ISO 11607-2:2019/Amd 1:2023
最终灭菌医疗器械的包装 第 2 部分:成型、密封和组装过程的验证要求 修正案 1:风险管理的应用
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — AMENDMENT 1: Application of risk management