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.


General information

  • Status :  Withdrawn
    Publication date : 2012-03
  • Edition : 2
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.01
    Sterilization and disinfection in general

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