现行 YY/T 0467-2016
医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南 医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
发布日期:2016-01-26
实施日期:2017-01-01
分类信息
研制信息

归口单位: 全国医疗器械质量管理和通用要求标准化技术委员会(SAC/TC 221)

起草单位: 北京国医械华光认证有限公司

起草人: 米兰英、 郑一菡、 王慧芳、 陈志刚

标准简介

本标准规定了评定医疗器械安全和性能的公认基本原则,提供了有关重要标准和指南。本标准适用于医疗器械安全和性能的符合性评定

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最后更新时间 2025-09-02