This standard has been revised by ISO 11137-2:2013
Abstract
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.
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Status: WithdrawnPublication date: 2012-03
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Edition: 2Number of pages: 70
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- ICS :
- 11.080.01 Sterilization and disinfection in general
Life cycle
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Previously
WithdrawnISO 11137-2:2006
WithdrawnISO 11137-2:2006/Cor 1:2009
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Now
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Revised by
PublishedISO 11137-2:2013
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