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About This Item
Full Description
ISO 11137-2:2011 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Document History
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ISO 11137-2:2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose- Most Recent
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ISO 11137-2:2012
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose- Historical Version
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ISO 11137-2/Cor1:2009
Corrigendum- Historical Version
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ISO 11137-2:2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose- Historical Version
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ISO 11137:1995
Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization- Historical Version