ISO 11137-1:2006 Preview

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.


General information

  • Current status : Published
    Publication date : 2006-04
  • Edition : 1
    Number of pages : 37
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.01
    Sterilization and disinfection in general

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