ISO 11137-2:2013 Preview

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

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

  • Current status : Published
    Publication date : 2013-06
  • Edition : 3
    Number of pages : 68
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.01
    Sterilization and disinfection in general

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