EN ISO 11137-1:2006/A1:2013 醫(yī)療保健產(chǎn)品.輻射滅菌.第1部分:發(fā)展要求,驗證和對醫(yī)療器械滅菌過程的常規(guī)控制 包含修改件A1,2013
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/Amd 1:2013)