SIST EN ISO 11135:2014
(Main)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)
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)
EN ISO 11135 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)
1.1.1 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 die gemeinsame Erfordernis für Qualitätssysteme, Mitarbeiterschulungen
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
Verfügbarkeit 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 Medizinprodukten
im Allgemeinen große Stückzahlen ähnlicher Produkte, 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 Im Allgemeinen ist die Sterilisation mit feuchter Hitze (auch als Dampfsterilisation bekannt) das
Verfahren der Wahl für Medizinprodukte und Artikel, die in Einrichtungen der Gesundheitsfürsorge sterilisiert werden.
Jedoch handelt es sich bei EO-Gas und dessen Gemischen um wirksame Sterilisationsmittel, die vorrangig bei wärmeund
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
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.
1.2.1 Diese Internationale Norm enthält keine ausführlichen Angaben zur Festlegung einer Anforderung an
die Bezeichnung eines Medizinprodukts als steril.
ANMERKUNG Zu beachten sind nationale oder regionale Anforderungen an die Bezeichnung von Medizinprodukten
als „steril“. Siehe zum Beispiel EN 556-1 oder ANSI/AAMI ST67.
1.2.2 Diese Internationale Norm legt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der
Herstellung von Medizinprodukten fest.
ANMERKUNG Für die Entwicklung, Validierung und Lenkung der Anwendung von Sterilisationsverfahren für Medizinprodukte
ist die effektive Durchführung definierter und dokumentierter Verfahren erforderlich. (...)
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)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11135:2014
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
SIST EN ISO 11135:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11135:2014
---------------------- Page: 2 ----------------------
SIST EN ISO 11135:2014
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.
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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
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
2
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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
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.
3
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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
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.
4
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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
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.
5
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SIST EN ISO 11135:2014
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SIST EN ISO 11135:2014
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
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SIST EN ISO 11135:2014
ISO 11135:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11135:2014
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 .13
7 Product definition .14
7.1 General .14
7.2 Product safety, quality and performance .15
7.3 Microbiological quality .15
7.4 Documentation .15
8 Process definition .15
9 Validation .16
9.1 General .16
9.2 Installation qualification, IQ .17
9.3 Operational qualification, OQ .17
9.4 Performance qualification, PQ .18
9.5 Review and approval of validation .20
10 Routine monitoring and control .22
11 Product release from sterilization .23
12 Maintaining process effectiveness
.23
12.1 General .23
12.2 Maintenance of equipment .24
12.3 Requalification .24
12.4 Assessment of change .24
12.5 Assessment of equivalence .25
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach .26
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach .27
Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers .29
© ISO 2014 – All rights reserved iii
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SIST EN ISO 11135:2014
ISO 11135:2014(E)
Annex D (informative) Guidance on the application of the normative requirements .32
Annex E (normative) Single Lot Release .74
Bibliography .76
iv © ISO 2014 – All rights reserved
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SIST EN ISO 11135:2014
ISO 11135:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 198, Sterilization of health care products.
ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008, both of which have
been technically revised and condensed into a single standard.
© ISO 2014 – All rights reserved v
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SIST EN ISO 11135:2014
ISO 11135:2014(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. Medical devices produced under
standard manufacturing conditions in accordance with the requirements for quality management
systems (see for example ISO 13485) might, prior to sterilization, have microorganisms on them, albeit
in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the
microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents
used to sterilize medical devices can generally best be described by an exponential relationship
between the numbers of microorganisms surviving and the extent of treatment with the ethylene
oxide (EO); inevitably this means that there is always a finite probability that a microorganism might
survive regardless of the extent of treatment applied. For a given treatment, the probability of survival
is determined by the number and resistance of microorganisms and by the environment in which the
organisms exist during treatment. It follows that the sterility of any one medical device in a population
subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is
defined in terms of the probability of there being a viable microorganism present on a medical device.
ISO 11135 describes requirements that, if met, will provide an ethylene oxide sterilization process
intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore,
compliance with the requirements ensures that validations conducted following this International
Standard will provide products that meet the defined requirements for sterile products with a high
degree of confidence. The specification for this probability is a matter for regulatory authorities and can
vary from country to country (see for example EN 556-1 and ANSI/AAMI ST67).
