Reference number
ISO 11137-3:2017
© ISO 2025
International Standard
ISO 11137-3:2017
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
Edition 2
2017-06
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Published (Edition 2, 2017)
This publication was last reviewed and confirmed in 2022. Therefore this version remains current.

ISO 11137-3:2017

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Abstract

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

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ISO 11137 Radiation sterilization package

This package provides the foundational requirements (Part 1), specific methods for establishing the sterilization dose (Part 2), essential guidance on accurate dose measurement (Part 3), and practical advice on process control (TS Part 4), offering a holistic approach from development to routine monitoring.

  • ISO 11137-1:2025
  • ISO 11137-2:2013
  • ISO 11137-3:2017
  • ISO/TS 11137-4:2020
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General information

  • Status
     : Published
    Publication date
     : 2017-06
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 2
    Number of pages
     : 41
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • 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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