BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

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BS EN ISO 11135:2014

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

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PDF

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HARDCOPY



What is this standard about?

This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.  

Who is this standard for?

Anyone responsible for sterilizing medical devices in both industrial and health care settings.

Why should you use this standard? 

It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.  

It tackles the need for quality systems, staff training and proper safety measures and covers the following points:

  • Quality management systems
  • Appropriate safety measures
  • Equipment characterization, product and process definition activities
  • Validation of the sterilization process, including installation qualification, operational qualification and performance qualification
  • Routine monitoring and control, including product release from sterilization
  • Requalification and assessment of change
  • Methodology for the validation and routine processing of single manufacturing lots
  • Comprehensive guidance on all of the above

What’s changed since the last update?

This standard combines content from both BS EN ISO 11135-1:2007 and BS EN ISO 11135-2:2015, replacing both those standards. It also adds additional information.




Standard NumberBS EN ISO 11135:2014
TitleSterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
StatusCurrent
Publication Date31 July 2014
Cross ReferencesISO 10012, ISO 10993-7, ISO 11138-1:2006, ISO 11138-2:2009, ISO 11140-1, ISO 11737-1, ISO 11737-2, ISO 13485:2003/Corrigendum 1:2009, ISO 9000:2005, ISO 9001, ISO 10993, ISO 11607-1, ISO 11607-2, ISO 14001, ISO 14040, ISO 14161:2009, ISO 14937:2009, ISO 14971, ISO 15883, ISO 17664, ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO/IEC Guide 99:2007, ISO/IEC 90003, ISO/TS 11139:2006, ISO/TS 16775, IEC 61010-1, IEC 61010-2-040, ANSI/AAMI ST41:1999, ANSI/AAMI ST67:2006, AAMI TIR15:2009, AAMI TIR16:2009, AAMI TIR28:2009, AS/NZS 4187, EN 556-1, 94/9/EC, 90/385/EEC, 93/42/EEC
ReplacesBS EN ISO 11135-1:2007, DD CEN ISO/TS 11135-2:2008
International RelationshipsEN ISO 11135:2014,ISO 11135:2014
Amended ByCorrigendum, January 2015.
Draft Superseded By11/30244091 DC
DescriptorsMedical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management
ICS11.080.01
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
CommitteeCH/198
ISBN978 0 580 89221 9
PublisherBSI
FormatA4
DeliveryYes
Pages94
File Size2.111 MB
Price£264.00


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