Status : Published (To be revised)
This standard was last reviewed and confirmed in 2016. Therefore this version remains current.
This standard will be replaced by ISO/FDIS 11137-1
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Abstract

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.

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  • ISO 11137-3:2017
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    Part 3: Guidance on dosimetric aspects of development, validation and routine control

General information

  • Status
     : Published
    Publication date
     : 2006-04
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 1
    Number of pages
     : 37
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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