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ISO 11137-2:2013 Preview
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ISO 11137-2:2013 specifies methods for 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 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
General information
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Current status : PublishedPublication date : 2013-06
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Edition : 3Number of pages : 68
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- ICS :
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Sterilization and disinfection in general
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Revisions / Corrigenda
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Previously
ISO 11137-2:2012
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Now
ISO 11137-2:2013