DIN EN ISO 11137-1:2020-04
醫療保健產品滅菌 輻射 第1部分:醫療器械滅菌過程的開發、驗證和常規控制要求
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...