ISO 11137-2:2013
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ISO 11137-2:2013
62442

Status : Published (Under review)

This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
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Format Language
std 1 194 PDF + ePub
std 2 194 Paper
  • CHF194
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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

  •  : Published
     : 2013-06
    : International Standard under systematic review [90.20]
  •  : 3
     : 68
  • ISO/TC 198
    11.080.01 
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This standard contributes to the following Sustainable Development Goal

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