New project
ISO/AWI 11137-2
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Reference number
ISO/AWI 11137-2
Edition 4
© ISO 2024
New project
Under development
Drafting has started.
Will replace ISO 11137-2:2013

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.

General information

  • Status
     : Under development
    Stage
    : New project approved [10.99]
  • Edition
     : 4
  • Technical Committee :
    ISO/TC 198
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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