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.

1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.3 This document 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.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.

NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety requirements for occupational safety related to radiation.

1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices