EN ISO 14971:2019について

EN ISO 14971:2019について

本邦においては、ISOなどの国際規格はJIS(Japanese Industrial Standards)として国内規格に取り入れられる。同様に欧州ではEN(European Norm)として取り入れられている。
一般に国際規格は本文である要求事項とAnnex(附属資料)から出来ている。ISO加盟各国は、自国の規格として取り入れる際には、これら本文やAnnexを変更することは許されていない。
唯一、Annex Zsを追加することのみ可能である。

EN ISO 14971:2019

医療機器リスクマネジメント規格であるISO 14971:2019に対応する最新のEN規格は「EN ISO 14971:2019+A11:2021」である。
EU MDR・IVDRの整合規格にも認定されている。
EN ISO14971:2019でISO14971:2019と同等となり、A11:2021(2021年に発出された追補)でAnnex Zsが追加された。
Annex ZAでMDRの、ZBでIVDRの一般的安全性及び性能の要求事項(GSPR)と、EN ISO14971の要求事項との関係が示されている。

2012年版にあった差分について

EN ISO14971:2012では「Contents Deviations」(以下、CD)と呼ばれる以下に示すISO 14971との7つの差分があった。

  1. “negligable risk”(無視可能なリスク)の扱い
  2. リスクの受容可能性についての製造業者の自由裁量権
  3. “as far as possible(可能な限り)”のリスク低減 VS “as low as reasonably possible(合理的に実行可能まで低く)“のリスク低減
  4. あらゆるリスクに対するRisk/Benefit Analysis (リスク/便益分析)の適用
  5. リスクコントロール手段についての裁量
  6. 初期リスクコントロール手段についての裁量
  7. 残留リスクについてのユーザへの情報提供

それに対し、最新版ではCDは解消された。
これについて、MED DEVICE ONLINEでは次のように述べている。

「コンテンツの逸脱」と呼ばれるセクションの使用は、もはや調和された標準の一部ではない。
EN ISO 14971:2012の前版では、このセクションの使用に関して多くの混乱があり、引用された「コンテンツの逸脱」にエラーがあり、規制に準拠している企業に多くの問題を引き起こしていた。
NBの間にも意見の不一致があり、状況はさらに悪化した。
EN ISO 14971:2012は、その意図であったISO 14971:2007よりも安全なデバイスにはつながらなかった。

JISとの差分について

なおISO 14971:2019とJIS T 14971:2020との間には差分はない。 

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/191121P.html” title=”医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-008.html” title=”【セミナービデオ】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-026.html” title=”【ISO 14971:2019対応】リスクマネジメント規程・手順書・様式” content=”ISO14971:2019に沿った形のリスクマネジメント規程・手順書・様式です。
医療機器設計におけるリスク分析は、ISO-14971に従って実施されています。
リスクマネジメント実施のための手順や様式を整えておかなければなりません。”]

[blogcard url=”https://xn--2lwu4a.jp/qms-md/” title=”QMS(手順書)ひな形 医療機器関連” ]

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