ISO 14971-2019 医疗器械——风险管理对医疗器械的应用（中文版）.pdf

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1、国际标准ISO标准14971第三版2019-12医疗设备—风险管理在医疗设备中的应用Dispositifsmédicaux-应用德拉GESTIONDESrisques辅助dispositifsmédicaux©ISO2019•前言··········································································································iv•介绍·····················································

2、·····················································vi•1范围·······································································································1•2规范性引用文件···················································································1•3术语和定义················

3、············································································1•4风险管理体系的一般要求···································································7•4.1风险管理流程···················································································7•4.2管理职责···················

4、·········································································8•4.3人员能力····························································································9•4.4风险管理计划····················································································9•4.5风险管理文

5、件··················································································10•5风险分析····························································································10•5.1风险分析过程··················································································10

6、•5.2预期用途和合理可预见的滥用·····················································10•5.3识别与安全有关的特性·································································11•5.4识别危害和危险情况·····································································11•5.5风险估算··································

7、························································11•6风险评估·····························································································12•7风险控制·····························································································12•7.1风险控制方案分析·······

8、···············································