用遠赤外線血行促進用衣","遠赤外線の血行促進作用により疲労や筋肉のこり等の症状改善を行うことを目的とした、衣類形状の器具をいう。生地に鉱物等による特殊な加工が施されており、一定程度の遠赤外線を輻射する。上半身用及び下半身用があり、それぞれ少なくとも上腕部および大腿部を被覆する。ただし、パーツ形状は含まないものとする。","Ⅰ","1","非該当",391.5,0,6245,6.1,41,"円/個",{"id":3563,"class_notification":3564,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3565,"generic_name":3566,"generic_name_definition":3567,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3568,"old_generic_name":3569,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3570,"growth_ratio":3571,"average_price":3572,"domestic_ratio":3573,"product_count":382,"company_count":3574,"market_size_unit":205,"average_price_unit":206,"created_at":207},572,"1-0574","35667000","全人工膝関節","損傷・変性を来した膝関節の全関節表面を置換する人工関節をいう。拘束式、半拘束式又は非拘束式のものがある。ヒンジ等で結合され、ともに関節を形成するように設計された複数のパーツからなるものもある。本品は、通常、金属、カーボン、セラミック又はポリマー製等で、パーツにはこのような材料のいずれか又はすべてを使用している。セメント固定式のもの又はセメントレスのものがある。","140212044","人工膝関節",384.7,1.78,13.66,8.5,18,{"id":3576,"class_notification":3577,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3578,"code":3579,"generic_name":3580,"generic_name_definition":3581,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3584,"old_generic_name":3580,"old_class_classification":3553,"old_repair_category":194,"revision_count":926,"last_updated_date":3585,"data_exist":198,"product_exist":198,"market_size":3586,"growth_ratio":3587,"average_price":3588,"domestic_ratio":3589,"product_count":3590,"company_count":3591,"market_size_unit":205,"average_price_unit":3592,"created_at":207},4429,"3-1192","家庭用衛生用品","34864000","救急絆創膏","身体の部位に用いる、粘着剤を付した布製、プラスチック製等の各種形状の絆創膏材をいう。パッドを付する場合もある。傷の被覆及び保護、傷口の皮膚接合、身体の創傷部位の支持等に用いる。","4","該当","281404005","平成28年10月19日",307.3,-46.76,5361,71.6,241,52,"円/千枚",{"id":3594,"class_notification":3595,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3596,"generic_name":3597,"generic_name_definition":3598,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3599,"growth_ratio":3600,"average_price":3601,"domestic_ratio":3602,"product_count":3603,"company_count":3604,"market_size_unit":205,"average_price_unit":206,"created_at":207},594,"1-0596","35241003","体内固定用プレート","骨奇形や骨折治療時に骨折間隙を埋め、骨折部位を応力から保護するため、骨折片にネジ等で取り付ける非吸収性植込み型固定器具をいう。病的に骨折した骨の骨延長術、及び頭蓋、顎顔面手術時の補強、又は固定術が必要な関節の融合に用いる場合もある。骨プレートは、通常、金属製、カーボン製等である。",286.8,9.28,1.46,46.1,483,59,{"id":3606,"class_notification":3607,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3608,"generic_name":3609,"generic_name_definition":3610,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3524,"old_generic_name":3525,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3611,"growth_ratio":3612,"average_price":3613,"domestic_ratio":3614,"product_count":3615,"company_count":3616,"market_size_unit":205,"average_price_unit":206,"created_at":207},567,"1-0569","35661000","人工股関節寛骨臼コンポーネント","寛骨臼の置換又は修復に用いる人工股関節コンポーネントをいう。一体構造のものもあれば、金属又はセラミック製等の外殻及び金属、ポリマー又はセラミック製等のインナーライナーからなるものもある。また、身体への固定を補強するネジ等の器具を備えたものもある。非拘束式又は拘束式のものがある。",252,10.42,8.45,12.7,139,23,{"id":3618,"class_notification":3619,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3620,"generic_name":3621,"generic_name_definition":3622,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3623,"growth_ratio":3624,"average_price":3625,"domestic_ratio":3626,"product_count":3627,"company_count":3628,"market_size_unit":205,"average_price_unit":206,"created_at":207},589,"1-0591","33187000","体内固定用大腿骨髄内釘","金属製等のロッドをいう。大腿骨の髄内に挿入し、骨折又は病的状態にある骨の両端を正しい位置に保持する固定器具としての役割を果たす。骨の欠損、病的短絡が認められる場合に骨を延長、矯正するために用いる場合もある。多くのコンポーネントを備え、さらに近位及び遠位の骨折の固定を補助するロック型式のものもあればロック型式でないものもある。",221.3,-6.13,5.01,33.8,81,27,{"id":3630,"class_notification":3631,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":3632,"generic_name":3633,"generic_name_definition":3634,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3635,"growth_ratio":3636,"average_price":3637,"domestic_ratio":3638,"product_count":3639,"company_count":3640,"market_size_unit":205,"average_price_unit":206,"created_at":207},1040,"1-1042","42348000","歯科用インプラントフィクスチャ","外科的に骨内に埋植する歯科用インプラントの一部をいう。",151.7,23.48,4.04,24.5,65,20,{"id":3642,"class_notification":3643,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3645,"generic_name":3646,"generic_name_definition":3647,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3648,"old_generic_name":3649,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3650,"growth_ratio":3651,"average_price":3652,"domestic_ratio":3653,"product_count":3654,"company_count":3639,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3797,"3-0560","外科・整形外科用手術材料","35531000","単回使用汎用サージカルドレープ","手術室やカテーテル処置室の汚染(器具やテーブルの上)から外科切開部位や術野を隔離するために、保護的なカバー又は障壁として用いる不織布製の用具をいう。本品は患者を手術中の熱、炎又は他の形態のエネルギーから保護するためにも使用する。本品は単回使用である。","101010001","滅菌済み手術用不織布製品",145.6,5.9,657,52.1,182,{"id":3656,"class_notification":3657,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3658,"generic_name":3659,"generic_name_definition":3660,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3661,"growth_ratio":3662,"average_price":3663,"domestic_ratio":3664,"product_count":3665,"company_count":3666,"market_size_unit":205,"average_price_unit":3561,"created_at":207},585,"1-0587","16101003","体内固定用ネジ","骨固定用の器具で、プレート又は釘を骨に取り付けるか、軟部組織、シート又は不織布を骨に固定するか、又は骨折片を安定化させる非吸収性のものをいう。本品は整形外科及び顎顔面手術等で使用する。皮質骨ネジ、海綿骨ネジ、踝骨ネジ、舟状骨ネジ、部分的にネジ山のあるもの、全体的にネジ山のあるもの等多くの種類がある。ラグネジは骨折片全体を圧縮させるために特別な方法で使用するものをいう。通常、金属製等である。",144.4,8.35,9188,28.2,169,42,{"id":23,"class_notification":3668,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3669,"generic_name":3670,"generic_name_definition":3671,"class_classification":192,"ghtf_rule":3672,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3676,"growth_ratio":3677,"average_price":3678,"domestic_ratio":3679,"product_count":3680,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-0183","34212000","癒着防止吸収性バリア","外科的に埋め込む生体吸収性の器具をいう。臓器や体内部位が他の体内部位に対して異常な線維性の癒着をしないよう予防するために用いる。","7-④","101099008","その他の外科・整形外科用手術材料","☆",141.4,-36.06,3.93,25.7,4,{"id":3682,"class_notification":3683,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3684,"generic_name":3685,"generic_name_definition":3686,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3687,"growth_ratio":3688,"average_price":3689,"domestic_ratio":3690,"product_count":3691,"company_count":3692,"market_size_unit":205,"average_price_unit":206,"created_at":207},606,"1-0608","38161003","脊椎ケージ","椎間板又は脊椎の一部の代わりに脊柱構造の高さを置換、矯正又は修復するために用いる器具をいう。通常、金属、ポリマー、吸収性材料、他の人工材料、生物学的材料、又はこのような物質の組合せを原材料とする。",140,9.84,12.68,14.3,179,35,{"id":3694,"class_notification":3695,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3696,"generic_name":3697,"generic_name_definition":3698,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3699,"old_generic_name":3697,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3700,"growth_ratio":3701,"average_price":3702,"domestic_ratio":3703,"product_count":3704,"company_count":3574,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3799,"3-0562","33056000","ギプス包帯","骨折、疾患のある関節又は疼痛のある捻挫を固定するために、固い被覆保護材（ギプス包帯）を構成するプラスティック、ガラス繊維、石膏等の用具をいう。","101012005",132.3,7.79,3760,58.9,60,{"id":743,"class_notification":3706,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3707,"generic_name":3708,"generic_name_definition":3709,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3524,"old_generic_name":3525,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3710,"growth_ratio":3711,"average_price":3712,"domestic_ratio":3713,"product_count":3714,"company_count":3715,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-0567","33704000","人工骨頭","大腿骨骨頭・頸部を置換する人工関節をいう。近位股関節骨折又は関節炎等の症例に使用する。一体型のものと、トラニオン付ステムと骨頭から構成されるものがある。骨頭(球)コンポーネント自体は、単体又は外殻やインナーライナー等からなる。金属、カーボン、ポリマー又はセラミック製等のものがある。セメント固定式のもの又はセメントレスのものがある。",129.1,11.54,8.49,17.4,62,28,{"id":3717,"class_notification":3718,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3719,"generic_name":3720,"generic_name_definition":3721,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3722,"old_generic_name":3720,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3723,"growth_ratio":3724,"average_price":3725,"domestic_ratio":3726,"product_count":3727,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},175,"1-0175","35895100","吸収性局所止血材","止血のために、外科切開口、皮膚創傷又は内部構造に適用する、身体に吸収される素材からなる器具をいう。","101006000",113.8,8.25,4.81,30.1,7,{"id":3729,"class_notification":3730,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3731,"generic_name":3732,"generic_name_definition":3733,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3568,"old_generic_name":3569,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3734,"growth_ratio":3735,"average_price":3736,"domestic_ratio":3737,"product_count":3738,"company_count":3739,"market_size_unit":205,"average_price_unit":206,"created_at":207},574,"1-0576","35669000","人工膝関節脛骨コンポーネント","膝関節の脛骨プラトーの修復又は置換に用いる人工関節コンポーネントをいう。人工大腿骨コンポーネントと関節をなすように設計されている。通常、金属、セラミック又はポリマー製で骨セメントを用いて固定するものもある。ステム、固定ネジ及びポリマー差込部を備えた金属トレイを含むものもある。",93.85,-10,9.62,8.3,78,16,{"id":3741,"class_notification":3742,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3578,"code":3743,"generic_name":3744,"generic_name_definition":3745,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3748,"old_generic_name":3749,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3750,"growth_ratio":3751,"average_price":3752,"domestic_ratio":3753,"product_count":3754,"company_count":3755,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2981,"2-1780","71025000","家庭用創傷パッド","ハイドロコロイド等の材質からなる家庭で創傷を被覆するパッドをいう。軽度の切り傷、擦り傷、刺し傷、かき傷、靴ずれ等の創傷や軽度の熱傷を保護する。湿潤環境を維持し、痛みの軽減や治癒の促進を図る。","Ⅱ","4-②","281499007","その他の家庭用衛生用品",86.51,-9.66,300,10.1,24,13,{"id":3757,"class_notification":3758,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3759,"generic_name":3760,"generic_name_definition":3761,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3524,"old_generic_name":3525,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3762,"growth_ratio":3763,"average_price":3764,"domestic_ratio":3765,"product_count":3766,"company_count":3616,"market_size_unit":205,"average_price_unit":206,"created_at":207},569,"1-0571","36315000","全人工股関節","股関節の関節部を置換するために用いる人工関節をいう。通常大腿骨及び寛骨臼に適合するコンポーネントからなる。人工股関節のデザインに応じて、ネジ及びボルト、ブロックなどの器具を備えたものもある。通常、金属、ポリマー及びセラミックを原材料とする。植え込み時にセメントを使用する場合もあれば使用しない場合もある。",77.06,7.36,5.53,11,91,{"id":978,"class_notification":3768,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3769,"generic_name":3770,"generic_name_definition":3771,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3772,"growth_ratio":3773,"average_price":3774,"domestic_ratio":3775,"product_count":3776,"company_count":3777,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-0602","36174003","靭帯固定具","靭帯、腱又は人工靭帯の片端又は両端を骨に結合するために用いる非吸収性植込み型器具をいう。通常、金属製、セラミック製等である。",74.55,23.63,4.11,0.1,116,14,{"id":3779,"class_notification":3780,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":3782,"generic_name":3783,"generic_name_definition":3784,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3787,"growth_ratio":3788,"average_price":3789,"domestic_ratio":3790,"product_count":3791,"company_count":3792,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4408,"3-1171","衛生材料","13700000","医療ガーゼ","出血の抑制、液の吸収、擦過傷、乾燥又は汚染からの器官の保護のため、外科切開口、他の皮膚創傷又は内部構造に適用することを目的とする主としてガーゼから成る器具をいう。","260202006","医用不織布ガーゼ",70.1,8.89,108,13.9,237,55,{"id":3794,"class_notification":3795,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":3796,"generic_name":3797,"generic_name_definition":3798,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3799,"growth_ratio":3800,"average_price":3801,"domestic_ratio":3802,"product_count":3590,"company_count":3803,"market_size_unit":205,"average_price_unit":206,"created_at":207},1047,"1-1049","70910000","歯科用インプラントアバットメント","歯科用インプラントフィクスチャに固定して上部構造体の支台となるもの又は歯肉が治癒するまで暫間的に使用するものをいう。",66.42,10.26,1.03,22.5,32,{"id":3805,"class_notification":3806,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3807,"generic_name":3808,"generic_name_definition":3809,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3568,"old_generic_name":3569,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3810,"growth_ratio":3811,"average_price":3812,"domestic_ratio":3813,"product_count":3628,"company_count":3765,"market_size_unit":205,"average_price_unit":206,"created_at":207},570,"1-0572","32833000","片側型人工膝関節","片側の大腿顆及びこれに対応する脛骨顆の支持面を置換する人工関節をいう。",63.94,-0.28,9.88,5.4,{"id":3815,"class_notification":3816,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3817,"generic_name":3818,"generic_name_definition":3819,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3820,"old_generic_name":3821,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":3822,"data_exist":198,"product_exist":198,"market_size":3823,"growth_ratio":3824,"average_price":3825,"domestic_ratio":276,"product_count":610,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},647,"1-0649","35643000","人工内耳","高音急墜型感音難聴又は重度聴覚障害者の聴覚の一部回復のために用いる機器をいう。電極アレー（片側の蝸牛に挿入する）、受信・刺激装置（頭蓋の耳付近に植え込む）、スピーチプロセッサ（体外に装着し、音を電気信号に変換して受信・刺激装置に送るもの）から構成される。音響刺激機能のある機器は、音響ユニット（音を増幅・音質調整してイヤモールドへ伝達する）が含まれる。","140214993","その他の感覚機能補助器","平成26年2月21日",58.71,8.43,34.2,{"id":3827,"class_notification":3828,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3829,"generic_name":3830,"generic_name_definition":3831,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3835,"growth_ratio":3836,"average_price":3837,"domestic_ratio":286,"product_count":3616,"company_count":3838,"market_size_unit":205,"average_price_unit":206,"created_at":207},517,"1-0519","70433013","非吸収性ヘルニア・胸壁・腹壁用補綴材","脆弱化もくは欠損した胸壁、腹壁又はヘルニアの修復に用いる非吸収性合成繊維製の器具をいう。","101004006","組織代用合成繊維布","Ⅱ/Ⅲ/Ⅳ",55.86,3.53,3.74,12,{"id":764,"class_notification":3840,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":3841,"generic_name":3842,"generic_name_definition":3843,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":926,"last_updated_date":3844,"data_exist":198,"product_exist":198,"market_size":3845,"growth_ratio":3846,"average_price":3847,"domestic_ratio":3848,"product_count":3849,"company_count":3850,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-1048","70909000","歯科用インプラントシステム","歯科用インプラント、歯科用インプラントアバットメント、インプラント埋植手術用器材及び上部構造の作製に用いる技工用器具から成るシステムをいう。","平成29年10月26日",50.89,7.84,1.45,11.8,102,31,{"id":3852,"class_notification":3853,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3854,"generic_name":3855,"generic_name_definition":3856,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3857,"growth_ratio":3858,"average_price":3859,"domestic_ratio":3860,"product_count":3861,"company_count":3862,"market_size_unit":205,"average_price_unit":206,"created_at":207},588,"1-0590","32854003","体内固定用ピン","内外固定や牽引装置を支持したり、又は骨及び軟部組織や靭帯を骨に固定するため等に用いる非吸収性器具をいう。",46.15,-6.25,1.08,81.9,77,37,{"id":3864,"class_notification":3865,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3866,"generic_name":3867,"generic_name_definition":3868,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3869,"old_generic_name":3870,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3871,"growth_ratio":3872,"average_price":3873,"domestic_ratio":3557,"product_count":3754,"company_count":3874,"market_size_unit":205,"average_price_unit":206,"created_at":207},612,"1-0614","35217000","整形外科用骨セメント","通常、メチルメタクリレート、ポリメチルメタクリレート(PMMA)、メタクリル酸エステル又はポリメチルメタクリレート及びポリスチレンを含むコポリマーを原料とする物質をいう。関節形成術でポリマー、金属又はセラミック製等の人工関節を生体骨に固定するために用いる。骨病巣損傷部位の充填剤として用いる場合もある。抗生物質を含有するものがある。","140212187","骨セメント",45.93,9.74,1.93,10,{"id":3876,"class_notification":3877,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3878,"generic_name":3879,"generic_name_definition":3880,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":3883,"data_exist":198,"product_exist":198,"market_size":3884,"growth_ratio":3885,"average_price":3886,"domestic_ratio":3557,"product_count":3727,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},682,"1-0684","36099000","眼内ドレーン","眼内に植え込み、眼圧上昇を緩和するために用いる人工ドレーンをいう。","140299005","その他の生体内移植器具","平成28年3月25日",41.81,54.97,13.94,{"id":955,"class_notification":3888,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3889,"generic_name":3890,"generic_name_definition":3891,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3892,"growth_ratio":3893,"average_price":3894,"domestic_ratio":3895,"product_count":3692,"company_count":3727,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-0240","36174004","吸収性靭帯固定具","靭帯、腱又は人工靭帯の片端又は両端を骨に結合するために用いる吸収性植込み型器具をいう。",41.56,11.56,5.32,1.4,{"id":3897,"class_notification":3898,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3899,"generic_name":3900,"generic_name_definition":3901,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3902,"growth_ratio":3903,"average_price":3904,"domestic_ratio":3905,"product_count":3755,"company_count":3727,"market_size_unit":205,"average_price_unit":206,"created_at":207},603,"1-0605","38152000","体内固定用脛骨髄内釘","金属製等のロッドをいう。脛骨の髄内に挿入し、骨折又は病的状態にある骨の両端を正しい位置に保持するための固定器具としての役割を果たす。骨の欠損、病的短絡が認められる場合に骨を延長、矯正するために用いる場合もある。多くのコンポーネントを備え、さらに近位及び遠位の骨折の固定を補助するロック型式のものもあればロック型式でないものもある。",39.54,14.02,2.39,0.2,{"id":3907,"class_notification":3908,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":3909,"generic_name":3910,"generic_name_definition":3911,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3912,"growth_ratio":3913,"average_price":3914,"domestic_ratio":3690,"product_count":3915,"company_count":3916,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4413,"3-1176","34655000","医療用不織布","創傷又は外科切開部を処置するために用いる不織布から成る被覆・保護材をいう。",38.24,-0.54,15,203,58,{"id":3918,"class_notification":3919,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3920,"generic_name":3921,"generic_name_definition":3922,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3923,"growth_ratio":3924,"average_price":3925,"domestic_ratio":3926,"product_count":3754,"company_count":203,"market_size_unit":205,"average_price_unit":206,"created_at":207},515,"1-0517","35717003","非吸収性人工靭帯","欠損又は損傷した靭帯構造の機能回復のために置換又は修復を目的とした植込み型器具をいう。本品は非吸収性材料製である。",36.52,5.81,6.2,28.5,{"id":3928,"class_notification":3929,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3930,"generic_name":3931,"generic_name_definition":3932,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3933,"growth_ratio":3934,"average_price":3935,"domestic_ratio":202,"product_count":3755,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},229,"1-0229","16101004","吸収性体内固定用ネジ","骨固定用の器具で、プレート又は釘を骨に取り付けるか、軟部組織を骨に固定するか、又は骨片を安定化させる吸収性のものをいう。本品は整形外科及び顎顔面手術等で使用する。皮質骨ネジ、海綿骨ネジ、踝骨ネジ、舟状骨ネジ、部分的にネジ山のあるもの、全体的にネジ山のあるもの等多くの種類がある。