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 (ISO 11135:2014)

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.

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11135:2014)

1.1 Im Anwendungsbereich enthalten
Diese Internationale Norm legt Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens mit Ethylenoxid für Medizinprodukte im Rahmen der Industrie sowie in Einrichtungen der Gesundheitsfürsorge fest und erkennt die Ähnlichkeiten und Unterschiede zwischen den beiden Anwendungen an.
ANMERKUNG 1 Zu den Ähnlichkeiten zählen das gemeinsame Erfordernis für Qualitätssysteme, Mitarbeiter-schulungen und die ordnungsgemäßen Sicherheitsmaßnahmen. Die Hauptunterschiede beziehen sich auf die speziellen physikalischen und organisatorischen Bedingungen in Einrichtungen der Gesundheitsfürsorge sowie auf den Ausgangszustand der wiederverwendbaren Medizinprodukte, die zur Sterilisation vorgelegt werden.
ANMERKUNG 2 Einrichtungen der Gesundheitsfürsorge unterscheiden sich von den Herstellern der Medizinprodukte durch die physikalische Gestaltung der Verarbeitungsbereiche, durch die verwendete Ausrüstung und durch die Verfüg-barkeit von Mitarbeitern mit dem entsprechenden Ausbildungsstand und den entsprechenden Erfahrungen. Die primäre Aufgabe von Einrichtungen der Gesundheitsfürsorge besteht in der Pflege von Patienten; das Wiederaufbereiten von Medizinprodukten ist nur eine der zahlreichen Tätigkeiten, die im Rahmen dieser Aufgabe durchgeführt werden.
ANMERKUNG 3 In Bezug auf den Ausgangszustand von Medizinprodukten sterilisieren die Hersteller von Medizin-produkten im Allgemeinen große Stückzahlen ähnlicher Medizinprodukte, die aus Neuware hergestellt wurden. Einrichtungen der Gesundheitsfürsorge müssen andererseits sowohl neue als auch wiederverwendbare Medizinprodukte unterschiedlicher Arten und mit schwankender Keimbelastung handhaben und behandeln. Folglich sehen sie sich vor der Sterilisation mit zusätzlichen Herausforderungen der Reinigung, Bewertung, Vorbereitung und Verpackung eines Medizinprodukts konfrontiert. In der vorliegenden Internationalen Norm werden für Einrichtungen der Gesundheitsfürsorge spezifische alternative Herangehensweisen und Leitlinien entsprechend gekennzeichnet.
ANMERKUNG 4 EO-Gas und dessen Gemische sind wirksame Sterilisationsmittel, die vorrangig bei wärme- und feuchteempfindlichen Medizinprodukten verwendet werden, die nicht dampfsterilisiert werden können.
ANMERKUNG 5 Obgleich der Anwendungsbereich dieser Internationalen Norm auf Medizinprodukte begrenzt ist, legt er Anforderungen fest und liefert Anleitungen, die für andere Produkte für die Gesundheitsfürsorge gelten können.
1.2 Nicht im Anwendungsbereich enthalten
1.2.1 Diese Internationale Norm legt keine Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Verfahrens der Inaktivierung der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit fest. In einigen Ländern wurden spezifische Empfehlungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet.
ANMERKUNG Siehe ISO 22442-1, ISO 22442-2 und ISO 22442-3.
1.2.2 Diese Internationale Norm enthält keine ausführlichen Angaben zur Festlegung einer Anforderung an die Bezeichnung eines Medizinprodukts, das als steril gekennzeichnet ist.
ANMERKUNG Zu beachten sind nationale oder regionale Anforderungen an die Bezeichnung von Medizinprodukten die als 'steril' gekennzeichnet sind. Siehe zum Beispiel EN 556-1 oder ANSI/AAMI ST67.
1.2.3 Diese Internationale Norm legt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der Herstellung von Medizinprodukten fest.

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 (ISO 11135:2014)

L'ISO 11135:2014 spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine du procédé de stérilisation des dispositifs médicaux à l'oxyde d'éthylène dans l'industrie et dans les établissements de santé, et reconnaît les similitudes et différences entre les deux applications.

Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 11135:2014)

Standard EN ISO 11135 določa zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov z etilenoksidom za medicinske naprave v industrijske in zdravstvene namene, in njegovo sprejemanje podobnosti in razlik med tema dvema uporabama.

General Information

• Status: Published
• Publication Date: 15-Jul-2014
• Withdrawal Date: 30-Jul-2017
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Jul-2014
• Completion Date: 16-Jul-2014
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST 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 (ISO 11135:2014)

Relations

• Replaces: CEN ISO/TS 11135-2:2008/AC:2009 - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008/Cor 1:2009)
• Effective Date: 23-Jul-2014
• Replaces: EN ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
• Effective Date: 05-Mar-2011
• Replaces: CEN ISO/TS 11135-2:2008 - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
• Effective Date: 05-Mar-2011
• Amended By: 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 - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
• Effective Date: 24-Feb-2016
• Revised: prEN ISO 11135 - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2024)
• Effective Date: 29-Jul-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2014
1DGRPHãþD
SIST EN ISO 11135-1:2007
SIST-TS CEN ISO/TS 11135-2:2008
SIST-TS CEN ISO/TS 11135-2:2008/AC:2009
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR(WLOHQRNVLG=DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH,62
Sterilization of health-care products - Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO 11135:2014)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 11135:2014)
Stérilisation des produits de santé - Oxyde d'éthylène - Exigences pour le
développement, la validation et la vérification de routine d'un processus de stérilisation
pour les appareils médicaux (ISO 11135:2014)
Ta slovenski standard je istoveten z: EN ISO 11135:2014
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11135
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.080.01 Supersedes CEN ISO/TS 11135-2:2008, EN ISO 11135-
1:2007
English Version
Sterilization of health-care products - Ethylene oxide -
Requirements for the development, validation and routine control
of a sterilization process for medical devices (ISO 11135:2014)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Exigences de développement, de validation et de contrôle Ethylenoxid - Anforderungen an die Entwicklung,
de routine d'un processus de stérilisation pour des Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 11135:2014) Sterilisationsverfahrens für Medizinprodukte (ISO
11135:2014)
This European Standard was approved by CEN on 28 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11135:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC .5

Foreword
This document (EN ISO 11135:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of
health care products” in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices”
the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 11135-2:2008, EN ISO 11135-1:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, ZB, which are integral parts of this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11135:2014 has been approved by CEN as EN ISO 11135:2014 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 90/385/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this
standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered
4,5,6,7,8,9,10,11,12 8.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 11135
Second edition
2014-07-15
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
Reference number
ISO 11135:2014(E)
©
ISO 2014
ISO 11135:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11135:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Quality management systems .11
4.1 Documentation .11
4.2 Management responsibility .11
4.3 Product realization .11
4.4 Measurement, analysis and improvement — Control of nonconforming product .11
5 Sterilizing agent characterization .11
5.1 General .11
5.2 Sterilizing agent .12
5.3 Microbicidal effectiveness .12
5.4 Material effects.12
5.5 Safety and the environment .12
6 Process and equipment characterization .12
6.1 General .12
6.2 Process characterization .12
6.3 Equipment characterization .
...