ISO 11137-1:2006/Amd 1:2013 保健產(chǎn)品的滅菌.輻射.第1部分:醫(yī)療器械滅菌過程的制定、確認(rèn)、和常規(guī)控制的要求.修改件1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1