IEC 60601シリーズの最終ドラフト版発行(6/8更新)
安全規格情報 2020.06.086月8日更新
FDISへの意見募集が締め切られたため,販売終了しています。
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4月24日に下記の医用電気機器の複数の安全規格のFDIS(最終ドラフト)が発行,販売されています。
IEC 60601-1/AMD2:2020 PRV
Amendment 2 - Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
IEC 60601-1-2/AMD1:2020 PRV
Amendment 1 - Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6/AMD2:2020 PRV
Amendment 2 - Medical electrical equipment - Part 1-6:
General requirements for basic safety and essential performance - Collateral standard: Usability
IEC60601-1-8/AMD2:2020 PRV
Amendment 2 - Medical electrical equipment - Part 1-8:
General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-11/AMD1:2020 PRV
Amendment 1 - Medical electrical equipment - Part 1-11:
General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-12/AMD1:2020 PRV
Amendment 1 - Medical electrical equipment - Part 1-12:
General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
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