ISO 11137-2:2006
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ISO 11137-2:2006
33953

Abstract 

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2006 defines product families for dose establishment and dose auditing.


General information 

  •  :  Withdrawn
     : 2006-04
     : 2006-07
     : 2006-07
  •  : 1
     : 60
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.01 Sterilization and disinfection in general

Life cycle


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