ÖNORM EN ISO 11137-1

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. This part of ISO 11137 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. This part of ISO 11137 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile. This part of ISO 11137 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 11137 does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release. This part of ISO 11137 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities. This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed devices.