ISO14971-2019中文版

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• 1范围·······································································································1 • 2 规范性弓 I用文件···················································································1 • 3术语和定义····························································································1 • 4 .7 风险管理体系的—般要求………………………………………………………… • 4.1 风险管理流程 ··7 ．．．．．．．．．．．．…..……............…..…….......…..…·…..…...…..… • 4.2 管理职责···························································································8 • 4.3 9 人员能力............................................................................................ • 4.4 g 风险管理计划.............…………...........…...…..............…·……...…......... • 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··························································································11 • 6 风险评估····························································································12 • 7 风险控制·····························································································12 • 7.1 风险控制方案分析......…………..........…..……...….....…...………········13 • 7.2 实施风险控制措施.........…….............…..……...…...........……···········13 • 7.3 残留风险评估················································································13
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
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• 7.4 利益风险分析…..........…..……............…...…..................……...…·······14 • 7.5 风险控制措施带来的风险……………………………………………………··14 • 7.6 风险控制的完整性......…………..........…..……...….......………·…·········14 • 8 总体残留风险评估............…....................…..….....…...……........…······14 • 9 风险管理审查……...............…...............…..……...….......…·……·············15 • 10 生产和后期制作活动·…..……·….......…..……..….......…·………···········15 • 10.1 -舟�································································································15 • 10.2信息收集·······················································································15
• .目...>U..L_吉._·····································································iv
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