ISO 11137-1:2006/Amd 2:2018 保健品滅菌 輻射 第1部分:醫(yī)療器械滅菌過程的開發(fā)、驗證和常規(guī)控制要求 修訂 2:對 4.3.4 的修訂
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