Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide ⁶⁰Co or ¹³⁷Cs, a beam from an electron generator or a beam from an X-ray generator.

ISO 11137-1:2006 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 Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

Edition	2006
Standard Part No	1
Published Date	2006
Published By	International Standardization Organisation
Page Count	37

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