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 

  • Status
     :  Withdrawn
    Publication date
     : 2006-04
    Corrected version (en)
     : 2006-07
    Corrected version (fr)
     : 2006-07
  • Edition
     : 1
    Number of pages
     : 60
  • Technical Committee
     : ISO/TC 198 Sterilization of health care products
  • ICS
     :
    11.080.01 Sterilization and disinfection in general

Life cycle


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