Reference number
ISO 11137-2:2012
© ISO 2025
ISO 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Edition 2
2012-03
Withdrawn
Withdrawn (Edition 2, 2012)

Abstract

ISO 11137-2:2011 specifies methods of 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 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

General information

  • Status
     : Withdrawn
    Publication date
     : 2012-03
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 2
    Number of pages
     : 70
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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