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Norm

ÖNORM EN ISO 11137-1

Issue date: 2013 12 15

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013) (consolidated version)

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. This part of...
Withdrawn: 2015 11 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 51 Pages
Language:
German | English
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. This part of ISO 11137 covers radiation processes employing irradiators using, a) the radionuclide (60)Co or (137)Cs, b) a beam from an electron generator or c) a beam from an X-ray generator. This part of ISO 11137 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 Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile. This part of ISO 11137 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 11137 does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release. This part of ISO 11137 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities. This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed devices.
ÖNORM EN ISO 11137-1
2020 04 01
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ÖNORM EN ISO 11137-1
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2001 03 01
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1999 10 01
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ÖNORM EN 552
1994 09 01
Sterilization of medical devices - Validation and routine control of sterilization irradiation
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Issue date : 2006 04 19
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