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Standard

SN EN ISO 11137-1:2015

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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.

Products specifications

  • Standard from INB
  • Published:
  • Effective:
  • Document type: EN
  • Pages
  • ICS: 11.080.99
  • Publisher: SNV
  • Distributor: SNV
  • National Committee: INB/NK 171

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