International Standard
ISO 11137-1:2006
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Reference number
ISO 11137-1:2006
Edition 1
2006-04
© ISO 2024
International Standard
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Published (Edition 1, 2006)
This standard was last reviewed and confirmed in 2016. Therefore this version remains current.
This standard has 2 amendments.

ISO 11137-1:2006

Format
Language
CHF 173
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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.

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 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2013

Format
Language
CHF 18
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Amendment 2

Revision to 4.3.4 and 11.2

Edition 2018

Format
Language
CHF 18
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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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