ラグネジは骨折片全体を圧縮させるために特別な方法で使用するものをいう。",36.11,12.37,3.4,{"id":3937,"class_notification":3938,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":3939,"generic_name":3940,"generic_name_definition":3941,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3942,"growth_ratio":3943,"average_price":3944,"domestic_ratio":3945,"product_count":3946,"company_count":3628,"market_size_unit":205,"average_price_unit":206,"created_at":207},1039,"1-1041","42347000","歯科用骨内インプラント材","部分的又は全体的に顎骨内に埋植する歯科用インプラントをいう。",35.28,9.33,1.61,36.6,68,{"id":482,"class_notification":3948,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3949,"generic_name":3950,"generic_name_definition":3951,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3952,"old_generic_name":3953,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3954,"growth_ratio":3955,"average_price":3956,"domestic_ratio":3957,"product_count":3850,"company_count":3874,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-0579","35670000","全人工肩関節","肩の関節面の置換又は修復のために用いる人工関節をいう。通常、金属、セラミック、カーボン又はポリマー又はこのような物質の組合せを原材料とする。非拘束式、拘束式又は半拘束式のものがある。セメント固定式のもの又はセメントレスのものがある。","140212060","人工肩関節",34.12,-0.25,5.6,27.9,{"id":3959,"class_notification":3960,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3961,"generic_name":3962,"generic_name_definition":3963,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3965,"growth_ratio":3966,"average_price":3967,"domestic_ratio":3895,"product_count":3765,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},266,"1-0266","36182000","人工心膜用補綴材","心膜欠損部の補填のために、シート材料(心臓及び大血管根部を包む円錐形の二重膜線維漿膜性サック)や塞栓形成インプラントを心膜欠損部に導入する組み合わせ機器をいう。シート材料や塞栓形成インプラントは生物学的材料又は人工材料製である。シート材料や塞栓形成インプラント、挿入器などからなり、手術に必要な他の用品が含まれるキットの場合もある。","8-②",33.83,14.58,23.37,{"id":3969,"class_notification":3970,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3971,"generic_name":3972,"generic_name_definition":3973,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3568,"old_generic_name":3569,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3974,"growth_ratio":3975,"average_price":3976,"domestic_ratio":3977,"product_count":3978,"company_count":3765,"market_size_unit":205,"average_price_unit":206,"created_at":207},573,"1-0575","35668000","人工膝関節大腿骨コンポーネント","膝の大腿骨関節の修復又は置換に用いる人工関節コンポーネントをいう。脛骨コンポーネントと関節をなし、必要に応じて膝関節の人工膝蓋骨コンポーネントと関節をなすように設計されている。通常、金属、セラミック又はポリマー製で骨セメントを用いて固定するものもある。ステム及び固定機構を備えたものもある。",31.73,23.96,21.82,3.6,38,{"id":3980,"class_notification":3981,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":3982,"generic_name":3983,"generic_name_definition":3984,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3985,"old_generic_name":3986,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3987,"growth_ratio":3988,"average_price":3989,"domestic_ratio":3990,"product_count":3991,"company_count":3574,"market_size_unit":205,"average_price_unit":206,"created_at":207},583,"1-0585","17751000","人工骨インプラント","外傷、骨粗鬆症等の病的状態により欠損した骨を置換するために体内に挿入又は移植する骨基質の合成材料製器具をいう。粉体、液状及びペースト状等のものを含む。","140212129","合成樹脂製人工骨",29.76,1.63,2.43,95.8,82,{"id":3993,"class_notification":3994,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":3995,"generic_name":3996,"generic_name_definition":3997,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3722,"old_generic_name":3720,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3999,"growth_ratio":4000,"average_price":4001,"domestic_ratio":4002,"product_count":3727,"company_count":276,"market_size_unit":205,"average_price_unit":3561,"created_at":207},176,"1-0176","35895200","コラーゲン使用吸収性局所止血材","止血のために、外科切開口、皮膚創傷又は内部構造に適用する、身体に吸収される素材からなるコラーゲン使用器具をいう。","8-⑤,14",29.16,28.62,5115,88.8,{"id":4004,"class_notification":4005,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4006,"generic_name":4007,"generic_name_definition":4008,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4009,"growth_ratio":4010,"average_price":4011,"domestic_ratio":4012,"product_count":4013,"company_count":3739,"market_size_unit":205,"average_price_unit":206,"created_at":207},609,"1-0611","70504000","体内固定用ケーブル","骨固定に用いる非吸収性ケーブル（撚り線構造又は編み線構造）をいう。体内固定器具として使用する。肘頭、膝蓋骨、足関節内果又は大転子等の骨折又は骨切り部を再結合したり、脊椎を固定したりするために、原則として締結噐を用いて締結するものである。ケーブルと併用するインプラント等も含む。素材は、通常、金属製又はポリマー製である。",28.97,-10.14,2.72,80.1,40,{"id":4015,"class_notification":4016,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4017,"generic_name":4018,"generic_name_definition":4019,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":926,"last_updated_date":4020,"data_exist":198,"product_exist":198,"market_size":4021,"growth_ratio":4022,"average_price":4023,"domestic_ratio":4024,"product_count":4025,"company_count":3914,"market_size_unit":205,"average_price_unit":206,"created_at":207},604,"1-0606","38153000","体内固定用上肢髄内釘","金属製等のロッドをいう。上腕骨、前腕骨、鎖骨等の上肢骨の髄内に挿入し、骨折した又は病的状態にある骨の両端を正しい位置に保持する固定器具としての役割を果たす。骨の欠損、病的短絡が認められる場合に骨を延長、矯正するために用いる場合もある。さらに近位及び遠位の骨折の固定を補助するために多くのコンポーネントを有するロック型式のものもあればロック型式でないものもある。","平成30年6月4日",27.49,2.32,3.63,6.4,36,{"id":4027,"class_notification":4028,"specific_maintenance_notification":4029,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":4031,"generic_name":4032,"generic_name_definition":4033,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":3583,"installation_management":185,"repair_category":4035,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":4037,"growth_ratio":3557,"average_price":4038,"domestic_ratio":3557,"product_count":203,"company_count":286,"market_size_unit":205,"average_price_unit":3561,"created_at":207},1072,"1-1074","1186","その他の処置用機器","20395000","陰圧創傷治療システム","管理された陰圧を付加し、創の保護、肉芽形成の促進、滲出液と感染性老廃物の除去を図り、創傷治癒を促進させるシステムをいう。通常、陰圧維持監視装置、フォーム、フィルムドレープ、連結チューブ及び浸出液貯蔵容器から構成される。","4-①","G3",false,25.28,6427,{"id":4040,"class_notification":4041,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4042,"generic_name":4043,"generic_name_definition":4044,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4045,"growth_ratio":4046,"average_price":4047,"domestic_ratio":4048,"product_count":3803,"company_count":4049,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3819,"3-0582","70444000","カテーテル被覆・保護材","注射針又はカテーテル刺入部位に直接貼付してその固定に用いる、粘着性を有するフィルム材などの滅菌済み被覆・保護材をいう。固定保持強化のために不織布等が付与されることもある。",24.33,2.71,76,25.9,19,{"id":4051,"class_notification":4052,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4053,"generic_name":4054,"generic_name_definition":4055,"class_classification":192,"ghtf_rule":3672,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4056,"growth_ratio":4057,"average_price":4058,"domestic_ratio":3557,"product_count":3739,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},173,"1-0173","70433004","吸収性ヘルニア・胸壁・腹壁用補綴材","脆弱化や欠損した胸壁、腹壁又はヘルニアの修復に用いる吸収性の器具をいう。非吸収性材料が含まれる場合もある。",23.41,-6.1,5.51,{"id":4060,"class_notification":4061,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4062,"generic_name":4063,"generic_name_definition":4064,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3952,"old_generic_name":3953,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4065,"growth_ratio":4066,"average_price":4067,"domestic_ratio":3557,"product_count":3803,"company_count":203,"market_size_unit":205,"average_price_unit":206,"created_at":207},576,"1-0578","32835000","人工肩関節上腕骨コンポーネント","人工肩関節のコンポーネントをいう。関節面の置換又は修復のために近位上腕骨に取り付ける。通常、金属、セラミック、カーボン又はポリマー又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",22.22,5.27,15.18,{"id":4069,"class_notification":4070,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4071,"generic_name":4072,"generic_name_definition":4073,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4074,"growth_ratio":4075,"average_price":4076,"domestic_ratio":4077,"product_count":204,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},235,"1-0235","35241004","吸収性体内固定用プレート","骨奇形や骨折治療時に骨折間隙を埋め、骨折部位を応力から保護するため、骨折片にネジで取り付ける吸収性植込み型固定器具をいう。病的に骨折した骨の骨延長術、及び頭蓋、顎顔面手術時の補強、又は固定術が必要な関節の融合に用いる場合もある。",20.46,4.58,3.99,74.6,{"id":4079,"class_notification":4080,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4081,"code":4082,"generic_name":4083,"generic_name_definition":4084,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":3555,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":4085,"old_generic_name":4086,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4087,"growth_ratio":4088,"average_price":4089,"domestic_ratio":4090,"product_count":4025,"company_count":3680,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4427,"3-1190","家庭用磁気・熱療法治療器","71019000","家庭用温熱パック","発熱する特殊な化学物質等を内蔵したもので、活性化することにより発熱したものを患部に当て、消炎鎮痛処置（温熱治療）を行う単回使用のパックをいう。本品は家庭において使用される。","280604996","その他の家庭用熱療法治療器",19.35,20.94,83,99.9,{"id":4092,"class_notification":4093,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4094,"generic_name":4095,"generic_name_definition":4096,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4100,"growth_ratio":4101,"average_price":4102,"domestic_ratio":4103,"product_count":3666,"company_count":3616,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2819,"2-1618","38609000","歯科根管用ポスト成形品","維持又は補強手段として、形成後の根管に挿入する既製のポスト又はロッドをいう。既製ポストは様々な形状、寸法があり、材料も合金、セラミックス、繊維強化型プラスチック製等がある。","8-①","209999004","他に分類されない歯科材料",19.34,-8.36,448,24.1,{"id":4105,"class_notification":4106,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4107,"generic_name":4108,"generic_name_definition":4109,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4112,"growth_ratio":4113,"average_price":4114,"domestic_ratio":4115,"product_count":4116,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},638,"1-0640","70508000","下肢再建用人工材料","悪性腫瘍等の疾患により広範囲な骨切除を行ったとき、骨欠損部を補綴したり下肢機能を再建するために用いるインプラントをいう。人工関節及びその連結部品、付属品を含む。","140212998","その他の人工関節人工骨及び関連製品",18.51,-17.45,36.48,31.6,26,{"id":4118,"class_notification":4119,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4120,"generic_name":4121,"generic_name_definition":4122,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":4123,"growth_ratio":3557,"average_price":4124,"domestic_ratio":4125,"product_count":286,"company_count":3727,"market_size_unit":205,"average_price_unit":206,"created_at":207},1133,"1-1135","60424004","放射線治療用吸収性組織スペーサ","臓器、組織等の間に外科的又は経皮的に留置して、悪性腫瘍と正常組織との間に距離を空けることで、放射線治療における正常組織の放射線被曝を低減するために用いる吸収性の材料をいう。",16.08,18.26,1.2,{"id":4127,"class_notification":4128,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4129,"generic_name":4130,"generic_name_definition":4131,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4132,"growth_ratio":4133,"average_price":3874,"domestic_ratio":4134,"product_count":4135,"company_count":4136,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4414,"3-1177","70975000","医療脱脂綿","医薬品を塗布したり、患者の体表から少量の体液を吸収したりする等、医療目的に使用するパッド状の綿繊維から成る材料をいう。",15.58,15.51,66.9,124,43,{"id":4138,"class_notification":4139,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4140,"generic_name":4141,"generic_name_definition":4142,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":926,"last_updated_date":3585,"data_exist":198,"product_exist":198,"market_size":4143,"growth_ratio":4144,"average_price":4145,"domestic_ratio":4115,"product_count":3789,"company_count":2500,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4411,"3-1174","32374000","X線造影材入りガーゼ","出血の抑制、液の吸収、又は擦過傷、乾燥若しくは汚染からの器官の保護を目的として、身体内部又は外科切開部に用いる綿又はセルロース製の薬品を含まない吸収材料をいう。X線で検知できる成分を含む。",14.57,-8.96,990,{"id":4147,"class_notification":4148,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4149,"generic_name":4150,"generic_name_definition":4151,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4152,"growth_ratio":4153,"average_price":4154,"domestic_ratio":4155,"product_count":3640,"company_count":3838,"market_size_unit":205,"average_price_unit":206,"created_at":207},688,"1-0690","40808000","植込み型病変識別マーカ","フィルム又はデジタル画像上で確認することができる識別マークを作成するために体内に一時的又は永久的に植え込むことを目的としたワイヤ、針、クリップ又はビーズ状の器具をいう。腫瘍、病変などの関心領域の位置決定及び描出に用いる。磁気共鳴画像診断法(MRI)、X線又は核医学など、使用する撮像システムと互換性のある材料から作られる。",13.19,8.52,4.68,13.3,{"id":4157,"class_notification":4158,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4159,"generic_name":4160,"generic_name_definition":4161,"class_classification":192,"ghtf_rule":4162,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4163,"growth_ratio":4164,"average_price":3944,"domestic_ratio":4165,"product_count":3978,"company_count":3914,"market_size_unit":205,"average_price_unit":206,"created_at":207},186,"1-0186","70437204","吸収性骨再生用材料","骨組織の再生を図る目的で、被覆、塗布、充填等によって患部に適用される吸収性材料をいう。生物学的効果を意図したり、医薬品を含有したり、生物由来原材料を使用したりすることがある。","8-⑤,13,14",12.94,-15.24,98.3,{"id":4167,"class_notification":4168,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4169,"generic_name":4170,"generic_name_definition":4171,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4172,"growth_ratio":4173,"average_price":4174,"domestic_ratio":4175,"product_count":4176,"company_count":4177,"market_size_unit":205,"average_price_unit":206,"created_at":207},590,"1-0592","34003000","体内固定用コンプレッションヒッププレート","大腿骨近位で骨折した大腿骨頭を固定するために用いる器具をいう。通常、プレートからなり、このプレート近位のガイドホールに挿入する部分的にネジ山をもつ大きなネジとともに用いる。皮質骨ネジにより大腿骨に固定する。",12.61,12.53,3.8,49.3,39,17,{"id":4179,"class_notification":4180,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":4181,"generic_name":4182,"generic_name_definition":4183,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4184,"growth_ratio":4185,"average_price":4186,"domestic_ratio":3557,"product_count":4187,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},1094,"1-1096","58202003","単回使用陰圧創傷治療システム","管理された陰圧を付加し、創の保護、肉芽形成の促進、滲出液と感染性老廃物の除去を図り、創傷治癒を促進させるシステムをいう。通常、陰圧維持監視装置、フォーム、フィルムドレープ、連結チューブ及び滲出液貯蔵容器から構成される。本品は単回使用である。",11.87,-0.42,2.83,8,{"id":4189,"class_notification":4190,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4191,"generic_name":4192,"generic_name_definition":4193,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4194,"growth_ratio":4195,"average_price":4196,"domestic_ratio":4197,"product_count":4198,"company_count":3715,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4409,"3-1172","13705000","X線造影材入りスポンジ","出血の抑制、液の吸収、擦過傷、乾燥又は汚染からの器官の保護のため、外科切開口、他の皮膚創傷又は内部構造に適用することを目的とする、X線で検知可能な成分を含有する器具をいう。",11.74,-2.3,1469,51.4,128,{"id":4200,"class_notification":4201,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4202,"generic_name":4203,"generic_name_definition":4204,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4205,"data_exist":198,"product_exist":198,"market_size":4206,"growth_ratio":4207,"average_price":4208,"domestic_ratio":202,"product_count":204,"company_count":286,"market_size_unit":205,"average_price_unit":206,"created_at":207},271,"1-0271","70511000","合成人工硬膜","開放性頭部外傷や外傷性髄液瘻に続発して硬膜の欠損が生じた場合、あるいは開頭手術で硬膜の一部を切除する必要の生じた場合の硬膜補填もしくは硬膜代用する人工膜をいう。吸収性と非吸収性とがある。非吸収性膜は脳表面と硬膜との癒着防止を目的としても使用されることもある。","平成31年2月6日",10.93,-12.41,10.52,{"id":4210,"class_notification":4211,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4212,"generic_name":4213,"generic_name_definition":4214,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4215,"growth_ratio":4216,"average_price":4217,"domestic_ratio":3531,"product_count":4187,"company_count":3727,"market_size_unit":205,"average_price_unit":206,"created_at":207},174,"1-0174","70434000","吸収性組織補強材","臓器・組織の欠損部、脆弱部、縫合部を補強するために用いる吸収性の材料をいう。自動縫合器と併用される場合もある。ポリグリコール酸、グリコール酸-乳酸ポリエステル等の生分解性物質からなる。",10.88,-88.02,8.34,{"id":4219,"class_notification":4220,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4221,"generic_name":4222,"generic_name_definition":4223,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4224,"data_exist":198,"product_exist":198,"market_size":4225,"growth_ratio":4226,"average_price":4227,"domestic_ratio":4228,"product_count":3628,"company_count":3838,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3813,"3-0576","11751000","綿状創傷被覆・保護材","皮膚又は口腔内粘膜の創傷を被覆するために用いる、コットン、合成繊維、親水性ポリマー等からなるパッドをいう。ただし、口腔内粘膜に使用する場合は、一時的又は短期的に使用するものに限る。","平成30年8月8日",10.39,6.98,85,98.4,{"id":4230,"class_notification":4231,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4232,"generic_name":4233,"generic_name_definition":4234,"class_classification":197,"ghtf_rule":4235,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4236,"old_generic_name":4237,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4238,"growth_ratio":4239,"average_price":4240,"domestic_ratio":4241,"product_count":3754,"company_count":204,"market_size_unit":205,"average_price_unit":3561,"created_at":207},503,"1-0505","34614000","抗菌性創傷被覆・保護材","創傷の被覆に用いるため、殺菌剤・抗菌剤を含浸した滅菌済みの織布又は細片をいう。","4-①,13","101002103","抗菌性材料",10.11,6.86,519,3.9,{"id":4243,"class_notification":4244,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4245,"generic_name":4246,"generic_name_definition":4247,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4248,"growth_ratio":4249,"average_price":4250,"domestic_ratio":4251,"product_count":4252,"company_count":4253,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4406,"3-1169","11028000","コットンボール","様々な身体部位に薬物を塗布したり、又は液を除去するために用いる綿繊維の球状の塊をいう。",10.09,49.23,33,6.3,110,30,{"id":4255,"class_notification":4256,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":4257,"generic_name":4258,"generic_name_definition":4259,"class_classification":3746,"ghtf_rule":4260,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4263,"data_exist":198,"product_exist":198,"market_size":4264,"growth_ratio":4265,"average_price":4266,"domestic_ratio":202,"product_count":3680,"company_count":286,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2263,"2-1060","32142000","透析開始・終了セット","患者に透析を実施するために、透析の開始及び終了処置に必要な器具（単回使用のもの）及び材料（ガーゼ、圧迫綿、ピンセット等）を予め包装したセットをいう。","2-①","109999003","他に分類されない処置用機器","平成23年9月30日",9.77,-32.07,92,{"id":22,"class_notification":4268,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4269,"generic_name":4270,"generic_name_definition":4271,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4272,"growth_ratio":3557,"average_price":4273,"domestic_ratio":202,"product_count":276,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},"1-0247","17756000","コラーゲン使用人工骨","外傷、骨粗鬆症又は病的状態により欠損した骨を置換するために体内に挿入又は移植するコラーゲン使用材料をいう。",9.57,2.13,{"id":4275,"class_notification":4276,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4277,"generic_name":4278,"generic_name_definition":4279,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4282,"growth_ratio":4283,"average_price":3603,"domestic_ratio":4284,"product_count":3792,"company_count":2176,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3794,"3-0557","34654000","手術用被覆・保護材","術後創傷のために用いる適切なサイズの被覆・保護材をいう。","101002998","その他の創傷被覆・保護材",9.43,17.46,55.2,{"id":4286,"class_notification":4287,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4288,"generic_name":4289,"generic_name_definition":4290,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4291,"growth_ratio":4292,"average_price":4293,"domestic_ratio":3557,"product_count":4049,"company_count":4187,"market_size_unit":205,"average_price_unit":3561,"created_at":207},508,"1-0510","11323003","二次治癒フォーム状創傷被覆・保護材","滲出液が多量な創傷を被覆するために用いる、親水性フォーム製の二次治癒用の高吸収性パッドからなる創傷被覆・保護材をいう。",9.31,14.55,475,{"id":4295,"class_notification":4296,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4297,"generic_name":4298,"generic_name_definition":4299,"class_classification":197,"ghtf_rule":4300,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4301,"growth_ratio":4302,"average_price":4303,"domestic_ratio":4304,"product_count":4187,"company_count":3727,"market_size_unit":205,"average_price_unit":206,"created_at":207},530,"1-0532","70437103","非吸収性骨再生用材料","骨組織の再生を図る目的で、被覆、塗布、充填等によって患部に適用される非吸収性材料をいう。