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 17664-1:2021 | Information 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 17664-2:2023 | Information 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 |

