scope:

1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE - Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This document covers radiation processes employing irradiators using a) the radionuclide 60Co or 137Cs; b) a beam from an electron generator; or c) a beam from an X-ray generator. 1.2 This document does not specify requirements for development, validation and routine control of a process for inactivating viruses or the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE - See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.1 This document does not detail specified requirements for designating a medical device as sterile. NOTE - Attention is drawn to regional and national requirements for designating medical devices as "sterile." See, for example, EN 556-1 or ANSI/AAMI ST67.