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Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

02-04-2025

Publisher

International Organization for Standardization

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$418.26

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Summarise this standard

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This document does not specify requirements for the sterilization of used or reprocessed devices.

Committee	ISO/TC 198
DocumentType	Standard
Pages	39
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11137-1:2006 ISO 11137-1:2006/Amd 1:2013 ISO 11137-1:2006/Amd 2:2018
UnderRevision	ISO 11137-1:2006/Amd 2:2018

Standards	Relationship
SS-EN ISO 11137-1:2026	Identical
BS EN ISO 11137-1:2026	Identical

Frequently Asked Questions

ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. It is an international standard published by International Organization for Standardization (ISO).

ISO 11137-1 is used by healthcare product manufacturers and sterilisation providers using ionising radiation. It is an international standard published by International Organization for Standardization (ISO).

ISO 11137-1 is International Organization for Standardization (ISO)'s standard for radiation sterilisation of healthcare products, while ISO 11135 covers ethylene oxide sterilisation of healthcare products (International). ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes.

ISO 11137-1 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. In practice it is applied by healthcare product manufacturers and sterilisation providers using ionising radiation.

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ISO 11137-1:2025

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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What is ISO 11137-1?

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