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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
    Edition: 2015
    $497.46
    / user per year

Description of BS EN ISO 11137-1:2015 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.

Standard NumberBS EN ISO 11137-1:2015
TitleSterilization of health care products. Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
StatusWithdrawn
Publication Date2015-07-31
Withdrawn Date2019-11-27
Identical National Standard OfISO 11137-1:2015, EN ISO 11137-1:2015
DescriptorsGamma-radiation, Radiation measurement, Ionizing radiation, Sterilization (hygiene), Quality assurance, Medical instruments, Medical equipment, Documents, Process specification, Electron beams, Medical technology, Records (documents), Calibration, X-rays, Verification, Maintenance, Radiation, Quality control
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 580 90757 9
PublisherBSI
Pages54

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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