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

Abstract  Preview

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.


General information 

  •  :  Published
     : 2013-06
  •  : 3
     : 68
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.01 Sterilization and disinfection in general

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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