Status : Published (Under review)
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
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Abstract

ISO 11137-2:2013 specifies methods for 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 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

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General information

  • Status
     : Published
    Publication date
     : 2013-06
    Stage
    : International Standard under systematic review [90.20]
  • Edition
     : 3
    Number of pages
     : 68
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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