ISO 11137-2:2013
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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.


  • Document published on: 2013-06-01
    Edition: 3 (Monolingual) ICS: 11.080.01
    Status: Published Stage: 60.60 (2013-05-21)
    TC/SC: ISO/TC 198 Number of Pages: 68
  • Revises: ISO 11137-2:2012

  • No corrigenda or amendments available

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