SANS 11137-1-2007 保健品消毒.辐射.第1部分:医疗仪器消毒方法的编制、核实及例行管理要求
Sterilization of health care products - Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. It does not require that biological indicators be used for the validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.