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 is limited to medical devices, this document can 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 is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE         For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.

1.2.1       This document does not specify requirements for designating a medical device as sterile.

NOTE         Regional and national requirements can designate 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         Regulations on safety requirements for occupational safety related to radiation can exist in some countries.

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