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ISO 11135:2014Published

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Stérilisation des produits de santé — Oxyde d'éthylène — Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux

A new edition is under development: ISO/FDIS 11135.

Abstract / scope

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Life cycle

Amendments & corrigenda

ISO 11135:2014/Amd 1:2018PublishedSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch releaseInternational Standard · Published 15 Oct 2018 · ISO/TC 198

Replaces

ISO 11135-1:2007WithdrawnSterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 27 Apr 2007 · ISO/TC 198ISO/TS 11135-2:2008WithdrawnSterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1Technical Specification · Published 17 Jul 2008 · ISO/TC 198ISO/TS 11135-2:2008/Cor 1:2009WithdrawnSterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 — Technical Corrigendum 1Technical Specification · Published 9 Feb 2009 · ISO/TC 198

Replaced by

ISO/DIS 11135Deleted (project abandoned)Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · ISO/TC 198ISO/FDIS 11135Under developmentSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · ISO/TC 198