ISO 11607-2:2019/Amd 1:2023 最終滅菌醫(yī)療器械包裝第2部分:成型、密封和裝配過程的驗(yàn)證要求,附錄1:風(fēng)險(xiǎn)管理的應(yīng)用
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management