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DS/EN ISO 11137-1:2015/A2:2019
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
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.
Danish Standards [ds]