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BSI BS EN ISO 11137-1:2015

Sterilization of health care products. Radiation -- Requirements for development, validation and routine control of a sterilization process for medical devices
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BSI BS EN ISO 11137-1:2015

Sterilization of health care products. Radiation -- Requirements for development, validation and routine control of a sterilization process for medical devices

PUBLISH DATE 2015
PAGES 54
BSI BS EN ISO 11137-1:2015
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.
SDO BSI: British Standards Institution
Document Number ISO 11137-1
Publication Date July 31, 2015
Language en - English
Page Count 54
Revision Level
Supercedes
Committee CH/198
Publish Date Document Id Type View
July 31, 2015 BS EN ISO 11137-1:2015 Revision
Aug. 31, 2006 BS EN ISO 11137-1:2006 Revision
Aug. 31, 2013 BS EN ISO 11137-1:2006+A1:2013 Consolidated