ISO 11137-1:2006/Amd 2:2018
保健品灭菌 辐射 第1部分:医疗器械灭菌过程的开发、验证和常规控制要求 修订 2:对 4.3.4 的修订
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4