ISO 11135-1:2007 卫生保健品灭菌.环氧乙烷.第1部分:医疗设备消毒过程的制定、确认和常规控制的要求
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
This part of ISO 11135 specifies requirements for the development, validation and routine control of an
ethylene oxide sterilization process for medical devices.
NOTE 1 Although ...