European Committee for Standardization

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
 N EN ISO 11137-1

Annotation

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

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.

NOTE See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3.

This part of ISO 11137 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.