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.
Status: WithdrawnPublication date: 2012-03
Edition: 2Number of pages: 70
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
ISO 11137-2:2006/Cor 1:2009
ISO 11137-2:2012Stage: 95.99
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