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日本代购-【JIS T 62366-1:2022対応】取扱説明書作成手順書
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日本代购-医療機器企業は、2024年3月31日までに、JIS T 62366-1:2022 「医療機器-第1部:ユーザビリティエンジニアリングの医療機器への適用」(IEC 62366-1:2015+AMD1:2020)への適合をもって、医療機器基本要件基準の第9条および第16条等で規定するユーザビリティへの適合をしなければなりません。 ユーザビリティエンジニアリングを実施して、使用エラーのない医療機器を設計開発することが目的です。 ユーザビリティエンジニアリングにおけるインターフェースには「取扱説明書」が含まれます。 本取扱説明書等の作成手順書では、JIS T 62366-1:2022を遵守した「取扱説明書」の作成手順をご提供いたします。 著者情報 株式会社イーコンプライアンス 代表取締役 村山 浩一 出版社 株式会社イーコンプレス 内容情報 ※CD-Rにて納品いたします。 【目次】 1. 目的 2. 適用範囲 3. 用語の定義 4. 役割と責任 5. 取扱説明書作成の原則 6. 取扱説明書の構成  6.1 取扱説明書の構成と内容  6.2 サービスマニュアルの構成と内容 7. リスク分析 8. クリティカルまたはセミクリティカルな医療機器において提供すべき情報  8.1 洗浄   8.1.1 洗浄前の準備   8.1.2 自動洗浄   8.1.3 用手洗浄   8.1.4 手動洗浄  8.2 消毒   8.2.1 自動消毒   8.2.2 手動消毒  8.3 乾燥  8.4 滅菌  8.5 サイバーセキュリティ  8.6 点検・整備 9. 取扱説明書の作成手順  9.1 取扱説明書の作成  9.2 形成的評価の実施(ユーザビリティエンジニアリング試験)   9.2.1 形成的評価の計画   9.2.2 形成的評価の実施  9.3 取扱説明書の校正・修  9.4 総括的評価の実施(ユーザビリティエンジニアリング試験)   9.4.1 ユーザビリティエンジニアリング試験の計画   9.4.2 総括的評価の実施   9.4.3 取扱説明書の承認 10. デザインレビュによる審査  10.1 設計アウトプット審査会(DR2) 11. 取扱説明書の改訂 12. 参考 13. 付則 注意事項 お使いのモニターの発色具合によって、実際のものと色が異なる場合がございます。様式はCD-Rで納品 ※本CD-Rに含まれる様式を閲覧するためには、CDドライブを装備したPCが必要です。
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