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ISO/TS 11135-2:2008Withdrawn

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1

Stérilisation des produits de santé — Oxyde d'éthylène — Partie 2: Directives relatives à l'application de l'ISO 11135-1

This edition has been replaced by ISO 11135:2014.

Abstract / scope

ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification.

This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

Life cycle

Amendments & corrigenda

ISO/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

Replaces

ISO 11135:1994WithdrawnMedical devices — Validation and routine control of ethylene oxide sterilizationInternational Standard · Published 27 Jan 1994 · ISO/TC 198ISO 11135:1994/Cor 1:1994WithdrawnMedical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrigendum 1International Standard · Published 27 Oct 1994 · ISO/TC 198

Replaced by

ISO 11135:2014PublishedSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 7 Jul 2014 · ISO/TC 198