ISO 11137-2:2012
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ISO 11137-2:2012
51238

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 

  •  :  Withdrawn
     : 2012-03
  •  : 2
     : 70
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.01 Sterilization and disinfection in general

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