Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
医疗保健产品的灭菌-辐射-第1部分:医疗器械灭菌过程的开发、验证和常规控制要求 包括A1:2013和A2:2019
Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or X-ray generator.