吸収性又は生物学的効果を意図するものを除く。医薬品を含有したり、生物由来原材料を使用したりすることがある。","8,13,14",9.07,-7.28,1.81,6.6,{"id":4306,"class_notification":4307,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4308,"generic_name":4309,"generic_name_definition":4310,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3573,"growth_ratio":4311,"average_price":4312,"domestic_ratio":3614,"product_count":4313,"company_count":4177,"market_size_unit":205,"average_price_unit":3561,"created_at":207},1090,"1-1092","46536003","歯科矯正用アンカースクリュー","歯科矯正治療において矯正力付与の固定源として使用する金属製の小さなねじである。口腔内の顎骨に植立・固定し、スクリューの頭部に矯正用器具を接続し、歯の移動のための矯正力を付与するときの固定源として用いる。セルフタップ型とセルフドリリング型があり、歯科矯正治療後は撤去される。単回使用である。",-22.74,6570,21,{"id":4315,"class_notification":4316,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4317,"generic_name":4318,"generic_name_definition":4319,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4320,"growth_ratio":4321,"average_price":3545,"domestic_ratio":3905,"product_count":3874,"company_count":203,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3818,"3-0581","70438000","皮膚接合用テープ","皮膚創部の閉鎖、接合又は補強等に用いる、片面を粘着剤でコーティングした布又はプラスチック製のテープをいう。",8.27,1.68,{"id":4323,"class_notification":4324,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4325,"generic_name":4326,"generic_name_definition":4327,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3722,"old_generic_name":3720,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4328,"growth_ratio":4329,"average_price":4330,"domestic_ratio":4331,"product_count":3755,"company_count":4187,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3795,"3-0558","33492101","皮膚用接着剤","皮膚創部の閉鎖、接合又は補強等に用いる皮膚用接着剤をいう。アクリル酸塩又は他の合成物質より成る。",8.14,35.54,6411,13.4,{"id":4333,"class_notification":4334,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4335,"generic_name":4336,"generic_name_definition":4337,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3952,"old_generic_name":3953,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4338,"growth_ratio":4339,"average_price":4340,"domestic_ratio":3557,"product_count":3574,"company_count":203,"market_size_unit":205,"average_price_unit":206,"created_at":207},578,"1-0580","36259000","人工肩関節関節窩コンポーネント","人工肩関節のコンポーネントをいう。関節面の置換又は修復のために関節窩に取り付ける。通常、金属、セラミック、カーボン又はポリマー又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",7.81,26.88,6.52,{"id":4342,"class_notification":4343,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4344,"generic_name":4345,"generic_name_definition":4346,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4347,"old_generic_name":4348,"old_class_classification":3746,"old_repair_category":194,"revision_count":926,"last_updated_date":4349,"data_exist":198,"product_exist":198,"market_size":4350,"growth_ratio":4351,"average_price":4352,"domestic_ratio":286,"product_count":3727,"company_count":4187,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2246,"2-1043","11325000","非固着性創傷被覆・保護材","固着することなく創傷を保護できるようにシリコーン又は白色ワセリンのエマルジョン等をコーティング又は含浸させたガーゼ状若しくはパッド状の被覆材をいう。","101002044","非固着性ガーゼ","平成23年3月31日",7.52,56.32,164,{"id":4354,"class_notification":4355,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4356,"generic_name":4357,"generic_name_definition":4358,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3568,"old_generic_name":3569,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4359,"growth_ratio":4360,"average_price":200,"domestic_ratio":4125,"product_count":3727,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},575,"1-0577","35679000","人工膝関節膝蓋骨コンポーネント","膝蓋骨の置換に用いる人工関節コンポーネントをいう。人工大腿骨コンポーネント遠位と関節をなすように設計され、骨セメントとともに用いるものもある。通常、金属、セラミック、ポリマー又はカーボン製等である。",7.41,-6.83,{"id":941,"class_notification":4362,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4363,"generic_name":4364,"generic_name_definition":4365,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4366,"old_generic_name":4367,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3727,"growth_ratio":4368,"average_price":4369,"domestic_ratio":4370,"product_count":3765,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},"1-0502","34082003","二次治癒ハイドロゲル創傷被覆・保護材","滲出液の吸収、出血又は体液損失の抑制、及び擦過、摩擦、乾燥、汚染からの創傷の保護のために用いる親水性ポリマー製の二次治癒創傷被覆・保護材をいう。","101002060","ハイドロコロイド材料",-14.42,3952,4.2,{"id":4372,"class_notification":4373,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4374,"code":4375,"generic_name":4376,"generic_name_definition":4377,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":3555,"installation_management":185,"repair_category":4378,"qms_notification":3555,"old_generic_name_code":4379,"old_generic_name":4380,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4381,"growth_ratio":4382,"average_price":4105,"domestic_ratio":4383,"product_count":3765,"company_count":3680,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4346,"3-1109","整形外科手術用器械器具","32882000","整形外科用テープ","カテーテルや輸液チューブなどの医療機器の固定に用いる布製またはプラスティック製の（接着）テープをいう。（副次的に固定するものを除く。）","G9","221299007","その他の整形外科用器械器具",6.38,37.29,16.5,{"id":4385,"class_notification":4386,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4387,"code":4388,"generic_name":4389,"generic_name_definition":4390,"class_classification":3746,"ghtf_rule":4391,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4392,"old_generic_name":4387,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4393,"growth_ratio":4394,"average_price":4395,"domestic_ratio":202,"product_count":204,"company_count":3680,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2918,"2-1717","その他の衛生材料、衛生用品及び関連製品","70978000","分娩時処置用具セット","分娩時、産婦及び新生児に使用することを目的として、消毒､止血､排液除去等の処置を行うために必要なガーゼ、カテーテル等の器具を組み合わせたセットをいう。","5-②","269900002",6.13,-20.68,4954,{"id":4397,"class_notification":4398,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4399,"generic_name":4400,"generic_name_definition":4401,"class_classification":192,"ghtf_rule":4402,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":198,"product_exist":198,"market_size":4404,"growth_ratio":4405,"average_price":4406,"domestic_ratio":3557,"product_count":276,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},268,"1-0268","36197000","ゲル充填人工乳房","乳房再建又は豊胸のために用いる植込み型器具をいう。シェルにはシリコーンゲルを予め充填したもの、一部充填したもの又は術中に充填するものがある。","8-⑧","平成29年3月31日",5.99,-46.22,6.43,{"id":4408,"class_notification":4409,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4410,"generic_name":4411,"generic_name_definition":4412,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4413,"growth_ratio":4414,"average_price":4415,"domestic_ratio":4416,"product_count":4187,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},257,"1-0257","11912200","コラーゲン使用人工皮膚","修復、再建又は治療の目的で皮膚欠損の治療に用いるコラーゲン使用グラフトをいう。",5.94,607.14,857,99.8,{"id":4418,"class_notification":4419,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4420,"generic_name":4421,"generic_name_definition":4422,"class_classification":192,"ghtf_rule":4423,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4424,"growth_ratio":4425,"average_price":4426,"domestic_ratio":4427,"product_count":3680,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},185,"1-0185","70436004","吸収性歯周組織再生用材料","歯周組織の再生を図る目的で、被覆、塗布、充填等によって口腔内の患部に適用される吸収性材料をいう。医薬品を含有することがある。","8-⑤,13",5.78,22.65,1.84,20.5,{"id":740,"class_notification":4429,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4430,"generic_name":4431,"generic_name_definition":4432,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4433,"growth_ratio":4434,"average_price":4435,"domestic_ratio":3990,"product_count":4025,"company_count":4049,"market_size_unit":205,"average_price_unit":3561,"created_at":207},"1-0600","35685003","体内固定用ワイヤ","骨固定に用いる非吸収性植込み型器具をいう。例えば、骨固定を補助する締結ワイヤとして、肘頭、脛骨結節又は大転子等を再接合するための8字ループとして、骨ネジ及び骨プレート固定の補強として、足指又は手指を補強(関節固定)するためのキルシュナー鋼線として、様々な用途で用いる。通常、金属製である。素材は展性があり、長くしたり、コイル状にしたりするものもあれば、硬直・剛性のものもある。",5.73,2.31,5381,{"id":4437,"class_notification":4438,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4439,"generic_name":4440,"generic_name_definition":4441,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4442,"growth_ratio":4443,"average_price":4444,"domestic_ratio":202,"product_count":610,"company_count":204,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2816,"2-1615","38578000","歯科用精密磁性アタッチメント","可撤性補綴物を磁石によって維持する装置をいう。",5.25,-9.12,5563,{"id":183,"class_notification":184,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":189,"generic_name":190,"generic_name_definition":191,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":199,"growth_ratio":200,"average_price":201,"domestic_ratio":202,"product_count":203,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},{"id":4447,"class_notification":4448,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4449,"generic_name":4450,"generic_name_definition":4451,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4452,"growth_ratio":4453,"average_price":4454,"domestic_ratio":3557,"product_count":3874,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},592,"1-0594","34170003","人工椎体","外傷、変形又は変性疾患により1つ又は複数の椎体又は脊椎を欠損した場合に、このうちの1つ又は複数を置換又は修復する器具をいう。通常、金属、ポリマー、他の人工材料、又はこのような物質の組合せを原材料とする。",4.93,31.24,4.65,{"id":4456,"class_notification":4457,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4458,"generic_name":4459,"generic_name_definition":4460,"class_classification":3553,"ghtf_rule":4461,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":926,"last_updated_date":4462,"data_exist":198,"product_exist":198,"market_size":4463,"growth_ratio":4464,"average_price":4465,"domestic_ratio":4466,"product_count":4467,"company_count":3850,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4412,"3-1175","32572000","綿状パッド","神経組織の保護、液の吸収、又は止血のために手術中に用いるコットンまたは合成繊維等のパッドをいう。","4,5-③","平成26年10月22日",4.39,12.55,96,84.8,75,{"id":4469,"class_notification":4470,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4471,"generic_name":4472,"generic_name_definition":4473,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":3555,"installation_management":185,"repair_category":4474,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4475,"growth_ratio":4476,"average_price":4477,"domestic_ratio":4478,"product_count":3680,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},532,"1-0534","70443003","皮膚拡張器","皮下に一定期間植え込み、その周辺部の皮膚を拡張する器具をいう。通常、皮下にバルーンを留置し、生理食塩液等を注入する。","G4",4.33,-44.45,7.01,16.6,{"id":4480,"class_notification":4481,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":4482,"generic_name":4483,"generic_name_definition":4484,"class_classification":197,"ghtf_rule":4485,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4486,"growth_ratio":4487,"average_price":4488,"domestic_ratio":202,"product_count":204,"company_count":204,"market_size_unit":205,"average_price_unit":3561,"created_at":207},1063,"1-1065","71028000","内視鏡用粘膜下注入材","内視鏡的粘膜切除術を施行する際に、病変部位の粘膜下層に注入することにより粘膜層と筋層を解離・隆起させ、その状態を維持し、病変部位の切除又は剥離の操作性を向上させる溶液等をいう。","6-③",4.31,-7.01,2494,{"id":4490,"class_notification":4491,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4492,"generic_name":4493,"generic_name_definition":4494,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":4495,"old_generic_name":4496,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4497,"growth_ratio":4498,"average_price":4467,"domestic_ratio":4499,"product_count":3666,"company_count":2500,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4415,"3-1178","13695000","医療用スポンジ","様々な身体部位に薬物を塗布したり、又は液を除去するために用いるスポンジなどの高分子材料をいう。創傷被覆・保護材を除くものをいう。","260299002","その他の衛生材料",4.07,-19.09,9.1,{"id":4501,"class_notification":4502,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4503,"generic_name":4504,"generic_name_definition":4505,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4506,"growth_ratio":4507,"average_price":4508,"domestic_ratio":202,"product_count":926,"company_count":926,"market_size_unit":205,"average_price_unit":206,"created_at":207},232,"1-0232","32854004","吸収性体内固定用ピン","内外固定や牽引装置を支持したり、軟部組織や靭帯を骨に固定するか、又は骨片を安定化させるために用いる吸収性器具をいう。",3.55,-26.11,1.16,{"id":4510,"class_notification":4511,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4512,"generic_name":4513,"generic_name_definition":4514,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4515,"growth_ratio":4516,"average_price":4517,"domestic_ratio":4518,"product_count":203,"company_count":276,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2251,"2-1048","11323002","局所管理フォーム状創傷被覆・保護材","滲出液が多量な創傷を被覆するために用いる、親水性フォーム製の局所管理用の高吸収性パッドからなる創傷被覆・保護材をいう。",3.35,-35.58,587,11.7,{"id":4520,"class_notification":4521,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4522,"generic_name":4523,"generic_name_definition":4524,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4525,"old_generic_name":4526,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4527,"growth_ratio":4528,"average_price":3687,"domestic_ratio":3557,"product_count":3680,"company_count":3680,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2245,"2-1042","17428000","粘着性透明創傷被覆・保護材","滲出液の少ない創傷を被覆及び保護するために用いる､周縁等が粘着性の透明なポリウレタン等のフィルムをいう。","101002028","粘着フィルム",3.16,-89.32,{"id":4530,"class_notification":4531,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3578,"code":4532,"generic_name":4533,"generic_name_definition":4534,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3748,"old_generic_name":3749,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4224,"data_exist":198,"product_exist":198,"market_size":4535,"growth_ratio":4536,"average_price":4537,"domestic_ratio":3557,"product_count":4049,"company_count":3838,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4430,"3-1193","33584000","液体包帯","皮膚又は口腔内粘膜の傷口を保護又は接合したり、火傷の包帯剤として使用する、液体、半液体又は粉末及び液体を組み合わせた材料をいう。ただし、口腔内粘膜に使用する場合は、一時的又は短期的に使用するものに限る。",3.13,0.77,190,{"id":4539,"class_notification":4540,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4541,"generic_name":4542,"generic_name_definition":4543,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4544,"growth_ratio":4545,"average_price":4546,"domestic_ratio":4547,"product_count":3727,"company_count":286,"market_size_unit":205,"average_price_unit":206,"created_at":207},619,"1-0621","33180000","人工股関節骨セメントレストリクタ","骨セメントの流出を制限するために大腿骨腔の遠位に用いるか、寛骨臼コンポーネントとともに用いる器具をいう。通常、ポリメチルメタクリレート(PMMA)を含有するポリマから作られる。",3.08,-7.3,2.45,18.1,{"id":4549,"class_notification":4550,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4551,"generic_name":4552,"generic_name_definition":4553,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4554,"old_generic_name":4555,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4556,"growth_ratio":4557,"average_price":4558,"domestic_ratio":4177,"product_count":2176,"company_count":3727,"market_size_unit":205,"average_price_unit":206,"created_at":207},582,"1-0584","70496000","全人工肘関節","損傷・変形を来した肘関節の全関節表面を置換又は代用を目的とした人工関節をいう。拘束式、半拘束式又は非拘束式のものがある。ヒンジ等で結合され、ともに関節を形成するように設計された複数のパーツからなるものもある。通常、金属、セラミック、カーボン又はポリマ製等で、（パーツにはこのような材料のいずれか又はすべてを使用している。）又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。","140212086","人工肘関節",3.05,29.62,14.12,{"id":4560,"class_notification":4561,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4562,"generic_name":4563,"generic_name_definition":4564,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4565,"growth_ratio":4566,"average_price":4567,"domestic_ratio":4568,"product_count":3765,"company_count":204,"market_size_unit":205,"average_price_unit":206,"created_at":207},636,"1-0638","37845000","人工指関節","手指、母指又は足指関節を置換するために用いる人工関節をいう。通常、金属、セラミック、カーボン、ポリマ又はこのような物質の組合せを原材料とする。非拘束式、半拘束式又は拘束式のものがあり、セメント固定式のもの又はセメントレスのものがある。",2.96,-25.38,7.65,38.8,{"id":4570,"class_notification":4571,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4572,"generic_name":4573,"generic_name_definition":4574,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4366,"old_generic_name":4367,"old_class_classification":197,"old_repair_category":194,"revision_count":926,"last_updated_date":4575,"data_exist":198,"product_exist":198,"market_size":4576,"growth_ratio":4577,"average_price":4578,"domestic_ratio":202,"product_count":203,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2247,"2-1044","34082002","局所管理ハイドロゲル創傷被覆・保護材","滲出液の吸収、出血又は体液損失の抑制、及び擦過、摩擦、乾燥、汚染からの創傷の保護のために用いる親水性ポリマー製やシリコーンゲル製の局所管理創傷被覆・保護材をいう。","令和4年10月11日",2.9,-8.63,489,{"id":4580,"class_notification":4581,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4582,"generic_name":4583,"generic_name_definition":4584,"class_classification":3553,"ghtf_rule":4585,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4586,"growth_ratio":4587,"average_price":4588,"domestic_ratio":3895,"product_count":454,"company_count":3862,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4163,"3-0926","70914000","歯科咬合スプリント用材料","歯科用咬合スプリントを作製するために用いる材料をいう。ただし、使用期間が30日を超えないものに限る。","5-③",2.44,-4.47,214,{"id":4590,"class_notification":4591,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4592,"generic_name":4593,"generic_name_definition":4594,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4595,"growth_ratio":4596,"average_price":3847,"domestic_ratio":4597,"product_count":2176,"company_count":3777,"market_size_unit":205,"average_price_unit":206,"created_at":207},586,"1-0588","16103003","体内固定用ステープル","整形外科的骨折又は下顎骨骨折等の固定・修復のために、骨折した骨に植え込むU型等の非吸収性器具をいう。靭帯・腱等の構造を骨に止め、固定させるために用いる場合もある。通常、金属製である。",2.35,0.82,58.3,{"id":4599,"class_notification":4600,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4601,"generic_name":4602,"generic_name_definition":4603,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4604,"old_generic_name":4605,"old_class_classification":4606,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4607,"growth_ratio":4608,"average_price":4609,"domestic_ratio":4610,"product_count":203,"company_count":276,"market_size_unit":205,"average_price_unit":3561,"created_at":207},502,"1-0504","43186003","二次治癒親水性ゲル化創傷被覆・保護材","滲出液を吸収して湿潤環境を作り、自己融解デブリドマンを補助する、親水性繊維又はキチン又はアルギン酸塩（塩及び酸）等からなり、通常、シート又はリボン状の二次治癒創傷被覆・保護材をいう。","101002086","生物由来材料","Ⅲ/Ⅳ",2.01,102.33,1681,5.8,{"id":4612,"class_notification":4613,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4614,"generic_name":4615,"generic_name_definition":4616,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":598,"growth_ratio":4617,"average_price":4618,"domestic_ratio":4619,"product_count":203,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},622,"1-0624","34031003","骨プラグ","骨セメントの通路を限定するために、髄腔を密封する閉塞物として用いる非吸収性器具をいう(セメントリストリクタとして使用)。