Draft
International Standard
ISO/DIS 11137-2
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Reference number
ISO/DIS 11137-2
Edition 4
© ISO 2026
Draft International Standard

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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 11137-2:2013

ISO/DIS 11137-2

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Format
CHF 135
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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

    You can help develop this draft international standard by contacting your national member

    Stage
    : DIS ballot initiated: 12 weeks [40.20]
  • Edition
     : 4
    Number of pages
     : 106
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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