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.
Status: PublishedPublication date: 2006-04
Edition: 1Number of pages: 37
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
This standard contributes to the following Sustainable Development Goal:
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ISO 11137:1995/Amd 1:2001Withdrawn
ISO 11137:1995/Cor 1:1997
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Corrigenda / AmendmentsPublished
ISO 11137-1:2006/Amd 1:2013Published
ISO 11137-1:2006/Amd 2:2018
Will be replaced byUnder development
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