ポリメチルメタクリレート(PMMA)及びポリエチレン(UHMWPE)等を原料とする。金属マーカを導入する場合もある。",71.31,1.83,25.5,{"id":4621,"class_notification":4622,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4623,"generic_name":4624,"generic_name_definition":4625,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4626,"growth_ratio":4627,"average_price":4628,"domestic_ratio":4629,"product_count":3754,"company_count":203,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3815,"3-0578","31071000","皮膚バリア粘着プレート","外部の汚染物質から皮膚部位を保護するために皮膚に粘着する器具をいう。",1.9,55.98,4528,79,{"id":4631,"class_notification":4632,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4633,"generic_name":4634,"generic_name_definition":4635,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4636,"growth_ratio":4637,"average_price":4638,"domestic_ratio":4639,"product_count":3727,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},1102,"1-1104","35241023","患者適合型体内固定用プレート","骨奇形や骨折治療時に骨折間隙を埋め、骨折部位を応力から保護するため、骨折片にネジ等で取り付ける非吸収性植込み型固定器具で、個々の患者に適合するよう設計・製造された器具をいう。病的に骨折した骨の骨延長術、及び頭蓋、顎顔面手術時の補強、又は固定術が必要な関節の融合に用いる場合もある。骨プレートは、通常、金属製、カーボン製等である。",1.88,61.69,8.85,97.4,{"id":4641,"class_notification":4642,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4643,"generic_name":4644,"generic_name_definition":4645,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4646,"growth_ratio":4647,"average_price":4648,"domestic_ratio":3727,"product_count":3765,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},595,"1-0597","35642003","体内固定システム","ケース及び複数のトレイからなる非吸収性器具をいう。多くのインプラント及び専用手術器具を含む。このシステムは骨折手術、脊椎手術、矯正手術又は靭帯再建術等、特定の手術用に設計されている。このシステムを維持するため、インプラントを使用した場合は補充する。",1.29,27.88,6472,{"id":4650,"class_notification":4651,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4652,"generic_name":4653,"generic_name_definition":4654,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4655,"growth_ratio":4656,"average_price":4657,"domestic_ratio":4658,"product_count":3727,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},639,"1-0641","70509000","上肢再建用人工材料","悪性腫瘍等の疾患により広範囲な骨切除を行ったとき、骨欠損部を補綴したり上肢機能を再建するために用いるインプラントをいう。人工関節及びその連結部品、付属品を含む。",1.24,-44.78,47.13,40.4,{"id":4660,"class_notification":4661,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4662,"generic_name":4663,"generic_name_definition":4664,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4125,"growth_ratio":4665,"average_price":4666,"domestic_ratio":4667,"product_count":3727,"company_count":276,"market_size_unit":205,"average_price_unit":206,"created_at":207},621,"1-0623","33982003","骨スペーサ","埋入された人工関節等と骨との間の骨セメント（例えば、ポリメチルメタクリレート(PMMA)）の厚さを確保するために用いる非吸収性器具をいう。通常、ポリマー又は骨セメント材料(PMMA)で成形されている。",-4.07,1.69,74.2,{"id":4669,"class_notification":4670,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4671,"generic_name":4672,"generic_name_definition":4673,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":3801,"growth_ratio":4674,"average_price":4675,"domestic_ratio":4676,"product_count":3850,"company_count":3777,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4410,"3-1173","15085000","開腹術用スポンジ","出血の抑制、液の吸収及び器官の擦過傷防止のため開腹術中に身体内部で用いる器具をいう。",4.16,279,11.5,{"id":4678,"class_notification":4679,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":4680,"generic_name":4681,"generic_name_definition":4682,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4684,"growth_ratio":4685,"average_price":4636,"domestic_ratio":4686,"product_count":203,"company_count":286,"market_size_unit":205,"average_price_unit":206,"created_at":207},2273,"2-1070","70443002","自家植皮拡張器","提供移植片よりも大きな被移植部をカバーする目的で提供移植片を拡張するために用いる機器をいう。提供移植片を様々な拡張比でメッシュする。","6",1.02,-49.69,8.1,{"id":4688,"class_notification":4689,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3781,"code":4690,"generic_name":4691,"generic_name_definition":4692,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3785,"old_generic_name":3786,"old_class_classification":3746,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4693,"growth_ratio":4694,"average_price":4136,"domestic_ratio":4695,"product_count":2500,"company_count":4313,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4407,"3-1170","11661000","アイパッド","ガーゼ又は綿等の様々な材料で製造されたバッドからなる器具をいう。眼の保護又は分泌物の吸収に用いることを目的としている。",0.92,22.51,61.7,{"id":4697,"class_notification":4698,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4699,"generic_name":4700,"generic_name_definition":4701,"class_classification":3553,"ghtf_rule":4585,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4702,"growth_ratio":4703,"average_price":4704,"domestic_ratio":4705,"product_count":3560,"company_count":3914,"market_size_unit":205,"average_price_unit":3561,"created_at":207},4160,"3-0923","36311000","歯科用咬合スプリント","歯牙の咬合面を被覆する硬性又は柔軟性のある器材をいう。転位歯又は動揺歯の位置の保持、クレンチング（噛みしめ癖）や歯ぎしりとその後遺症の治療、及び筋肉又は顎関節の疼痛、例えば顎関節症に対する暫間的な除痛に使用する。ただし、使用期間が30日を超えないものに限る。",0.76,43.89,178,6.8,{"id":4707,"class_notification":4708,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4709,"generic_name":4710,"generic_name_definition":4711,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4712,"growth_ratio":4713,"average_price":4714,"domestic_ratio":4715,"product_count":3680,"company_count":286,"market_size_unit":205,"average_price_unit":206,"created_at":207},618,"1-0620","33179000","人工股関節寛骨臼サポートコンポーネント","寛骨臼サポートリング、シート又はメッシュ等の形状の器具をいう。寛骨臼を損傷した場合に人工寛骨臼コンポーネントを支持するために用いる。通常、金属又はポリマ製である。",0.73,4.45,8.29,38.2,{"id":4717,"class_notification":4718,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4719,"generic_name":4720,"generic_name_definition":4721,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4604,"old_generic_name":4605,"old_class_classification":4606,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":4722,"growth_ratio":3557,"average_price":4723,"domestic_ratio":4724,"product_count":598,"company_count":598,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2249,"2-1046","43186002","局所管理親水性ゲル化創傷被覆・保護材","滲出液を吸収して湿潤環境を作り、自己融解デブリドマンを補助する、親水性繊維又はキチン又はアルギン酸塩（塩及び酸）等からなり、通常、シート又はリボン状の局所管理創傷被覆・保護材をいう。",0.42,4764,59.6,{"id":4726,"class_notification":4727,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4728,"generic_name":4729,"generic_name_definition":4730,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4731,"growth_ratio":4732,"average_price":4733,"domestic_ratio":4734,"product_count":3874,"company_count":276,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2815,"2-1614","38577000","歯科用精密バーアタッチメント","既製の金属バー及び鉤、スリーブ、螺子等からなり、バー型装置へ可撤性補綴物を固定するために用いる装置をいう。",0.4,-3.7,6760,47.6,{"id":4736,"class_notification":4737,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4738,"generic_name":4739,"generic_name_definition":4740,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4741,"growth_ratio":4742,"average_price":1124,"domestic_ratio":3557,"product_count":4049,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2829,"2-1628","70924000","歯科根管ポスト成形品キット","既製のポスト又はロッド、ドリル、レンチ、ゲージ等から成るキットをいう。歯科根管形成後、ポスト又はロツドを根管に挿入し、強化する。ポストを植立させるため、前処理としてドリル、レンチ、ゲージ等を用いる。",0.26,73.23,{"id":4744,"class_notification":4745,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4746,"generic_name":4747,"generic_name_definition":4748,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":4741,"growth_ratio":3557,"average_price":4684,"domestic_ratio":4749,"product_count":276,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},1038,"1-1040","34006003","非吸収性歯科用骨再建インプラント材","顎骨内の欠損部を満たしたり(充填)、顎骨の築盛(補強)のための歯科治療に用いる非吸収性の生体材料をいう。",59.4,{"id":4751,"class_notification":4752,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4753,"generic_name":4754,"generic_name_definition":4755,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4741,"growth_ratio":4756,"average_price":4757,"domestic_ratio":4758,"product_count":4187,"company_count":286,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3812,"3-0575","11322101","熱傷被覆・保護材","熱傷皮膚を被覆及び保護し、熱傷部位の滲出液を吸収するために用いる幅広の層状ガーゼパッドをいう。",-1.44,632,82.1,{"id":4760,"class_notification":4761,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4762,"generic_name":4763,"generic_name_definition":4764,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4765,"growth_ratio":4766,"average_price":4767,"domestic_ratio":4768,"product_count":3914,"company_count":4187,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2818,"2-1617","38603000","歯科用精密弾性アタッチメント","歯牙負担又は粘膜負担義歯において、支台に過剰な力が加わらないよう、床下粘膜の変形による義歯の変位を吸収できる十分な遊びを与えるように設計されたアタッチメントをいう。",0.24,59.46,4708,20.7,{"id":4770,"class_notification":4771,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4772,"generic_name":4773,"generic_name_definition":4774,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3648,"old_generic_name":3649,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4775,"growth_ratio":3557,"average_price":4776,"domestic_ratio":3557,"product_count":598,"company_count":598,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3796,"3-0559","16006000","血管造影用サージカルドレープ","血管造影時に使用する専用のカバーをいう。本品は単回使用である。",0.23,2447,{"id":4778,"class_notification":4779,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4780,"generic_name":4781,"generic_name_definition":4782,"class_classification":3553,"ghtf_rule":4783,"specific_maintenance":3555,"installation_management":185,"repair_category":4378,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4784,"growth_ratio":4785,"average_price":4786,"domestic_ratio":3557,"product_count":3727,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},3814,"3-0577","13371000","臓器固定器","一方の端に紐又はコードの付いた幅広の薄く平坦なパット又はネットをいい、多くは柔軟なプラスチック製である。本器具は、器官を適所に保持するために使用され、一時的に手術部位内に植込まれる場合もある。本品は単回使用である。","6-①",0.22,-23.86,1613,{"id":3590,"class_notification":4788,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4789,"generic_name":4790,"generic_name_definition":4791,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":4036,"market_size":4792,"growth_ratio":4793,"average_price":4794,"domestic_ratio":4795,"product_count":3557,"company_count":3557,"market_size_unit":205,"average_price_unit":3561,"created_at":207},"1-0241","36198004","吸収性体内固定用ワッシャ","固定力の向上又は軟部組織の損傷防止のために、骨ネジ又は骨ボルト等の骨固定器具と共に用いる吸収性器具をいう。",0.19,19.96,8536,92.2,{"id":4797,"class_notification":4798,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4799,"generic_name":4800,"generic_name_definition":4801,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4802,"growth_ratio":4803,"average_price":4804,"domestic_ratio":4805,"product_count":4187,"company_count":204,"market_size_unit":205,"average_price_unit":3561,"created_at":207},601,"1-0603","36198003","体内固定用ワッシャ","固定力の向上又は軟部組織の損傷防止のために、骨ネジ又は骨ボルト等の骨固定器具と共に用いる非吸収性器具をいう。通常、金属、ポリマー又は強化ポリマー製である。",0.18,-72.59,2631,37.5,{"id":4807,"class_notification":4808,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4809,"generic_name":4810,"generic_name_definition":4811,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4812,"growth_ratio":4813,"average_price":4814,"domestic_ratio":3557,"product_count":3680,"company_count":3680,"market_size_unit":205,"average_price_unit":3561,"created_at":207},596,"1-0598","70500000","頭蓋骨固定用クランプ","閉頭術後に頭蓋骨を閉鎖するため、または頭蓋骨片の複雑骨折による転位の整復のため、頭蓋骨片を挟み込んで固定する非吸収性植込み型固定器具をいう。プレートやディスクとそれに付属するピンなどにより固定を行う。通常、金属製、ステンレススチール製、チタン製等である。",0.11,-52.41,7904,{"id":4816,"class_notification":4817,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4818,"generic_name":4819,"generic_name_definition":4820,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4821,"growth_ratio":4822,"average_price":4823,"domestic_ratio":4090,"product_count":3727,"company_count":3727,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2814,"2-1613","38576000","歯科用精密ボールアタッチメント","球状雄部と環状雌部の2つの部分から構成されるアタッチメントをいう。",0.09,-32.16,2635,{"id":4825,"class_notification":4826,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4827,"generic_name":4828,"generic_name_definition":4829,"class_classification":3746,"ghtf_rule":4830,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3820,"old_generic_name":3821,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4821,"growth_ratio":3557,"average_price":4831,"domestic_ratio":3557,"product_count":598,"company_count":598,"market_size_unit":205,"average_price_unit":3561,"created_at":207},2370,"2-1167","36071000","気管切開用スピーチバルブ","気管切開チューブに接続し、用指的な閉鎖の必要性を排除することを目的とした器具をいう。気管切開患者が容易にかつ明瞭に話すことを可能にする。","5-⑤",5304,{"id":4833,"class_notification":4834,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4835,"generic_name":4836,"generic_name_definition":4837,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4554,"old_generic_name":4555,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4838,"growth_ratio":3557,"average_price":4839,"domestic_ratio":3557,"product_count":276,"company_count":3680,"market_size_unit":205,"average_price_unit":206,"created_at":207},579,"1-0581","33701000","人工肘関節橈骨コンポーネント","近位橈骨の関節表面を補強又は置換する金属又はポリマー製等の人工関節をいう。拘束式又は非拘束式人工肘関節の一部をなすものもある。",0.04,7.49,{"id":574,"class_notification":4841,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4842,"generic_name":4843,"generic_name_definition":4844,"class_classification":3553,"ghtf_rule":4845,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4846,"growth_ratio":3557,"average_price":4847,"domestic_ratio":202,"product_count":203,"company_count":276,"market_size_unit":205,"average_price_unit":3561,"created_at":207},"3-0584","70446000","創傷面積測定器","創傷の面積を測定及び記録するため用いる器具機械。創傷の大きさを測定するための記録シート等からなる。記録シートは創の面積を算出するために面積計算機と組み合わせて用いることもある。損傷皮膚に接触する場合には滅菌済みで単回使用とする。","12",0.02,1751,{"id":4849,"class_notification":4850,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4851,"generic_name":4852,"generic_name_definition":4853,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4846,"growth_ratio":4854,"average_price":4855,"domestic_ratio":3557,"product_count":286,"company_count":286,"market_size_unit":205,"average_price_unit":206,"created_at":207},607,"1-0609","70501000","骨固定バンド","骨と軟部組織の締結・縫合、骨とインプラントの固定、骨と骨の固定などに用いるワイヤ、ケーブル、バンド等をいう。金属製又はポリマー製である。",-56.9,2.47,{"id":4857,"class_notification":4858,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4859,"generic_name":4860,"generic_name_definition":4861,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3524,"old_generic_name":3525,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":198,"product_exist":198,"market_size":4862,"growth_ratio":4863,"average_price":4864,"domestic_ratio":3557,"product_count":598,"company_count":598,"market_size_unit":205,"average_price_unit":206,"created_at":207},566,"1-0568","33717000","表面置換型人工股関節","大腿骨骨頭及び寛骨臼の関節面の再建に用いる人工関節をいう。金属、ポリマー、カーボン及びセラミック等を原材料とする。大腿骨コンポーネントには差込部を備えたものもある。",0.01,485.19,22.43,{"id":4866,"class_notification":4867,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4868,"generic_name":4869,"generic_name_definition":4870,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},187,"1-0187","70437304","歯科用コラーゲン使用骨再生材料","骨組織の再生を図る目的で被覆、塗布、充填等によって口腔内の患部に適用される材料で、コラーゲンを含有するものをいう。",{"id":4872,"class_notification":4873,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4874,"generic_name":4875,"generic_name_definition":4876,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4877,"old_generic_name":4878,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},180,"1-0180","34164100","軟組織接合用接着剤","傷の治癒を促進させるために傷口の接着に用いる生体適合性の接着剤をいい、アクリル酸塩又は他の合成物質より成る。","101008004","外科用接着剤",{"id":4880,"class_notification":4881,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4882,"generic_name":4883,"generic_name_definition":4884,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},228,"1-0228","16077004","吸収性体内固定用ボルト","牽引装置など類似の装置に安全性を付与するために、骨に挿入する吸収性器具をいう。ナットで固定し、ワッシャーを備えたものもある。",{"id":4886,"class_notification":4887,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4888,"generic_name":4889,"generic_name_definition":4890,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},230,"1-0230","16103004","吸収性体内固定用ステープル","整形外科的骨折又は下顎骨骨折等の固定・修復のために、骨折した骨に植え込むU型等の吸収性器具をいう。靭帯・腱等の構造を骨に止め、固定させるために用いる場合もある。",{"id":4892,"class_notification":4893,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4894,"generic_name":4895,"generic_name_definition":4896,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},236,"1-0236","70498000","吸収性体内固定用タック","骨固定用の器具で、骨折治療時等に使用されるプレート等を固定するために用いる吸収性の器具をいう。",{"id":3791,"class_notification":4898,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4899,"generic_name":4900,"generic_name_definition":4901,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0237","70499000","吸収性体内埋植用シート","骨欠損部等の被覆又は支持に用いる吸収性の器具をいう。複数の穴を有するものもある。",{"id":4903,"class_notification":4904,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4905,"generic_name":4906,"generic_name_definition":4907,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},238,"1-0238","35642004","吸収性体内固定システム","ケース及び複数のトレイからなる吸収性器具をいう。多くのインプラント及び専用手術器具を含む。このシステムは骨折手術、脊椎手術、矯正手術又は靭帯再建術等、特定の手術用に設計されている。このシステムを維持するため、インプラントを使用した場合は補充する。",{"id":4909,"class_notification":4910,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4911,"generic_name":4912,"generic_name_definition":4913,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},1037,"1-1039","34006009","歯科用骨再建インプラント材","歯科治療で顎骨内の欠損部の充填や顎骨の築盛(補強)のために用いる吸収性又は非吸収性の生体材料をいう。ただし「非吸収性歯科用骨再建インプラント材」及び「吸収性歯科用骨再建インプラント材」を除く。",{"id":4915,"class_notification":4916,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4917,"generic_name":4918,"generic_name_definition":4919,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},1041,"1-1043","42349000","歯科用粘膜下埋植型インプラント材","歯肉又は粘膜に完全に覆われる歯科用インプラントをいう。",{"id":4921,"class_notification":4922,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4923,"generic_name":4924,"generic_name_definition":4925,"class_classification":192,"ghtf_rule":4926,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},248,"1-0248","32869004","吸収性人工腱","欠損又は損傷した腱の機能を回復するために置換又は修復することを目的とした植込み型器具をいう。