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协调标准 — 器械处理与再处理

官方来源EC Health — Harmonised Standards | 基于 CID (EU) 2021/1182(合并版)及修正案 CID (EU) 2026/193

协调标准列表(2条)

标准号标题摘要GSPR对应状态
EN ISO 17664-1:2021Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)GSPR 11.7(器械处理)现行有效
EN ISO 17664-2:2023Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)GSPR 11.7(器械处理)现行有效

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数据层源文件

eu_mdr/standards/standards-processing.json

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