I.S. EN ISO 14971:2019&A11:2021现行
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
出版：National Standards Authority of Ireland
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基本信息
标准编号： I.S. EN ISO 14971:2019&A11:2021
标准类别：Standard
出版单位：National Standards Authority of Ireland
标准页数：0
标准简介
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
本标准替代的旧标准
等同采用的国际标准
EN ISO 14971:2019+A11:2021 - Identical
ISO 14971:2019 - Identical
EN ISO 14971:2019 - Identical
