Reference number
ISO/TS 11137-4:2020
ISO/TS 11137-4:2020
© ISO 2025
Technical Specification
ISO/TS 11137-4:2020
Sterilization of health care products — Radiation — Part 4: Guidance on process control
Edition 1
2020-06
2020-06
Technical Specification
ISO/TS 11137-4:2020
69443
Published
(Edition 1, 2020)
This publication was last reviewed and confirmed in 2024.
Therefore this version remains current.
Abstract
This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
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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
General information
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Status: PublishedPublication date: 2020-06Stage: International Standard confirmed [90.93]
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Edition: 1Number of pages: 55
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Technical Committee :ISO/TC 198ICS :11.080.01
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