KS C IEC TR 60601-4-1-2020-医用电气设备.第4-1部分:指南和解释.医用电气设备和具有一定自主权的医用电气系统-国家数字标准馆

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의료용 전기기기 — 제4-1부: 지침 및 해석 — 자율성 지수를 사용하는 의료용 전기기기 및 의료용 전기 시스템 医用电气设备.第4-1部分:指南和解释.医用电气设备和具有一定自主权的医用电气系统

发布日期： 2020-12-30

                该标准旨在通过具有自主性指数（以后称为DOA）的ME机器（MEE）或ME系统（MES）的详细风险管理流程和执行使用适应性工程流程所需的主要决策和步骤，支持制造商。此后，ME机器或ME系统称为MEE或MES。

이 표준은 자율성 지수(이후 DOA라 한다)를 갖는 ME기기(MEE) 또는 ME시스템(MES)의 상세한 위험관리 프로세스와 사용적합성 공학 프로세스를 수행하기 위해 필요한 주요 결정 사항과 단계를 통해 제조자를 지원하는 것을 목적으로 한다. 이후 ME기기 또는 ME시스템을 MEE 또는 MES라 한다.

分类信息

发布单位或类别：韩国-韩国标准

ICS分类： 11.040.01医疗设备 - 医疗设备综合

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