本品は吸収性材料製である。","8,8-④",{"id":4928,"class_notification":4929,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4930,"generic_name":4931,"generic_name_definition":4932,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},253,"1-0253","15794000","強膜バックリング用器具","強膜に挿入する吸収性の器具で、網膜復位を補助するために用いるものをいう。",{"id":4934,"class_notification":4935,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4936,"generic_name":4937,"generic_name_definition":4938,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},261,"1-0261","35614000","髄膜用補綴材","髄膜の修復に用いる生物学的器具又は人工器具をいう。",{"id":4940,"class_notification":4941,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4942,"generic_name":4943,"generic_name_definition":4944,"class_classification":192,"ghtf_rule":4945,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},269,"1-0269","38746000","異種移植片グラフト","異種動物間(ヒトを含む)で移植する組織のグラフトをいう。","8-④,14",{"id":4947,"class_notification":4948,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4949,"generic_name":4950,"generic_name_definition":4951,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4205,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},270,"1-0270","70510000","ヒト合成人工硬膜","開放性頭部外傷や外傷性髄液瘻に続発して硬膜の欠損が生じた場合、あるいは開頭手術で硬膜の一部を切除する必要が生じた場合、硬膜補填もしくは硬膜代用のために使用する人工膜をいう。吸収性と非吸収性とがある。非吸収性膜は、脳表面と硬膜との癒着防止を目的として使用されることもある。",{"id":4953,"class_notification":4954,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4955,"generic_name":4956,"generic_name_definition":4957,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},1043,"1-1045","42352000","歯科用骨膜下インプラント材","骨膜と骨表面との間に埋植する歯科用インプラントをいう。",{"id":430,"class_notification":4959,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4960,"generic_name":4961,"generic_name_definition":4962,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-1046","42353000","歯科用経根管及び経歯根インプラント材","歯根管又は歯根を経由して骨に挿入するために用いるロッド型インプラントをいう。",{"id":4964,"class_notification":4965,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":4966,"generic_name":4967,"generic_name_definition":4968,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1045,"1-1047","42354000","歯科用経歯肉インプラント材","歯科補綴物の脱離を防止するために、粘膜を経由して口腔内へ伸びる支台構造をもった歯科用インプラントをいう。",{"id":4970,"class_notification":4971,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4972,"generic_name":4973,"generic_name_definition":4974,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},243,"1-0243","38161004","吸収性脊椎ケージ","椎間板又は脊椎の一部の代わりに脊柱構造の高さを置換、矯正又は修復するために用いる器具をいう。通常、吸収性材料を原材料とする。",{"id":4976,"class_notification":4977,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4978,"generic_name":4979,"generic_name_definition":4980,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1084,"1-1086","31744024","中心循環系非吸収性局所止血材","中心循環系血管の止血のために、外科切開口、皮膚創傷又は内部構造に適用する、非吸収性の器具をいう。",{"id":934,"class_notification":4982,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4983,"generic_name":4984,"generic_name_definition":4985,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4554,"old_generic_name":4555,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0582","35664000","人工肘関節上腕骨コンポーネント","遠位上腕骨関節表面の一部又は全体を補強又は置換する金属、ポリマー、セラミック製等の上腕骨コンポーネントをいう。セメント固定式のもの又はセメントレスのものがある。拘束式又は非拘束式人工肘関節の一部をなすものもある。",{"id":929,"class_notification":4987,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":4988,"generic_name":4989,"generic_name_definition":4990,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-1102","35895324","ヒトトロンビン含有ゼラチン使用吸収性局所止血材","止血のために、外科切開口、皮膚創傷又は内部構造に適用する、身体に吸収される素材からなるヒトトロンビン含有のゼラチン使用器具をいう。接着効果があるものもある。",{"id":4517,"class_notification":4992,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4993,"generic_name":4994,"generic_name_definition":4995,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0589","32847003","体内固定用ナット","骨ネジ又は骨ボルト等の骨固定器具とともに用い、固定力を向上させることを目的とする非吸収性器具をいう。骨孔がネジ径より大きい場合に用いることもある。",{"id":4997,"class_notification":4998,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":4999,"generic_name":5000,"generic_name_definition":5001,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},593,"1-0595","34219000","人工肋骨","肋骨全部又は一部を置換又は修復する器具をいう。通常、金属、ポリマー、他の人工材料又は生物学的材料、又はこのような物質の組合せを原材料とする。",{"id":5003,"class_notification":5004,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5005,"generic_name":5006,"generic_name_definition":5007,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},608,"1-0610","70503000","頭部プロテーゼ固定用材料","義眼・義鼻・義耳等の頭部プロテーゼ（顔面補綴物）を顔面に固定するために用いる材料をいう。頭蓋骨に固定するプレート、スクリュー等と、固定用の支柱（アンカー）等から構成される。",{"id":5009,"class_notification":5010,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5011,"generic_name":5012,"generic_name_definition":5013,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},610,"1-0612","70506000","仙骨止血ピン","仙骨前血管の多量出血をコントロールするために用いる埋め込み型器具をいう。画鋲様の形状で金属製（主にチタン）である。",{"id":5015,"class_notification":5016,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5017,"generic_name":5018,"generic_name_definition":5019,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},659,"1-0661","31998000","尿管膀胱用補綴材","尿管壁に植え込む体内器具をいう。尿管壁の量及び張力を増大させて括約筋の機能を支持する。通常、シリコーンゴム又はテフロン等の非吸収性ポリマー製で、カテーテルを用いて適用することがきる。",{"id":5021,"class_notification":5022,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5023,"generic_name":5024,"generic_name_definition":5025,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},684,"1-0686","36251000","ロッド型人工陰茎","勃起陰萎に適用される体内器具をいう。永久的な膨張性及び硬直性を得るために用いる。シリコーンゴム又は他のポリマーを原材料とし、1つ又は複数のロッドの形状をもつ。金属で補強したものもあり、硬質又は半硬質のものがある。",{"id":5027,"class_notification":5028,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5029,"generic_name":5030,"generic_name_definition":5031,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},685,"1-0687","36291000","角膜内リング","角膜に挿入することにより角膜曲率を扁平化して近視などの屈折異常を矯正するリング状の機器をいう。",{"id":5033,"class_notification":5034,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5035,"generic_name":5036,"generic_name_definition":5037,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1136,"1-1138","71057003","甲状軟骨固定用器具","声帯機能不全患者の喉頭形成手術時に使用され、切開した甲状軟骨の開大維持を目的とした固定用器具をいう。通常、金属製である。",{"id":5039,"class_notification":5040,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5041,"generic_name":5042,"generic_name_definition":5043,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},1085,"1-1087","70500004","吸収性頭蓋骨固定用クランプ","閉頭術後に頭蓋骨を閉鎖するため、または頭蓋骨片の複雑骨折による転位の整復のため、頭蓋骨片を挟み込んで固定する吸収性植込み型固定器具をいう。プレートやディスクとそれに付属するピンなどにより固定を行う。",{"id":5045,"class_notification":5046,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5047,"generic_name":5048,"generic_name_definition":5049,"class_classification":192,"ghtf_rule":5050,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},1141,"1-1143","71062004","植込み医療機器用吸収性スペーサ","体内に一時的又は永久的に留置される機械器具と組み合わせて使用する吸収性器具をいう。機械器具を目的の間隔で配置するためのスペーサとして使用されるほか、視認性を向上させること等を意図して使用されることもある。別に名称を定めたものを除く。","7-④,8-⑤",{"id":5052,"class_notification":5053,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5054,"generic_name":5055,"generic_name_definition":5056,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1173,"1-1175","47021003","椎体用支持材料","拡張して椎体の内側に留まる支持構造で、骨折部位の椎体高を復元すること及び椎体内に整形外科用骨セメント注入用のキャビティを形成することを目的とする支持材料をいう。例えば、カテーテルによって骨折椎体に送達し、バルーンカテーテルの膨張、又は自己拡張により、支持材料は拡張して骨折椎体を支持する。カテーテルを抜去すると、支持材料は永久インプラントとしてその位置に留まる。",{"id":13,"class_notification":5058,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5059,"generic_name":5060,"generic_name_definition":5061,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-1185","65105004","ヒト羊膜使用組織治癒促進用材料","組織治癒促進の目的で患部に適用されるヒト羊膜由来の同種移植片である。なお、絨毛膜等羊膜以外の組織を含むものもある。",{"id":731,"class_notification":5063,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5064,"generic_name":5065,"generic_name_definition":5066,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-1189","60907004","コラーゲン使用吸収性腱再生材","腱組織の再生を促進させる目的で、被覆等によって患部に適用される吸収性材料で、コラーゲンを含有するものをいう。",{"id":5068,"class_notification":5069,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5070,"generic_name":5071,"generic_name_definition":5072,"class_classification":192,"ghtf_rule":5073,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},1155,"1-1157","45829004","コラーゲン使用吸収性人工硬膜","開放性頭部外傷や外傷性髄液瘻に続発して硬膜の欠損が生じた場合、あるいは開頭手術で硬膜の一部を切除する必要の生じた場合の硬膜補填もしくは硬膜代用する、身体に吸収される素材からなるコラーゲン使用人工膜をいう。","8-②,8-⑤,14",{"id":5075,"class_notification":5076,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5077,"generic_name":5078,"generic_name_definition":5079,"class_classification":197,"ghtf_rule":5080,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},10136,"1-1207","61370003","薬剤溶出型吸収性副鼻腔用ステント","拡張して副鼻腔の内側に留まる吸収性の支持構造で、その開存性を維持するために用いる薬剤溶出型ステントをいう。例えば、内視鏡下でデリバリシステムによって、副鼻腔内に送達することができる。自己拡張により、ステントは拡張して内腔を支持する。","5-④, 13",{"id":5082,"class_notification":5083,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5084,"generic_name":5085,"generic_name_definition":5086,"class_classification":192,"ghtf_rule":3672,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},171,"1-0171","35717004","吸収性人工靭帯","欠損又は損傷した靭帯構造の機能回復のために置換又は修復を目的とした植込み型器具をいう。本品は吸収性材料製である。",{"id":5088,"class_notification":5089,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5090,"generic_name":5091,"generic_name_definition":5092,"class_classification":197,"ghtf_rule":5093,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4236,"old_generic_name":4237,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},504,"1-0506","70432000","穿刺部保護パッチ","出血の抑制、液の吸収、又は汚染からの保護のため、皮膚穿刺部を保護する抗微生物薬含浸のパッチをいう。抗微生物薬はバッチ内の菌の増殖を防ぐ用途で用いられている。","4,13",{"id":5095,"class_notification":5096,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5097,"generic_name":5098,"generic_name_definition":5099,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1169,"1-1171","71083003","耳管用補綴材","耳管内腔径を適切に保つために留置する器具をいう。",{"id":5101,"class_notification":5102,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5103,"generic_name":5104,"generic_name_definition":5105,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2250,"2-1047","10516000","熱傷キット","Ⅰ度又はⅡ度の熱傷を治療するために組み合わせて用いる、包帯剤、抗生物質等の必要品を集めたパッケージをいう。",{"id":3691,"class_notification":5107,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5108,"generic_name":5109,"generic_name_definition":5110,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4877,"old_generic_name":4878,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0179","33511000","動脈瘤形成術用組織接着剤","嚢を接着・閉鎖する方法で動脈瘤を修復するために用いる膠又は樹脂等の物質をいう。",{"id":5112,"class_notification":5113,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5114,"generic_name":5115,"generic_name_definition":5116,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},231,"1-0231","32847004","吸収性体内固定用ナット","骨ネジ又は骨ボルト等の骨固定器具とともに用い、固定力を向上させることを目的とする吸収性器具をいう。骨孔がネジ径より大きい場合に用いることもある。",{"id":5118,"class_notification":5119,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5120,"generic_name":5121,"generic_name_definition":5122,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2252,"2-1049","13886000","手術用パッキング","円筒状のガーゼをいう。多種類の幅で、ワセリンまたはポビドンヨードなどを含浸させたガーゼで、手術切開部に詰めて用いる。",{"id":5124,"class_notification":5125,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5126,"generic_name":5127,"generic_name_definition":5128,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3648,"old_generic_name":3649,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},2253,"2-1050","44273000","創傷保護リング","中心に穴の開いた円形のプラスチック製カバーをいう。手術創周囲の皮膚に接着するか創傷の露出部分を覆うことにより当該部位を保護する。サージカルドレープを保持するために用いることもできる。",{"id":5130,"class_notification":5131,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5132,"generic_name":5133,"generic_name_definition":5134,"class_classification":3746,"ghtf_rule":5135,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2255,"2-1052","10459000","ボーンワックス","術中に骨からの出血を遮断するために用いる含ろうスティック、ペースト、ソース又は軟膏をいう。以前は精製した密ろうを原料としていたが、現在では合成ろうから作ることができる。","7",{"id":5137,"class_notification":5138,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5139,"generic_name":5140,"generic_name_definition":5141,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2256,"2-1053","35118000","切開・ドレナージキット","身体に開口部を造りドレーンを配置するために用いる外科用メス及びチューブを含む用具を集めたパッケージをいう。本品は単回使用である。",{"id":5143,"class_notification":5144,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5145,"generic_name":5146,"generic_name_definition":5147,"class_classification":3746,"ghtf_rule":4391,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":598,"last_updated_date":4205,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},2257,"2-1054","70224002","子宮操作用セット","子宮を操作しながら、薬液などを注入・排出するために使用するセットをいう。バルーン付カテーテル、シリンジ、チューブ、カテーテル等から成る。",{"id":5149,"class_notification":5150,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5151,"generic_name":5152,"generic_name_definition":5153,"class_classification":3746,"ghtf_rule":5135,"specific_maintenance":3555,"installation_management":185,"repair_category":5154,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2261,"2-1058","16065000","眼科用コンフォーマ","通常、成形プラスチックから作られ、眼球摘出後の治癒時に眼窩の空間を保持し閉鎖又は癒着を防ぐために、眼球と眼瞼との間に一時的に挿入することを目的とした眼科用機器をいう。","G5",{"id":5156,"class_notification":5157,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5158,"generic_name":5159,"generic_name_definition":5160,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2266,"2-1063","34945000","単回使用環状切除キット","環状切除術に必要な各種の装置、被覆保護材または医薬品を全てプレパッケージしたキット、セット又はトレイをいう。通常、消毒薬、環状切除クランプ、せん刀、及び外科用メス等が含まれる。本品は単回使用である。",{"id":5162,"class_notification":5163,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5164,"generic_name":5165,"generic_name_definition":5166,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":3555,"installation_management":185,"repair_category":5154,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2269,"2-1066","37069000","眼内空気置換装置","眼科手術時に網膜復位又は網膜下液の排除を目的として、眼内に少量の空気を注入するために用いる機器をいう。",{"id":5168,"class_notification":5169,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5170,"generic_name":5171,"generic_name_definition":5172,"class_classification":3746,"ghtf_rule":5173,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2371,"2-1168","43989000","植込み用注射筒","塞栓形成インプラント等の他の器具を体内に植え込むためのネジ山つきのプランジャ及び圧力ゲージを備えた中空の容器をいう。本品は誘導管（適切なカテーテル等）を用いて外科的に標的部位に配置したのちに、植込み型器具を準備（パージング）し、送り出すための圧力を正確にコントロールする。プランジャにはさらにコントロールするためのロック機構があり、本品には軟性の高圧延長チューブが装備されている。圧力ゲージによりパージング、器具の配置及び器具の分離（送り出し）の設定が容易にできる。本品は単回使用である。","5-①,6",{"id":5175,"class_notification":5176,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5177,"generic_name":5178,"generic_name_definition":5179,"class_classification":3746,"ghtf_rule":5135,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2372,"2-1169","31995002","短期的使用輸精管用補綴材","短期的使用を目的として、副睾丸から尿道に精子を輸送する管の損傷部又は閉塞部の修復のために用いる器具をいう。",{"id":5181,"class_notification":5182,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5183,"generic_name":5184,"generic_name_definition":5185,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4205,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},260,"1-0260","33473204","体内用吸収性合成・炭素繊維補綴材","炭素繊維で補強したポリテトラフルオロエチレン(PTFE)から成り、吸収性インプラント用複合材料を作製するためのものをいう。美容外科で顎、鼻又は眼周囲の骨及び組織の形状の修復に用いることができる。",{"id":5187,"class_notification":5188,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5189,"code":5190,"generic_name":5191,"generic_name_definition":5192,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5193,"old_generic_name":5194,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2796,"2-1595","歯科合着､充填及び仮封材料","44406000","歯科用救急キット","歯科において不慮の事故が発生した場合に使用する器具や材料を集めたセットをいう。緊急時に、一般のユーザが歯科医の支援なしで暫定的に修復するために必要な製品が含まれる。脱落したクラウン、ブリッジ、充填物及びインレーを再装着し、外観及び機能の回復を図る。本品は単回使用であるが、さまざまな目的に用いることができる。","200899000","その他の歯科合着､充填及び仮封材料",{"id":5196,"class_notification":5197,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":5198,"generic_name":5199,"generic_name_definition":5200,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},2813,"2-1612","35868000","歯科用保持ピン","歯科修復物を保持又は安定させるため、歯牙に永久的に植立するために用いる器具をいう。",{"id":5202,"class_notification":5203,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5204,"generic_name":5205,"generic_name_definition":5206,"class_classification":197,"ghtf_rule":4485,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5207,"old_generic_name":5208,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},505,"1-0507","32376000","吸収性ガーゼ","手術中に使用して身体に吸収することを目的とする、酸化セルロースから成る軽く織目の粗い滅菌ガーゼをいう。","101002129","吸収性創傷被覆・保護材",{"id":5210,"class_notification":5211,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5212,"generic_name":5213,"generic_name_definition":5214,"class_classification":197,"ghtf_rule":5215,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},529,"1-0531","70436003","非吸収性歯周組織再生用材料","歯周組織の再生を図る目的で、被覆、塗布、充填等によって口腔内の患部に適用される非吸収性材料をいう。医薬品を含有することがある。","8,13",{"id":5217,"class_notification":5218,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5219,"generic_name":5220,"generic_name_definition":5221,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3869,"old_generic_name":3870,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},611,"1-0613","16131000","頭蓋用レジン様化合物","脳神経外科手術後、頭蓋骨を再構築するために用いるレジン様物質をいう。",{"id":5223,"class_notification":5224,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5225,"generic_name":5226,"generic_name_definition":5227,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5228,"old_generic_name":5229,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},645,"1-0647","33794000","中耳腔換気用チューブ","耳の鼓膜の機能の置換又は修復に用いる器具をいう。","140214040","人工鼓膜",{"id":5231,"class_notification":5232,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5233,"generic_name":5234,"generic_name_definition":5235,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},654,"1-0656","31038000","鼻用補綴材","鼻の美容性又は機能性を回復させるために(鼻)顔面組織に挿入する器具をいう。通常、高分子材料製である。",{"id":5237,"class_notification":5238,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5239,"generic_name":5240,"generic_name_definition":5241,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},663,"1-0665","34000000","眼強膜補綴材","強膜欠損部の補強又は修復に用いる器具をいう。",{"id":5243,"class_notification":5244,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5245,"generic_name":5246,"generic_name_definition":5247,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},526,"1-0528","35660000","眼筋スリーブ","眼筋の包み込み又は分離に用いる合成材料製の機器をいう。",{"id":5249,"class_notification":5250,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5251,"generic_name":5252,"generic_name_definition":5253,"class_classification":197,"ghtf_rule":5254,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},664,"1-0666","34092000","人工肛門括約筋補綴材","糞便失禁の再コントロールにより機能を回復するために用いる器具をいう。","5-④",{"id":5256,"class_notification":5257,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5258,"code":5259,"generic_name":5260,"generic_name_definition":5261,"class_classification":197,"ghtf_rule":5262,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1203,"1-1205","その他の眼科用品及び関連製品","71130003","眼科用視野確保材","緑内障観血的手術時に、観察領域または処置領域に塗布することにより、視野の確保、観察及び処置の支援に用いるものをいう。","5-③'",{"id":5264,"class_notification":5265,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5266,"generic_name":5267,"generic_name_definition":5268,"class_classification":197,"ghtf_rule":5254,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},520,"1-0522","42839000","眼科用嚢内リング","毛様小体が弱いか存在しない場合に亜脱臼水晶体嚢の機械的安全性を強化するために用いる環状バンドをいう。水晶体嚢に埋め込み、張力を生じさせて水晶体嚢を伸ばしておく。",{"id":5270,"class_notification":5271,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5272,"generic_name":5273,"generic_name_definition":5274,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},1096,"1-1098","71034004","コラーゲン使用吸収性神経再生誘導材","外傷等による末梢神経断裂・欠損部に導入して両断端に連続性を持たせ、神経再生の誘導と機能再建を目的とした、身体に吸収されるコラーゲン使用器具をいう。",{"id":5276,"class_notification":5277,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5278,"generic_name":5279,"generic_name_definition":5280,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1075,"1-1077","17876013","膀胱尿管逆流症治療用注入材","主成分の膨隆形成物質としてデキストラノマービーズ等を含有している注入材で、膀胱尿管逆流症の治療を目的として、膀胱鏡下で経尿道的に、膀胱内の尿管口近傍又は壁内尿管の粘膜下に注入するものをいう。",{"id":5282,"class_notification":5283,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3578,"code":5284,"generic_name":5285,"generic_name_definition":5286,"class_classification":3746,"ghtf_rule":4830,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},3208,"2-2007","60371002","家庭用鼻腔粘膜保護材","抗原等から鼻腔の粘膜を保護する吸収されにくい材料で、長期に使用するものをいう。",{"id":5288,"class_notification":5289,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5290,"generic_name":5291,"generic_name_definition":5292,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3648,"old_generic_name":3649,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},3798,"3-0561","36008000","レーザ抵抗性サージカルドレープ","典型的な外科的レベルのレーザーエネルギーに対する保護を目的とした材料で特別な加工又はコーティーングを施したサージカルドレープをいう。器具、装置又は患者の保護に用いることができる。",{"id":5294,"class_notification":5295,"specific_maintenance_notification":5296,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5297,"generic_name":5298,"generic_name_definition":5299,"class_classification":3553,"ghtf_rule":5300,"specific_maintenance":3583,"installation_management":185,"repair_category":4474,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},3811,"3-0574","1181","44039000","薬剤付再使用可能な救急キット","非常時の損傷の初期段階治療のための器具、材料及び薬剤を集めた便利な一式をいう。通常、病院、施設、救急車サービス、人が多い場所等で使用する。本品には別々に使用すると薬剤となる薬物・コンポーネントが含まれる。再使用可能な品目を適切に洗浄し、消耗品を補充したのちに再使用することができる。","4,6-①",{"id":5302,"class_notification":5303,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5304,"generic_name":5305,"generic_name_definition":5306,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":3680,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},3816,"3-0579","34084000","圧迫性被覆・保護材","体液の貯留予防を目的に、患部に圧力を加えるために用いる被覆材をいう。最も一般的には植皮部、及び熱傷治療に用いる。",{"id":5308,"class_notification":5309,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5310,"generic_name":5311,"generic_name_definition":5312,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":3553,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},3920,"3-0683","70507000","骨セメント用脱気チューブ","骨セメントの使用時に気体を除去するために用いるチューブをいう。",{"id":5314,"class_notification":5315,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5316,"generic_name":5317,"generic_name_definition":5318,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":276,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},597,"1-0599","35647003","体外固定システム","ケース及び複数のトレイからなる器具をいう。多くのインプラント（ピン、ネジ、ワイヤ等）及び専用手術器具を含む。このシステムは骨折手術、脊椎手術又は矯正手術等、特定の手術用に設計されている。このシステムを維持するため、インプラントを使用した場合は補充する。このシステムの外固定具は、指示された方法に基づき再使用することができる。",{"id":5320,"class_notification":5321,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5322,"code":5323,"generic_name":5324,"generic_name_definition":5325,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":5326,"old_generic_name":5327,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},3942,"3-0705","その他の生体機能補助・代行機器","31068009","尿瘻用ワンピースバッグ","尿路管理における採尿器として用いるプラスチック製の袋で、ストーマを通じて一時的に侵襲する方式のものをいう。","149999005","他に分類されない生体機能補助・代行機器",{"id":5329,"class_notification":5330,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5322,"code":5331,"generic_name":5332,"generic_name_definition":5333,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":5326,"old_generic_name":5327,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},3943,"3-0706","31069009","尿瘻用マルチピースバッグ","尿路管理における採尿器として皮膚に取り付けるプラスチック製の袋で、2つ以上の部品で構成され、ストーマを通じて一時的に侵襲する方式のものをいう。ストーマの基部に尿が滞るのを防止するための逆止弁と、尿を捨てるための排液栓を備えている。",{"id":5335,"class_notification":5336,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5337,"code":5338,"generic_name":5339,"generic_name_definition":5340,"class_classification":3553,"ghtf_rule":5341,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":5342,"old_generic_name":5343,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},4055,"3-0818","歯科診療室用機器","33208000","マッサージピック","手動で歯肉を刺激及びマッサージし、歯周（歯肉）の状態を良好にするために用いる先鋭の口腔衛生器具をいう。","5-①","180299007","その他の歯科診療室用機器",{"id":5345,"class_notification":5346,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4374,"code":5347,"generic_name":5348,"generic_name_definition":5349,"class_classification":3553,"ghtf_rule":5350,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":4379,"old_generic_name":4380,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},4350,"3-1113","70967000","デルマトーム皮膚接合用テープ","各種サイズの両面に粘着剤をコーティーングしたで、デルマトームに貼り付けて皮膚移植組織の採取に用いるテープをいう。本品は単回使用である。","2",{"id":5352,"class_notification":5353,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5258,"code":5354,"generic_name":5355,"generic_name_definition":5356,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":3555,"installation_management":185,"repair_category":5154,"qms_notification":3583,"old_generic_name_code":5357,"old_generic_name":5258,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},4403,"3-1166","18142000","体外型眼瞼ウェイト","上眼瞼の機能を回復するために、瞼に錘りを負わせたり、又は瞼を圧迫する眼科用機器をいう。例えば、上眼瞼に負荷を与える(眼瞼に力を加える)ために上眼瞼の外側に用いる器具がある。一時性麻痺の治療、又は術前の植込み型眼瞼ウェイトの適切なサイズの測定に用いることがある。","249900006",{"id":5359,"class_notification":5360,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5361,"generic_name":5362,"generic_name_definition":5363,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},4450,"3-1213","61448001","手術補助用シート","手術の際に、術野における組織や手術器具等の視認性の向上を目的として一時的に用いる、滅菌済み単回使用のシートである。目盛りを有するものもある。",{"id":5365,"class_notification":5366,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3578,"code":5367,"generic_name":5368,"generic_name_definition":5369,"class_classification":3553,"ghtf_rule":5341,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},4454,"3-1217","71101001","家庭用膣洗浄スポンジ","膣分泌物若しくは精液を吸収し除去するために膣内に挿入して用いる、スポンジ形状のものをいう。",{"id":5371,"class_notification":5372,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3578,"code":5373,"generic_name":5374,"generic_name_definition":5375,"class_classification":3553,"ghtf_rule":3554,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3555,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},4463,"3-1226","45897001","家庭用爪用パッチ","変形、変色等した爪を被覆し、湿潤環境を維持することで外観の改善を図る家庭用の器具をいう。なお、爪真菌等の疾病治療効果を有するものは除く。",{"id":5377,"class_notification":5378,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5379,"generic_name":5380,"generic_name_definition":5381,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":276,"company_count":3680,"market_size_unit":185,"average_price_unit":185,"created_at":207},1130,"1-1132","70435013","縫合部補強材","縫合部の補強に用いる非吸収性の合成材料をいう。自動縫合器と併用されるものを除く。",{"id":5383,"class_notification":5384,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5385,"generic_name":5386,"generic_name_definition":5387,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},1149,"1-1151","71065003","歯科矯正用固定器具","歯科矯正治療において歯の移動のための矯正力を付与するときの固定源として用いるスクリュー及びスクリューに接続するワイヤ、アタッチメント等歯列矯正器材システムの構成品部材からなる器具をいう。歯科矯正治療後は撤去される。単回使用である。",{"id":5389,"class_notification":5390,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5391,"generic_name":5392,"generic_name_definition":5393,"class_classification":197,"ghtf_rule":5254,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3820,"old_generic_name":3821,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},648,"1-0650","36245000","気管食道用スピーチバルブ","外科的に形成した気管食道瘻に挿入する双フランジ付き器具をいう。本品の食道面には直径に沿ってスリットが入っている。喉頭摘出後の発話機能回復訓練に用いる。",{"id":5395,"class_notification":5396,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5397,"generic_name":5398,"generic_name_definition":5399,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},605,"1-0607","38159000","体内固定器具セット","特定の患者のために特別に製造した器具をいう。寸法、設計又は材料が通常のものとは異なる。膝関節を補強するための特別に長い髄内ロッドで近位は大腿骨から遠位は脛骨まで及ぶもの等1個限定の特注器具がその典型であり、現行の規制に従って製造される。本品は、カスタムメイド人工関節セットには該当しない。",{"id":5401,"class_notification":5402,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":5403,"generic_name":5404,"generic_name_definition":5405,"class_classification":3746,"ghtf_rule":4097,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4098,"old_generic_name":4099,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":3739,"company_count":3680,"market_size_unit":185,"average_price_unit":185,"created_at":207},2817,"2-1616","38580000","歯科用精密スライドアタッチメント","雄部を雌部に設けられた精密な溝に嵌合させて取り付ける装置をいう。",{"id":5407,"class_notification":5408,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3549,"code":5409,"generic_name":5410,"generic_name_definition":5411,"class_classification":3746,"ghtf_rule":194,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},3225,"2-2024","71120002","家庭用眼瞼用温熱パック","発熱する特殊な化学物質等を内蔵したもので、活性化することにより発熱したものを目の周囲の皮膚に当てることで、目のかわき、目の疲れ等の症状を緩和する単回使用のパックをいう。本品は、家庭において使用される。",{"id":5413,"class_notification":5414,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5415,"generic_name":5416,"generic_name_definition":5417,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},512,"1-0514","36226000","深部体腔創傷被覆・保護材","筋・骨に至る深い創傷の管理に用いる、天然又は合成素材から成る創傷被覆・保護材をいう。",{"id":5419,"class_notification":5420,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":5322,"code":5421,"generic_name":5422,"generic_name_definition":5423,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5326,"old_generic_name":5327,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":5424,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":3680,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},839,"1-0841","30084000","人工中耳","補聴器の一種で、出力信号を耳小骨等に直接的に振動して伝達する形式のものをいう。","平成27年9月18日",{"id":5426,"class_notification":5427,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5428,"generic_name":5429,"generic_name_definition":5430,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},1080,"1-1082","47023003","単回使用棘間留置器具","腰背部痛及び下肢痛の緩和のため、棘間に留置することにより、腰椎を屈曲位に保ち、伸展位となることを制限するために用いる器具をいう。",{"id":5432,"class_notification":5433,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5434,"generic_name":5435,"generic_name_definition":5436,"class_classification":197,"ghtf_rule":5437,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},1078,"1-1080","47937003","抗菌性カテーテル被覆・保護材","注射針又はカテーテル刺入部に直接貼付してその固定に用いる、粘着性を有するフィルム材などに殺菌剤・抗菌剤を含浸した滅菌済み被覆・保護材をいう。固定保持強化のために不織布等が付加されることもある。","13",{"id":5439,"class_notification":5440,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5441,"generic_name":5442,"generic_name_definition":5443,"class_classification":192,"ghtf_rule":5444,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},189,"1-0189","70440000","コラーゲン使用軟組織注入材","軟組織の増量を目的とする注入用コラーゲンをいう。（部分的に吸収される場合もある。）","8,8-⑤,14",{"id":5446,"class_notification":5447,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5448,"generic_name":5449,"generic_name_definition":5450,"class_classification":192,"ghtf_rule":4402,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},263,"1-0263","35681000","乳頭用補綴材","手術により欠損又は切除した天然乳頭を置換又は修復する器具をいう。本品は「外」表面を有するが、組織に包埋し結合させるためインプラントであると考えられる。",{"id":5452,"class_notification":5453,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5454,"generic_name":5455,"generic_name_definition":5456,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},249,"1-0249","33982004","吸収性骨スペーサ","埋入された人工関節等と骨との間の骨セメント（例えば、ポリメチルメタクリレート(PMMA)）の厚さを確保するために用いる吸収性器具をいう。",{"id":4537,"class_notification":5458,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5459,"generic_name":5460,"generic_name_definition":5461,"class_classification":192,"ghtf_rule":5444,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":3914,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0190","70441000","ヒアルロン酸使用軟組織注入材","軟組織の増量を目的とする注入用ヒアルロン酸をいう。（部分的に吸収される場合もある。）",{"id":5463,"class_notification":5464,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5465,"generic_name":5466,"generic_name_definition":5467,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},591,"1-0593","34163000","人工椎間板","2つの可動椎体間のプレート様構造を置換又は修復する器具をいう。通常、金属、ポリマー、他の人工材料又は生物学的材料、又はこのような物質の組合せを原材料とする。",{"id":5469,"class_notification":5470,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5471,"generic_name":5472,"generic_name_definition":5473,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},251,"1-0251","35671004","吸収性腱鞘スペーサ","組織を分離し、物理的接触を回避するために用いる吸収性器具をいう。これにより、腱を隣接組織に癒着させずに遊離の状態にする。",{"id":3611,"class_notification":5475,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5476,"generic_name":5477,"generic_name_definition":5478,"class_classification":192,"ghtf_rule":5479,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0252","35966004","医薬品組合せ橈骨頭用補綴材","近位橈骨(橈骨小頭)の全置換又は部分置換のために用いる器具をいう。骨セメント固定式のもの又は骨セメントレスのものがある。通常、金属、セラミック、カーボン、ポリマ又はこれらの物質の組合せを原材料とする。部分的に吸収される場合もある。本品は医薬品も含有する。","8,8-⑤,13",{"id":5481,"class_notification":5482,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5483,"generic_name":5484,"generic_name_definition":5485,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},262,"1-0262","35650000","人工髄鞘","神経鞘が機能するように置換又は修復するために用いる器具をいう。",{"id":5487,"class_notification":5488,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5489,"generic_name":5490,"generic_name_definition":5491,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},233,"1-0233","70497000","吸収性体内固定用ボタン","関節再建術時等の固定材として使用するボタン形状を有する吸収性器具をいう。",{"id":5493,"class_notification":5494,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5495,"generic_name":5496,"generic_name_definition":5497,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},234,"1-0234","34170004","吸収性人工椎体","外傷、変形又は変性疾患により1つ又は複数の椎体又は脊椎を欠損した場合に、このうちの1つ又は複数を置換又は修復する器具をいう。吸収性材料製である。",{"id":5499,"class_notification":5500,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5501,"generic_name":5502,"generic_name_definition":5503,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},242,"1-0242","37272004","吸収性脊椎内固定器具","ロッド・プレート・フック・スクリュー(椎弓根スクリューを含む)・コネクタ・ワイヤ・ケーブル等からなる器具をいう。脊椎の固定、支持又はアライメント補正に用いる。通常、金属製、ポリマー製又は他の材料製であり、吸収性の材料を含んでいる。骨折固定、変性又は先天性異常に用いる場合もある。",{"id":5505,"class_notification":5506,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5507,"generic_name":5508,"generic_name_definition":5509,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},244,"1-0244","70502000","吸収性骨固定バンド","骨と軟部組織の締結・縫合、骨とインプラントの固定、骨と骨の固定などに用いる吸収性のワイヤ、ケーブル、バンド等をいう。通常、高分子材料製である。",{"id":5511,"class_notification":5512,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5513,"generic_name":5514,"generic_name_definition":5515,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},245,"1-0245","70505000","吸収性体内固定用ケーブル","骨固定に用いる吸収性ケーブル（撚り線構造）をいう。体内固定器具として使用する。肘頭、膝蓋骨、足関節内果又は大転子等の骨折又は骨切り部を再結合したり、脊椎を固定したりするために、原則として締結器を用いて締結するものである。ケーブルと併用するインプラント等も含む。素材は、通常、高分子材料製である。",{"id":5517,"class_notification":5518,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5519,"generic_name":5520,"generic_name_definition":5521,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},239,"1-0239","35685004","吸収性体内固定用ワイヤ","骨固定に用いる吸収性植込み型器具をいう。例えば、骨固定を補助する締結ワイヤとして、肘頭、脛骨結節又は大転子等を再接合するための8字ループとして、骨ネジ及び骨プレート固定の補強として、足指又は手指を補強(関節固定)するためのキルシュナー鋼線として、様々な用途で用いる。素材は展性があり、長くしたり、コイル状にしたりするものもあれば、硬直・剛性のものもある。",{"id":5523,"class_notification":5524,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5525,"generic_name":5526,"generic_name_definition":5527,"class_classification":192,"ghtf_rule":4945,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},246,"1-0246","11910000","ヒト骨移植片","形成術又は再建術時に補強するか骨形成又は機械的支持を得るために提供者から被移植者に移植する骨をいう。同一患者の別の部位由来のものもあれば、他の患者由来の処理を施したものもある。",{"id":5529,"class_notification":5530,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5531,"generic_name":5532,"generic_name_definition":5533,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},250,"1-0250","34031004","吸収性骨プラグ","骨セメントの通路を限定するために、髄腔を密封する閉塞物として用いる吸収性器具をいう(セメントリストリクタとして使用)。吸収性材料を原料とする。",{"id":5535,"class_notification":5536,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5537,"generic_name":5538,"generic_name_definition":5539,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},258,"1-0258","31744000","心臓内パッチ","心臓の損傷膜の補強又は修復に用いる合成材料製の器具をいう。プレジェットとして用いる場合もある。",{"id":5541,"class_notification":5542,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5543,"generic_name":5544,"generic_name_definition":5545,"class_classification":3553,"ghtf_rule":4783,"specific_maintenance":3555,"installation_management":185,"repair_category":4474,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},3810,"3-0573","43000000","薬剤なし再使用可能な救急キット","非常時の損傷の初期段階治療のための器具や材料を集めた便利な一式をいう。通常、施設、家庭、自動車、救急車サービス、人が多い場所等で使用する。本品に薬物・医薬品は含まれない。本品の再使用可能な品目を適切に洗浄し、消耗品を補充したのちに再使用することができる。",{"id":5547,"class_notification":5548,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5549,"generic_name":5550,"generic_name_definition":5551,"class_classification":3553,"ghtf_rule":3582,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":204,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},3817,"3-0580","36093000","熱傷用ラップ","熱傷センター又は病院へ運ぶ途中の熱傷患者の外傷を覆い、状態を維持するために用いる非滅菌の被覆材をいう。本材は、救急現場での使用を目的とし、熱傷部位を冷し、湿潤を保ち、熱傷の進行を止め、外傷を最小限にし、汚染を防止するために用いる。本材をジェルで覆うことも可能であり、各種（タオルからシーツの大きさ等）のサイズがある。",{"id":5553,"class_notification":5554,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5555,"generic_name":5556,"generic_name_definition":5557,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},256,"1-0256","11912100","人工皮膚","修復、再建又は治療の目的で皮膚欠損の治療に用いるグラフトをいう。",{"id":5559,"class_notification":5560,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5561,"generic_name":5562,"generic_name_definition":5563,"class_classification":192,"ghtf_rule":5564,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},259,"1-0259","33310204","人工耳・鼻・喉用吸収性補綴材","耳鼻咽喉(ENT)の外科手術で、軟部組織の置換又は修復に用いる吸収性器具をいう。コラーゲン又は天然吸収性ゼラチン物質等を原材料とするものもある。","7-④,14",{"id":5566,"class_notification":5567,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5568,"generic_name":5569,"generic_name_definition":5570,"class_classification":192,"ghtf_rule":5571,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},265,"1-0265","36036000","ヒト硬膜移植片","死体硬膜を原材料とする同種移植片をいう。