ISO 11137-1:2006/Amd1:2013 - $19.00   BUY NOW

- Amendment 1

ISO 11137-1:2006/Amd1:2013 Publication Description:

--- Abstract Source: ISO 11137-1:2006/Amd1:2013 ---

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.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Sterilization-General (11.080.01)

ICS Related Standards

Cart Document Number Document Title
$209.00 ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
$189.00 ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
$180.00 ISO/TS 11135-2:2008 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
$185.00 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
$209.00 ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$103.00 ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
$185.00 ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
$45.00 ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
$68.00 ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
$68.00 ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
$68.00 ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
$103.00 ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
$162.00 ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
$156.00 ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
$138.00 ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
$162.00 ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
$68.00 ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
$185.00 ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
$103.00 ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
$209.00 ISO/TS 13004:2013 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
$185.00 ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
$19.00 ISO 13408-1:2008/Amd1:2013 - Amendment 1
$68.00 ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
$68.00 ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization
$103.00 ISO 13408-4:2005 Aseptic processing of health care products - Part 4: Clean-in-place technologies
$103.00 ISO 13408-5:2006 Aseptic processing of health care products - Part 5: Sterilization in place
$103.00 ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems
$19.00 ISO 13408-6:2005/Amd1:2013 - Amendment 1
$138.00 ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
$162.00 ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
$209.00 ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
$185.00 ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
$162.00 ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
$103.00 ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
$185.00 ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
$185.00 ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
$209.00 ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
$162.00 ISO 18362:2016 Manufacture of cell-based health care products - Control of microbial risks during processing
$162.00 ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
$209.00 ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
$185.00 ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
$185.00 ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
$185.00 ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
$45.00 ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
$68.00 ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
$68.00 ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
$68.00 ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes