ISO-11137-1 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 - 1ST EDITION - CURRENT -- See the following: ISO-11137-1-AM1


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 1ST EDITION - April 15, 2006
 FOR 1ST EDITION AMENDMENT 1 - July 15, 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.
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To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 11137-1:2006

Revision Level

1ST EDITION

Status

Current

Publication Date

April 15, 2006

Committee Number

ISO/TC 198