通常、処理及び滅菌を行い、被移植者の硬膜再建又は置換に用いる。硬膜は脊髄の完全性を維持するために不可欠であることから、本品はその完全性を獲得するために用いる場合に有用である。脊髄は損傷又は過度の圧迫から常に保護されていることが重要である。","8-②,14",{"id":5573,"class_notification":5574,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5575,"generic_name":5576,"generic_name_definition":5577,"class_classification":192,"ghtf_rule":4402,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},267,"1-0267","36196000","人工乳房","乳房再建又は豊胸のために用いる植込み型器具をいう。無菌液で膨張させる。",{"id":5579,"class_notification":5580,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5581,"generic_name":5582,"generic_name_definition":5583,"class_classification":192,"ghtf_rule":5584,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},264,"1-0264","35945000","医薬品投与用植込み型避妊具","ゴム製の小型中空ロッド等の器具をいう。レボノルゲストレルのような避妊ホルモン等の避妊薬を充填し、上腕の皮下に埋め込み避妊薬を定常的に全身に放出することを目的としている。","8-⑥",{"id":5586,"class_notification":5587,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5588,"generic_name":5589,"generic_name_definition":5590,"class_classification":197,"ghtf_rule":5215,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},518,"1-0520","70433023","非吸収性抗菌ヘルニア・胸壁・腹壁用補綴材","脆弱化もくは欠損した胸壁、腹壁又はヘルニアの修復に用いる非吸収性合成繊維製の器具をいう。抗菌作用を含んだ物質を有している。",{"id":5592,"class_notification":5593,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5594,"generic_name":5595,"generic_name_definition":5596,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},525,"1-0527","34234003","体内用血管カフ","血管を覆い、更なる損傷を防ぐために静脈瘤等の治療に用いるシース型の器具をいう。通常、高分子材料製である。",{"id":5598,"class_notification":5599,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5600,"generic_name":5601,"generic_name_definition":5602,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},523,"1-0525","32814000","眼科手術用クリップ","治癒を促進するか眼の小血管からの出血を予防するために、永久的又は一時的に植え込むために用いる眼科用留め金具をいう。例えば、タンタルなどの可鍛金属を用いることがある。",{"id":5604,"class_notification":5605,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5606,"generic_name":5607,"generic_name_definition":5608,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},533,"1-0535","33616000","親水性ビーズ","多孔性球状ポリマであり、架橋剤のエピクロヒドリン等で糖鎖がデキストラノマ鎖等の網目構造を呈しているものをいう。下腿潰瘍や重症熱傷等の滲出性皮膚欠損部位に適用され、肉芽形成促進を図る。",{"id":5610,"class_notification":5611,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5612,"generic_name":5613,"generic_name_definition":5614,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},527,"1-0529","36237100","涙点プラグ","涙点開口部に挿入して涙の流出を防ぐ器具をいう。例えば、ドライアイ患者に用いることがある。",{"id":5616,"class_notification":5617,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5618,"generic_name":5619,"generic_name_definition":5620,"class_classification":197,"ghtf_rule":5621,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},528,"1-0530","36237200","コラーゲン使用涙点プラグ","涙点開口部に挿入して涙の流出を防ぐコラーゲン使用器具をいう。例えば、ドライアイ患者に用いることがある。","8,14",{"id":5623,"class_notification":5624,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5625,"generic_name":5626,"generic_name_definition":5627,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},531,"1-0533","70442000","外眼眼窩インプラント","外傷等により網膜剥離を起こした眼球を圧迫するために使用する合成材料製器具をいう。",{"id":5629,"class_notification":5630,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5631,"generic_name":5632,"generic_name_definition":5633,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},534,"1-0536","17649000","胃形成術用バンド","減量のため摂取する食物の量を減らす目的で、出口の狭い小嚢を作製するために体内で胃上部周囲に設置したベルト又はストリップをいう。外科的に胃に取り付けるものや調節可能なものがある。",{"id":5635,"class_notification":5636,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5637,"generic_name":5638,"generic_name_definition":5639,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4554,"old_generic_name":4555,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},581,"1-0583","70495000","人工肘関節尺骨コンポーネント","近位尺骨間接表面の一部又は全体を補強又は置換する金属又は高分子材料ポリマー製等の尺骨コンポーネント器具をいう。セメント固定式のもの又はセメントレスのものがある。拘束式又は非拘束式人工肘関節の一部をなすものもある。",{"id":5641,"class_notification":5642,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5643,"generic_name":5644,"generic_name_definition":5645,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},188,"1-0188","70439000","ブタ歯胚組織使用歯周組織再生用材料","歯周組織の再生を図る目的で被覆、塗布、充填等によって口腔内の患部に適用される材料で、ブタ歯胚組織由来成分を含有するものをいう。",{"id":5647,"class_notification":5648,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5649,"generic_name":5650,"generic_name_definition":5651,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},584,"1-0586","16077003","体内固定用ボルト","牽引装置など類似の装置に安全性を付与するために、骨に挿入する非吸収性器具をいう。ナットで固定し、ワッシャーを備えたものもある。金属製のものもあればポリマー製のものもある。",{"id":5653,"class_notification":5654,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5655,"generic_name":5656,"generic_name_definition":5657,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},630,"1-0632","35678000","人工頬骨","頬骨の置換又は修復に用いる器具をいう。通常、金属製で、ポリマ製のものもある。",{"id":5659,"class_notification":5660,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5661,"generic_name":5662,"generic_name_definition":5663,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":3680,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},615,"1-0617","32837000","全人工足関節","足関節の主要関節面を置換するために用いる人工関節をいう。通常、金属、セラミック、カーボン、ポリマー又はこのような物質の組合せを原材料とする。非拘束式、拘束式又は半拘束式のものがある。セメント固定式のもの又はセメントレスのものがある。",{"id":4757,"class_notification":5665,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5666,"generic_name":5667,"generic_name_definition":5668,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0634","35727000","人工橈骨手根関節橈骨・尺骨コンポーネント","手根骨支持面を置換し、遠位橈骨及び尺骨と手根骨との関節支持面を置換する人工関節コンポーネントをいう。通常、金属、セラミック、カーボン又はポリマ又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",{"id":5670,"class_notification":5671,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5672,"generic_name":5673,"generic_name_definition":5674,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},633,"1-0635","35966003","橈骨頭用補綴材","近位橈骨(橈骨小頭)の全置換又は部分置換のために用いる器具をいう。骨セメント固定式のもの又は骨セメントレスのものがある。通常、金属、セラミック、カーボン、ポリマ又はこれらの物質の組合せを原材料とする。",{"id":5676,"class_notification":5677,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5678,"generic_name":5679,"generic_name_definition":5680,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},634,"1-0636","36042000","全人工側頭下顎関節","全側頭下顎関節の再建に用いる植込み型人工関節をいう。通常、金属及びポリマー等の人工材料製である。",{"id":410,"class_notification":5682,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5683,"generic_name":5684,"generic_name_definition":5685,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0601","35943000","人工顎関節","顎関節の下顎骨部の再建に用いる植込み型人工関節をいう。通常、金属又はポリマー等の人工材料で作られる。",{"id":5687,"class_notification":5688,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5689,"generic_name":5690,"generic_name_definition":5691,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},620,"1-0622","33705000","全人工手関節","手関節の関節表面の置換又は代用のために用いる人工関節をいう。非拘束式、拘束式又は半拘束式のものがある。通常、金属、セラミック、カーボン又はポリマ又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",{"id":5693,"class_notification":5694,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5695,"generic_name":5696,"generic_name_definition":5697,"class_classification":197,"ghtf_rule":5621,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},631,"1-0633","35690000","局所人工耳小骨","中耳等の小骨の置換のために用いる生物学的器具又は人工合成器具をいう。",{"id":5699,"class_notification":5700,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5701,"generic_name":5702,"generic_name_definition":5703,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},1148,"1-1150","58882003","植込み型前立腺組織牽引システム","尿道の開存性を維持するため、前立腺組織を牽引するインプラントを経尿道的に留置するシステムをいう。縫合糸及び金属等からなるインプラントと、それを送達するためのデリバリーデバイス等から構成される。",{"id":5705,"class_notification":5706,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5707,"generic_name":5708,"generic_name_definition":5709,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},514,"1-0516","16048003","手術用メッシュ","損傷又は変性疾患後に軟組織又は硬組織を被覆、支持するために用いる非吸収性器具をいう。金属製のものもあれば高分子材料製のものある。",{"id":5711,"class_notification":5712,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5713,"generic_name":5714,"generic_name_definition":5715,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},617,"1-0619","33168000","人工上顎骨","上顎骨の修復又は置換に用いる器具をいう。通常、金属製であるが、ポリマ製のものもある。",{"id":5717,"class_notification":5718,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5719,"generic_name":5720,"generic_name_definition":5721,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},674,"1-0676","35272000","筋肉用補綴材","補綴、治療又は実験の目的で、筋肉組織を置換するために体内に一部又は全体を挿入する器具をいう。",{"id":5723,"class_notification":5724,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5725,"generic_name":5726,"generic_name_definition":5727,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},675,"1-0677","35277000","人工精巣","睾丸の形状をした器具をいう。睾丸の美容的外見を与えるために陰嚢に植え込む。審美的役割を果たし、心因性続発症を予防する。すべてがシリコーンゴム等のポリマーで作られているものもあれば、シリコーンオイルを充填したシリコーン被膜で作られているものもある。金属材料製のものもある。",{"id":5729,"class_notification":5730,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5731,"generic_name":5732,"generic_name_definition":5733,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},678,"1-0680","35280000","尿道括約筋用補綴材","失禁に適用される体内器具をいう。天然尿道括約筋の支持又は置換を目的としている。通常、尿道を囲むシングルカフ又はダブルカフ、生理食塩液等の圧媒液(放射線不透明化剤を含有するものもある)を含むリザーバ及び手動ポンプからなる。主に非吸収性ポリマ材料から作られる。",{"id":5735,"class_notification":5736,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":188,"code":5737,"generic_name":5738,"generic_name_definition":5739,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":195,"old_generic_name":196,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},1042,"1-1044","42350000","歯科用粘膜内インプラント材","口腔の軟組織に埋植する歯科用インプラントをいう。",{"id":5741,"class_notification":5742,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5743,"generic_name":5744,"generic_name_definition":5745,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1145,"1-1147","47257004","ヒト脱灰骨基質使用吸収性骨再生用材料","骨組織の再生を図る目的で、被覆、塗布、充填等によって患部に適用されるヒト同種骨由来の脱灰骨基質使用吸収性材料をいう。",{"id":5747,"class_notification":5748,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5749,"generic_name":5750,"generic_name_definition":5751,"class_classification":3553,"ghtf_rule":4845,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},3820,"3-0583","70445000","創傷深度測定器","非侵襲のプローブからなり、体表面に短時間当て、創傷やポケットの大きさ(幅）や深さ（正常皮膚と創との差異）を測定する。損傷皮膚に接触する場合には滅菌済みで単回使用とする。",{"id":5753,"class_notification":5754,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5755,"generic_name":5756,"generic_name_definition":5757,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},629,"1-0631","35677000","人工眼窩縁","眼窩底又は眼窩縁の再建に用いる器具をいう。通常、ステンレス、チタン又はチタン合金製である。他の物質を原材料とするものもある。",{"id":1112,"class_notification":5759,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5760,"generic_name":5761,"generic_name_definition":5762,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":3680,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-1152","47406003","腹部開放創用ドレッシングキット","腹部開放創部を覆い、管理された陰圧をかけることにより、外界からの腹部臓器の保護、効率的なドレナージ、炎症の抑制、浮腫の軽減等を図り、早期の腹膜閉鎖を可能とするためのドレッシングキットをいう。通常、フォーム、ドレープ、チュービングセット及び保護レイヤで構成される。",{"id":5764,"class_notification":5765,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5766,"generic_name":5767,"generic_name_definition":5768,"class_classification":192,"ghtf_rule":4162,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":5769},28042,"1-1215","71141004","吸収性軟骨再生用材料","軟骨組織の再生を図る目的で、被覆、塗布、充填等によって患部に適用される吸収性材料をいう。生物学的効果を意図したり、医薬品を含有したり、生物由来原材料を使用したりすることがある。","2025-08-16T03:36:31.037267+00:00",{"id":5771,"class_notification":5772,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5773,"generic_name":5774,"generic_name_definition":5775,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":286,"company_count":286,"market_size_unit":185,"average_price_unit":185,"created_at":207},637,"1-0639","38158000","人工関節セット","特定の患者のために特別に製造した人工関節器具をいう。寸法、設計又は材料が通常のものとは異なる。",{"id":5777,"class_notification":5778,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5779,"generic_name":5780,"generic_name_definition":5781,"class_classification":197,"ghtf_rule":5621,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":598,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1121,"1-1123","61127003","ヘパリン使用眼内ドレーン","眼内に植え込み、眼圧上昇を緩和するために用いるヘパリン使用人工ドレーンをいう。",{"id":5783,"class_notification":5784,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5785,"generic_name":5786,"generic_name_definition":5787,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1190,"1-1192","46647003","体内固定用肋骨髄内釘","金属製等のロッドをいう。肋骨の髄内に挿入し、骨折又は病的状態にある骨の両端を正しい位置に保持するための固定器具としての役割を果たす。",{"id":5789,"class_notification":5790,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5791,"generic_name":5792,"generic_name_definition":5793,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1192,"1-1194","44854003","体内固定用腓骨髄内釘","金属製等のロッドをいう。腓骨の髄内に挿入し、骨折又は病的状態にある骨の両端を正しい位置に保持するための固定器具としての役割を果たす。",{"id":5795,"class_notification":5796,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5797,"generic_name":5798,"generic_name_definition":5799,"class_classification":197,"ghtf_rule":5800,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},1201,"1-1203","47917003","非吸収性局所止血材","止血のために、皮膚創傷又は消化管内に適用する、非吸収性の素材からなる器具をいう。","7-②,8",{"id":5802,"class_notification":5803,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5804,"generic_name":5805,"generic_name_definition":5806,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":3583,"old_generic_name_code":194,"old_generic_name":194,"old_class_classification":194,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":5769},28040,"1-1213","71139003","非吸収性ヘルニア・胸壁・腹壁用補綴材固定用接着材","脆弱化もしくは欠損した胸壁、腹壁又はヘルニアの修復に用いるシート等を組織に固定するための非吸収性の接着材をいう。接着材を送達させるためのアプリケータを備えるものもある。",{"id":5808,"class_notification":5809,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5810,"generic_name":5811,"generic_name_definition":5812,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4366,"old_generic_name":4367,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},501,"1-0503","37298003","二次治癒生理食塩液含有創傷被覆・保護材","創傷の生物学的洗浄の促進及び自己融解デブリドマンの補助を目的とする､生理食塩液を含有する二次治癒創傷被覆・保護材をいう。",{"id":5814,"class_notification":5815,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5816,"generic_name":5208,"generic_name_definition":5817,"class_classification":197,"ghtf_rule":5818,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5207,"old_generic_name":5208,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},506,"1-0508","34615100","生体工学的材料から成る、創傷を保護し治癒に伴い皮膚内に吸収される創傷被覆・保護材をいう。","4-①,14",{"id":5820,"class_notification":5821,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5822,"generic_name":5823,"generic_name_definition":5824,"class_classification":197,"ghtf_rule":5818,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5207,"old_generic_name":5208,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},507,"1-0509","34615200","コラーゲン使用吸収性創傷被覆・保護材","生体工学的材料から成る、創傷を保護し治癒に伴い皮膚内に吸収されるコラーゲン使用創傷被覆・保護材をいう。",{"id":5826,"class_notification":5827,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5828,"generic_name":5829,"generic_name_definition":5830,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},509,"1-0511","15319000","植皮部・採皮部創傷被覆・保護材","熱傷､植皮部及び採皮部等の各種創傷の被覆及び保護を目的とする、マイラー又は他素材から成る非吸収性の非固着性シートをいう。",{"id":5832,"class_notification":5833,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5834,"generic_name":5835,"generic_name_definition":5836,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},510,"1-0512","34059000","創傷被覆・保護材キット","創傷を被覆するために必要な各種器具、被覆・保護材、医薬品等を予め包装したキット、トレー又はセットをいう。",{"id":5838,"class_notification":5839,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5840,"generic_name":5841,"generic_name_definition":5842,"class_classification":197,"ghtf_rule":5818,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},511,"1-0513","34083000","相互作用性創傷被覆・保護材","直接または間接的に身体組織と相互作用することにより創傷又は熱傷の治癒を積極的に促進することを目的とする、合成又は天然素材から成る滅菌済創傷被覆・保護材をいう。",{"id":5844,"class_notification":5845,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5846,"generic_name":5847,"generic_name_definition":5848,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},516,"1-0518","36111003","非吸収性バンド型胃形成術用補綴材","再建・機能のために胃の一部に植え込む非吸収性の器具をいう。本品は特定の位置に植え込むパーツからなる。",{"id":5850,"class_notification":5851,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5852,"generic_name":5853,"generic_name_definition":5854,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3538,"old_generic_name":3539,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2368,"2-1165","35487000","整形外科用ローテータ","医療目的で、ギプス、装具又は移植器具の使用を支持、保護又は支援するために用いる移植器具又は装具の付属品をいう。",{"id":4240,"class_notification":5856,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5857,"generic_name":5858,"generic_name_definition":5859,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0521","70435000","非吸収性ステープルライン補強材料","組織欠損部、縫合部又は接合部を補強するために、自動縫合器と併用され、ポリテトラフルオロエチレン等の合成非吸収性素材からなるものをいう。",{"id":5861,"class_notification":5862,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5863,"generic_name":5864,"generic_name_definition":5865,"class_classification":197,"ghtf_rule":5866,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},521,"1-0523","11322203","コラーゲン使用熱傷被覆・保護材","熱傷皮膚を被覆及び保護し、熱傷部位の滲出液を吸収するために用いる幅広のコラーゲン使用層状ガーゼパッドをいう。","4,14",{"id":5868,"class_notification":5869,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5870,"generic_name":5871,"generic_name_definition":5872,"class_classification":197,"ghtf_rule":5254,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},522,"1-0524","16073000","瞼球癒着防止リング","眼瞼の眼球への癒着を防止するために用いる機器をいう。例えば、緑内障などの場合、創面を分離させておくために用いることがある。高分子材料製のものもあれば、単純な粘膜グラフトのものもある。",{"id":5874,"class_notification":5875,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5876,"generic_name":5877,"generic_name_definition":5878,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},524,"1-0526","33385003","神経用カフ","神経を包み込み、この神経の修復を促進するために用いるシリコーンゴム製のシース等の器具をいう。瘢痕組織の上皮増殖防止のほか、腫瘍形成を予防するために神経端を覆う等の目的で用いる。",{"id":5880,"class_notification":5881,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5882,"generic_name":5883,"generic_name_definition":5884,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2272,"2-1069","70449000","植皮用皮膚剥離器","皮膚移植の目的で採皮のために用いる手術器具をいう。手動式又は動力式を含む。",{"id":5886,"class_notification":5887,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5888,"generic_name":5889,"generic_name_definition":5890,"class_classification":3746,"ghtf_rule":3747,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4366,"old_generic_name":4367,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2248,"2-1045","37298002","局所管理生理食塩液含有創傷被覆・保護材","創傷の生物学的洗浄の促進及び自己融解デブリドマンの補助を目的とする､高張生理食塩液を含有する局所管理創傷被覆・保護材をいう。",{"id":5892,"class_notification":5893,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":5894,"generic_name":5895,"generic_name_definition":5896,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2254,"2-1051","44047000","薬剤なし単回使用救急キット","非常時の損傷の初期段階治療のための器具や材料を集めた便利な一式をいう。通常、家庭、自動車、救急車サービス、人が多い場所等で使用する。本品に薬物・医薬品は含まれない。本品は単回使用である。",{"id":5898,"class_notification":5899,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":4030,"code":5900,"generic_name":5901,"generic_name_definition":5902,"class_classification":3746,"ghtf_rule":4683,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4261,"old_generic_name":4262,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},2270,"2-1067","37547000","再使用可能な外科処置キット","一般外科処置に必要な種々の器具、創傷被覆・保護材及び医薬品すべてを含むパッケージキット、セット又はトレイをいう。本品は適切な洗浄後に再使用することができる。",{"id":5904,"class_notification":5905,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5906,"generic_name":5907,"generic_name_definition":5908,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},613,"1-0615","44267000","関節全置換術用セメントスペーサ","通常全関節の外科的修復後に骨と骨との接触及び軟組織の収縮を回避するため、関節腔に一時的に設置するセメント製の器具をいう。",{"id":5910,"class_notification":5911,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5912,"generic_name":5913,"generic_name_definition":5914,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},614,"1-0616","16082000","人工骨キャップ","若年切断患者の骨過成長を抑制するために上腕骨又は脛骨などの骨の切断端を覆うために用いる植込み型器具をいう。",{"id":5916,"class_notification":5917,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5918,"generic_name":5919,"generic_name_definition":5920,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},616,"1-0618","32869003","非吸収性人工腱","欠損又は損傷した腱の機能を回復するために置換又は修復することを目的とした植込み型器具をいう。本品は非吸収性材料製である。",{"id":5922,"class_notification":5923,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5924,"generic_name":5925,"generic_name_definition":5926,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},623,"1-0625","34108000","人工足関節距骨コンポーネント","関節面の置換又は修復のために距骨に取り付ける人工足関節コンポーネントをいう。通常、金属、セラミック、カーボン、ポリマ又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",{"id":5928,"class_notification":5929,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5930,"generic_name":5931,"generic_name_definition":5932,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},624,"1-0626","35261000","人工下顎骨","下顎の変形の矯正又は容貌の改善のために下顎の軟部組織に植え込む器具をいう。通常、ポリマ製である。",{"id":5934,"class_notification":5935,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5936,"generic_name":5937,"generic_name_definition":5938,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},625,"1-0627","35662000","人工足関節脛骨コンポーネント","関節面の置換又は修復のために脛骨遠位に取り付ける人工足関節コンポーネントをいう。通常、金属、セラミック、カーボン、ポリマ又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",{"id":5940,"class_notification":5941,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5942,"generic_name":5943,"generic_name_definition":5944,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},626,"1-0628","35663000","人工手関節手根骨コンポーネント","手根骨支持面を置換し、人工橈骨・尺骨との関節を造る人工関節コンポーネントをいう。通常、金属、セラミック、カーボン、ポリマ又はこのような物質の組合せを原材料とする。セメント固定式のもの又はセメントレスのものがある。",{"id":5946,"class_notification":5947,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5948,"generic_name":5949,"generic_name_definition":5950,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},628,"1-0630","35674000","人工全耳小骨","聴力の矯正又は回復のために耳小骨の置換を目的とした器具又は複数の器具から成るシステムをいう。通常、生物学的材料又は合成材料製である。",{"id":5952,"class_notification":5953,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5954,"generic_name":5955,"generic_name_definition":5956,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},635,"1-0637","36260000","人工側頭下顎関節円板","側頭下顎関節の下顎頭と関節窩との間に接点を形成することを目的とした中間挿入用インプラント又は関節円板をいう。通常、金属及びポリマ等の人工材料製である。",{"id":5958,"class_notification":5959,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5960,"generic_name":5229,"generic_name_definition":5961,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":5228,"old_generic_name":5229,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},646,"1-0648","34410000","中耳の鼓膜の修復又は置換のために用いる器具をいう。合成材料製のものもある。",{"id":5963,"class_notification":5964,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5965,"generic_name":5966,"generic_name_definition":5967,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},649,"1-0651","17876000","液状組織再生材料","美容又は再建の目的で空隙を埋めるために注射又は注入する合成の液状物質をいう。",{"id":5969,"class_notification":5970,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5971,"generic_name":5972,"generic_name_definition":5973,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},650,"1-0652","33643000","中耳腔換気用半透膜チューブ","中耳の換気又はドレナージのほか、中耳腔への液体流入を防ぐために植え込む小型の中空円筒型器具をいう。鼓膜から挿入し、外耳と中耳との間を空気が自由に行き交うようにする。チューブ部分はシリコーンエラストマー製又は多孔性ポリエチレン製で、膜部分はポリテトラフルオロエチレン製である。",{"id":5975,"class_notification":5976,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5977,"generic_name":5978,"generic_name_definition":5979,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},653,"1-0655","18074000","植込み型眼瞼ウェイト","上眼瞼の機能回復のため、瞼に錘りを負わせたり、又は瞼を圧迫する眼科用機器をいう。上眼瞼内に植え込むことを目的としている。",{"id":5981,"class_notification":5982,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5983,"generic_name":5984,"generic_name_definition":5985,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},655,"1-0657","31931000","リンパ管用チューブ補綴材","内リンパ管の一部の修復又は置換に用いる器具をいう。物質を一方向に送るための弁を備えたものもある。",{"id":5987,"class_notification":5988,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5989,"generic_name":5990,"generic_name_definition":5991,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},656,"1-0658","31934000","中耳用植込みモールド","鼓膜修復時に埋め込んで中耳腔を再建することを目的としたモールドとしての役割を果たす器具をいう。中耳に空気を十分に満たした腔を維持し、中耳腔粘膜の再生を促進することができる。ポリアミド、ポリテトラフルオロエチレン、シリコーンエラストマー又はポリエチレン製である。",{"id":3652,"class_notification":5993,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":5994,"generic_name":5995,"generic_name_definition":5996,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0659","31994000","機械式・水圧式植込み失禁器具","尿道を閉塞するために連続的又は間欠的に圧力を加えることにより尿失禁を治療するために用いる埋め込み型器具をいう。完全植込み器具は静圧力パッドからなるものもあれば、腹部に埋め込んだ放射線不透過性液の容器及び皮膚表面下に埋め込み、チューブにより調節式圧力パッド又は尿道を囲むカフに接続した手動ポンプ及びバルブを備えたシステムからなるものもある。放射線不透過性液を必要に応じて容器から送り込み、パッド又はカフを膨張させて尿道を圧迫する。",{"id":5998,"class_notification":5999,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6000,"generic_name":6001,"generic_name_definition":6002,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},658,"1-0660","31995003","輸精管用補綴材","副睾丸から尿道に精子を輸送する管の損傷部又は閉塞部の修復に用いる器具をいう。短期的使用は含まない。",{"id":6004,"class_notification":6005,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6006,"generic_name":6007,"generic_name_definition":6008,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},660,"1-0662","33310103","人工耳・鼻・喉用補綴材","耳鼻咽喉(ENT)の外科手術で、軟部組織の置換又は修復に用いる非吸収性器具をいう。本品は多孔性ポリエチレン、シリコーンエラストマー、ポリウレタン又はポリアミド等のポリマー製である。",{"id":6010,"class_notification":6011,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6012,"generic_name":6013,"generic_name_definition":6014,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4205,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},661,"1-0663","33473103","体内用合成・炭素繊維補綴材","炭素繊維で補強したポリテトラフルオロエチレン(PTFE)から成り、非吸収性インプラント用複合材料を作製するためのものをいう。美容外科で顎、鼻又は眼周囲の骨及び組織の形状の修復に用いることができる。",{"id":6016,"class_notification":6017,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6018,"generic_name":6019,"generic_name_definition":6020,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},662,"1-0664","33806000","腸管スプリンティングチューブ補綴材","腸管の一部を原位置に保持するか又は腸管の損傷部を原位置に保持し、保護するために用いる硬性又は軟性の器具をいう。",{"id":6022,"class_notification":6023,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6024,"generic_name":6025,"generic_name_definition":6026,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},665,"1-0667","34214100","体内用失禁補綴材","排便又は排尿などの排泄機能が制御不能の場合に矯正又は制御に用いる植込み型器具をいう。",{"id":6028,"class_notification":6029,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6030,"generic_name":6031,"generic_name_definition":6032,"class_classification":197,"ghtf_rule":5621,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},666,"1-0668","34214200","コラーゲン使用体内用失禁補綴材","排便又は排尿などの排泄機能が制御不能の場合に矯正又は制御に用いるコラーゲンを用いた植込み型器具をいう。膀胱尿管逆流症の治療又はスキンテストを目的として使用される場合もある。",{"id":6034,"class_notification":6035,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6036,"generic_name":6037,"generic_name_definition":6038,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},667,"1-0669","35258000","胆管用補綴材","機能回復を目的として、胆嚢から胆汁を運ぶ管の置換又は修復のために用いる器具をいう。",{"id":6040,"class_notification":6041,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6042,"generic_name":6043,"generic_name_definition":6044,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},668,"1-0670","35259000","膀胱用メッシュ補綴材","膀胱又は他の置換組織の壁を支持するために用いる器具をいう。高分子材料製で解剖学的構造に適合するように蝶形のものもあればV字型のものもある。",{"id":6046,"class_notification":6047,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6048,"generic_name":6049,"generic_name_definition":6050,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},669,"1-0671","35260000","子宮頸管縫縮用補綴材","子宮頸部の支持及び機能回復のために用いる器具をいう。",{"id":6052,"class_notification":6053,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6054,"generic_name":6055,"generic_name_definition":6056,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},670,"1-0672","35262000","耳用補綴材","通常、美容上の理由により、外耳を再建する組織に埋め込むことを目的とした器具をいう。聴覚機構の補強に用いる場合もある。外部コンポーネントは、通常、高分子材料製である。内部コンポーネントにはネジで固定するものもある。",{"id":6058,"class_notification":6059,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6060,"generic_name":6061,"generic_name_definition":6062,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},671,"1-0673","35263000","人工食道用補綴材","食道が機能するように置換又は修復するために挿入する管状器具をいう。",{"id":6064,"class_notification":6065,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6066,"generic_name":6067,"generic_name_definition":6068,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},672,"1-0674","35264000","卵管用チューブ補綴材","卵管の機能を置換又は修復する器具をいう。",{"id":6070,"class_notification":6071,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6072,"generic_name":6073,"generic_name_definition":6074,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},673,"1-0675","35268000","喉頭用補綴材","喉頭機能の置換・修復、又は喉頭の開存性維持のために用いる器具をいう。ステンレス、ポリマー等を原材料とする。",{"id":6076,"class_notification":6077,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6078,"generic_name":6079,"generic_name_definition":6080,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},676,"1-0678","35278000","気管支用補綴材","機能回復のために気管・気管支全体又は一部を置換するために用いる器具をいう。",{"id":6082,"class_notification":6083,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6084,"generic_name":6085,"generic_name_definition":6086,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},677,"1-0679","35279000","尿道用チューブ補綴材","尿道の置換又は修復のために用いる器具をいう。",{"id":6088,"class_notification":6089,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6090,"generic_name":6091,"generic_name_definition":6092,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},679,"1-0681","35458000","気管用補綴材","気道再建術で天然気管を置換するために用いる管状器具をいう。",{"id":6094,"class_notification":6095,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6096,"generic_name":6097,"generic_name_definition":6098,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},680,"1-0682","35512000","耳管用チューブ補綴材","中耳から咽頭までの耳管を置換又は修復するために用いる器具をいう。",{"id":6100,"class_notification":6101,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6102,"generic_name":6103,"generic_name_definition":6104,"class_classification":197,"ghtf_rule":5254,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},681,"1-0683","35695000","消化管用逆流防止補綴材","重度の胃食道逆流症の治療に用いる器具をいう。",{"id":6106,"class_notification":6107,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6108,"generic_name":6109,"generic_name_definition":6110,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},686,"1-0688","42525000","人工角膜","角膜の置換及び視覚の回復のために用いる機器をいう。",{"id":6112,"class_notification":6113,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6114,"generic_name":6115,"generic_name_definition":6116,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},687,"1-0689","42526000","眼弁補綴材","ヒト眼の弁の置換を目的とした膜様の人工器具をいう。",{"id":6118,"class_notification":6119,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6120,"generic_name":6121,"generic_name_definition":6122,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},689,"1-0691","70512000","非中心循環系塞栓形成インプラントキット","非中心循環系の動脈又は血管に永続的又は一時的な塞栓を形成する（血流を停止させる）塞栓形成インプラントを植え込むために組み合わせて用いる器具及び用品を集めたものをいう。通常、塞栓形成インプラント、挿入器、専用注射筒からなり、手術に必要な他の用品が含まれる場合もある。本品は単回使用である。",{"id":6124,"class_notification":6125,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6126,"generic_name":6127,"generic_name_definition":6128,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3568,"old_generic_name":3569,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},571,"1-0573","32836000","片側置換型脛骨用人工膝関節","近位脛骨の表面及び欠損を置換する人工関節をいう。大腿顆のみと関節をなすように設計されている。一般に半関節又は人工脛骨プラトーとして知られている。",{"id":6130,"class_notification":6131,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":6132,"code":6133,"generic_name":6134,"generic_name_definition":6135,"class_classification":192,"ghtf_rule":5050,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":6136,"old_generic_name":6137,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},166,"1-0166","結さつ（紮）・縫合用器械器具","34606020","吸収性体内用結さつクリップ","吸収性の植込み型器具で、導管又は血管などの体内組織に適用し、この組織からのリークを防いだり、止めたりするものをいう。カートリッジに装填されることがある。カートリッジやアプライヤには、組織の切断のためにナイフが内蔵されているものもある。アプライヤにセットされた状態で供給される場合もある。","100899025","吸収性縫合用クリップ又はクレンメ",{"id":6139,"class_notification":6140,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6141,"generic_name":6142,"generic_name_definition":6143,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4110,"old_generic_name":4111,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},627,"1-0629","35671003","腱鞘スペーサ","組織を分離し、物理的接触を回避するために用いる非吸収性器具をいう。これにより、腱を隣接組織に癒着させずに遊離の状態にする。",{"id":6145,"class_notification":6146,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6147,"generic_name":6148,"generic_name_definition":6149,"class_classification":192,"ghtf_rule":193,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},170,"1-0170","16048004","手術用吸収性メッシュ","損傷又は変性疾患後に軟組織又は硬組織を被覆、支持するために用いる吸収性器具をいう。ポリグリコール酸等の生分解性物質を原材料とする場合、短期インプラントとして用いることができる。",{"id":6151,"class_notification":6152,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6153,"generic_name":6154,"generic_name_definition":6155,"class_classification":192,"ghtf_rule":3672,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3832,"old_generic_name":3833,"old_class_classification":3834,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},172,"1-0172","36111004","吸収性バンド型胃形成術用補綴材","再建・機能のために胃の一部に植え込む吸収性の器具をいう。本品は特定の位置に植え込むパーツからなる。",{"id":6157,"class_notification":6158,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6159,"generic_name":6160,"generic_name_definition":6161,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},683,"1-0685","36250000","人工陰茎","勃起陰萎に適用される体内器具をいう。陰茎の膨張性及び硬直性を得るために用いる。本品は油圧式で、シリコーンゴム又は他のポリマーを原材料とする。陰茎に植え込み、腹部に植え込む生理食塩液(放射線不透明化剤を添加したものもある)等の液体を含むリザーバ及び陰嚢皮下に植え込む手動式ポンプに接続した1つ又は複数の膨張式のシリンダからなる。",{"id":6163,"class_notification":6164,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3519,"code":6165,"generic_name":6166,"generic_name_definition":6167,"class_classification":197,"ghtf_rule":3523,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3881,"old_generic_name":3882,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":6168,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":203,"company_count":598,"market_size_unit":185,"average_price_unit":185,"created_at":207},690,"1-0692","70513000","網膜復位用人工補綴材","剥離した網膜を脈絡膜上に復位させるため、眼球を局部的に変形・固定させるための眼科用滅菌済みインプラント機器をいう。","平成28年7月28日",{"id":6170,"class_notification":6171,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6172,"generic_name":6173,"generic_name_definition":6174,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4877,"old_generic_name":4878,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},181,"1-0181","34164200","コラーゲン使用軟組織接合用接着剤","傷の治癒を促進させるために傷口の接着に用いる生体適合性のコラーゲン使用接着剤をいい、アクリル酸塩又は他の合成物質より成る。",{"id":3654,"class_notification":6176,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6177,"generic_name":6178,"generic_name_definition":6179,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":926,"last_updated_date":4403,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0182","33385004","中枢神経用カフ","中枢神経を包み込み、この神経の修復を促進するために用いるシリコーンゴム製のシース等の器具で、瘢痕組織の上皮増殖防止のほか、腫瘍形成を予防するために神経端を覆う等の目的で用いる。",{"id":6181,"class_notification":6182,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6183,"generic_name":6184,"generic_name_definition":6185,"class_classification":192,"ghtf_rule":3964,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3673,"old_generic_name":3674,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},184,"1-0184","34234004","中心循環系血管用カフ","中心循環系血管を覆い、更なる損傷を防ぐために静脈瘤等の治療に用いるシース型の器具をいう。通常、高分子材料製である。",{"id":4704,"class_notification":6187,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6188,"generic_name":6189,"generic_name_definition":6190,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4877,"old_generic_name":4878,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0178","33492204","アルブミン使用接着剤","1つの組織の表面を他の組織表面又は材料に固着させるために用いる汎用のアルブミン含有試薬をいう。",{"id":6192,"class_notification":6193,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6194,"generic_name":6195,"generic_name_definition":6196,"class_classification":197,"ghtf_rule":4034,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":4280,"old_generic_name":4281,"old_class_classification":194,"old_repair_category":3675,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":4036,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":185,"company_count":185,"market_size_unit":185,"average_price_unit":185,"created_at":207},513,"1-0515","37275000","加温・密封性創傷被覆・保護材","環境中の空気及びバクテリアへの暴露を防ぐために創傷を密閉する創傷被覆・保護材をいう。創傷の治癒を促進するために本材を加温する。",{"id":382,"class_notification":6198,"specific_maintenance_notification":185,"installation_management_notification":185,"category_code":186,"category_name":187,"subcategory_name":3644,"code":6199,"generic_name":6200,"generic_name_definition":6201,"class_classification":192,"ghtf_rule":3998,"specific_maintenance":194,"installation_management":185,"repair_category":194,"qms_notification":194,"old_generic_name_code":3722,"old_generic_name":3720,"old_class_classification":197,"old_repair_category":194,"revision_count":185,"last_updated_date":185,"data_exist":4036,"product_exist":198,"market_size":185,"growth_ratio":185,"average_price":185,"domestic_ratio":185,"product_count":926,"company_count":926,"market_size_unit":185,"average_price_unit":185,"created_at":207},"1-0177","35895300","ゼラチン使用吸収性局所止血材","止血のために、外科切開口、皮膚創傷又は内部構造に適用する、身体に吸収される素材からなるゼラチン使用器具をいう。接着効果があるものもある。"]