ISO14971-2019年最新中文版.pdf

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 曰四小 版权保护的文件 ©ISO 2019 版权所有。 除非另有说明， 或者在实施时需要，否则，未经事先书面许 可，不得以任何形式或手段，通过电子或机械手段（包括影印或在互联 网或内部网上发布）以任何形式复制或使用本出版物的任何部分。 书面 许可。 可以从以下地址的ISO或请求者所在国家的ISO成员体内请求 许可。 O版权局 IS CP 401• 章de Blandonnet 8 CH-1214 Ve nier, 日内瓦 电话 ： +41 22 749 01 11 传真： +41 22 749 09 47 电子邮件： copyright@iso.o g 网站： www.iso.o g 在瑞士出版 ..L.._._ • 目 U 吉 ··········································································································iv ． 介绍··········································································································vi • 1范围·······································································································1 • 2 规范性弓 I 用文件···················································································1 • 3术语和定义····························································································1 • 4 风险管理体系的—般要求………………………………………………………….7 • 4.1 风险管理流程 ．．．．．．．．．．．．…..…… ….. …… ….. …· ….. …... ….. …··7 • 4.2 管理职责 ···························································································8 • 4.3 人员能力9 • 4.4 风险管理计划………… …... … …· ……... … g • 4.5 风险管理文件…….. ……… …... ……… …· …….. …········10 • 5 风险分析 ····························································································10 . . • 5 1 风险分析过程….. ….. …… …... …… ……... …·······10 • 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·······························