BS EN ISO 11135:2014+A1:2019

BS EN ISO 11135:2014+A1:2019

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

Status : Current   Published : July 2014



What is this standard about?

This standard details how to develop, validate and reliably reproduce an ethylene oxide sterilization process for medical devices that has appropriate microbicidal activity. In particular, this edition of the standard introduces amendments that clarify Annex E on single batch release.

Who is this standard for?

  • Medical devices manufacturers, specifically those producing small lots/clinical trial samples 
  • Healthcare regulatory bodies

Why should you use this standard?

Because it describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbicidal activity intended to sterilize medical devices.  It addresses the need for quality systems, staff training and proper safety measures.

In particular, the amendment supplies a revised version of Annex E. This provides a clear, practical approach to performing a simplified validation method for small lots such as those produced as clinical trial samples.

What’s changed since the last update?

The existing Annex E was unclear and ambiguous, leading to its misuse. It has been amended to: 

  • Clarify when the method should be applied: i.e. for research and development of new product or for clinical trial product
  • Clarify that data resulting from a single batch release study can be used to support a full validation study
  • Clarify that temperature and relative humidity sensors should be used to establish conditions in the sterilization load during both the half cycle and the full cycle comprising a single batch release

As well, the European Foreword and Annex Zs have been updated into the latest format and expectations to a level of detail which should help the listing of the standard in the Official Journal and the formal harmonization of the latest edition (New Medical Devices Regulation).

Standard NumberBS EN ISO 11135:2014+A1:2019
TitleSterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
Publication Date31 July 2014
Normative References(Required to achieve compliance to this standard)ISO 10012, ISO 10993-7, BS EN ISO 11737-2:2020, ISO 11138-2:2006, ISO 11737-2:2019, ISO 11737-1:2018, ISO 11140-1, ISO 11138-1:2006
Informative References(Provided for Information)ISO 14001, EN 556-1, ISO 9001, ISO 14040, ISO 22442-1, ISO 9000:2005, ISO 15883, ISO 14937:2009, ISO 22442-2, ISO 22442-3, IEC 61010-1, ISO 11607-1, TS 11139:2006, IEC 90003, ISO 11607-2, ISO 14161:2009, ISO 10993, TS 16775, AAMI ST67:2006, ISO 14971, AAMI ST41:1999, IEC 61010-2-040, NZS 4187, ISO/IEC Guide 99:2007, ISO 17664:2017, AAMI TIR28:2009, AAMI TIR15:2009, AAMI TIR16:2009
ReplacesBS EN ISO 11135-1:2007, DD CEN ISO/TS 11135-2:2008
International RelationshipsEN ISO 11135:2014/A1:2019,ISO 11135:2014/Amd 1:2018,ISO 11135:2014/Amd.1:2018
Amended ByCorrigendum, January 2020; Amendment, November 2019
DescriptorsMaintenance, Sterilizers, Performance, Acceptance (approval), Performance testing, Management, Hygiene, Verification, Sterile equipment, Personnel, Microbiological analysis, Instructions for use, Sterilization (hygiene), Medical equipment, Medical instruments, Quality control, Ethylene oxide
Title in FrenchStérilisation 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
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Ethylenoxid -Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte
ISBN978 0 539 12708 9
File Size1.448 MB

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