AAMI TIR38:2019-医疗器械安全保证案例报告指南-国家数字标准馆

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Medical device safety assurance case report guidance 医疗器械安全保证案例报告指南

发布日期： 2019-01-25

本技术信息报告提供了如何完成保证案例报告的指导，以符合FDA对输液泵的新附加上市前要求。它包括一个详细但严格假设的医疗设备领域的例子。

This technical information report provides guidance on how to complete an Assurance Case Report in order to comply with the new additional FDA pre-market requirements for infusion pumps. It includes a detailed but strictly hypothetical example from the medical device domain.

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发布单位或类别：美国-美国医疗器械促进协会

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BS PD IEC/TR 80001-2-9-2017

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风险管理应用于包含医疗设备的IT网络 - 第2-9部分:应用指南 - 使用安全保证案例证明对IEC/TR 80001-2-2安全功能的信心的指导

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