Generic requirements of the quality management systems for design and development, production,
installation and servicing are given in ISO 9001 and particular requirements for quality management
systems for medical device production are given in ISO 13485. The standards for quality management
systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness
of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization
is an example of such a process. For this reason, sterilization processes are validated for use, the
performance of the sterilization process monitored routinely and the equipment maintained.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor
associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable
for its intended use. Attention is therefore given to a number of considerations including:
— the microbiological status of incoming raw materials and/or components;
— the validation and routine control of any cleaning and disinfection procedures used on the product;
— the control of the environment in which the product is manufactured or reprocessed, assembled
and packaged;
— the control of equipment and processes;
— the control of personnel and their hygiene;
— the manner and materials in which the product is packaged;
— the conditions under which product is stored.
The type of contamination on a product to be sterilized varies and this impacts upon the effectiveness
of a sterilization process. Products that have been used in a health care setting and are being presented
for resterilization in accordance with the manufacturer’s instructions (see ISO 17664) are a special case.
There is the potential for such products to possess a wide range of contaminating microorganisms and
residual inorganic and/or organic contamination in spite of the application of a cleaning process. Hence,
it is important to pay particular attention to the validation and control of the cleaning and disinfection
processes used during reprocessing. Mixed product loads are common in health care facilities with
throughput volumes dictated by historical and predicted demand for sterile product.
vi © ISO 2014 – All rights reserved
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SIST EN ISO 11135:2014
ISO 11135:2014(E)
The requirements are the normative parts of ISO 11135 with which compliance is claimed. The guidance
given in the informative annexes is not normative and is not provided as a checklist for auditors. The
guidance in Annex D provides explanations and methods that are regarded as being suitable means for
complying with the requirements for industry and health care facilities.
The guidance, in Annex D, is intended for people who have a basic knowledge of the principles of EO
sterilization. Methods other than those given in the guidance can be used if they are effective in achieving
compliance with the requirements of ISO 11135.
The development, validation and routine control of a sterilization process comprises a number of
discrete but interrelated activities; e.g. calibration, maintenance, product definition, process definition,
installation qualification, operational qualification and performance qualification. While the activities
required by ISO 11135 have been grouped together and are presented in a particular order, ISO 11135
does not require that the activities be performed in the order in which they are presented. The activities
required are not necessarily sequential, as the programme of development and validation may be iterative.
It is possible that performing these different activities will involve a number of separate individuals
and/or organizations, each of whom undertakes one or more of these activities. This International
Standard does not specify the particular individuals or organizations to carry out the activities.
It is important that patient safety be addressed by minimizing exposure to EO and its by-products during
normal product use. ISO 10993-7 specifies limits for EO and ethylene chlorohydrin (ECH); however, no
exposure limits are set for ethylene glycol (EG) because risk assessment indicates that when EO residues
are controlled, it is unlikely that biologically significant residues of EG would be present.
© ISO 2014 – All rights reserved vii
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SIST EN ISO 11135:2014
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SIST EN ISO 11135:2014
INTERNATIONAL STANDARD ISO 11135:2014(E)
Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
This International Standard 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.
NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety
measures. The major differenc
...
SLOVENSKI STANDARD
oSIST prEN ISO 11135:2011
01-december-2011
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR(WLOHQRNVLG=DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH ,62',6
Sterilization of health-care products - Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO/DIS 11135:2011)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11135:2011)
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/DIS 11135:2011)
Ta slovenski standard je istoveten z: prEN ISO 11135
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11135:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 11135:2011
---------------------- Page: 2 ----------------------
oSIST prEN ISO 11135:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 11135
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2011
ICS 11.080.01 Will supersede 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/DIS
11135:2011)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Exigences pour le développement, la validation et la Ethylenoxid - Anforderungen an die Entwicklung,
vérification de routine d'un processus de stérilisation pour Validierung und Lenkung der Anwendung eines
les appareils médicaux (ISO/DIS 11135:2011) Sterilisationsverfahrens für Medizinprodukte (ISO/DIS
11135:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 204.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11135:2011: E
worldwide for CEN national Members.
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oSIST prEN ISO 11135:2011
prEN ISO 11135:2011 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 11135:2011
prEN ISO 11135:2011 (E)
Foreword
This document (prEN ISO 11135:2011) 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 document is currently submitted to the parallel Enquiry.
This document will supersede 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).
Endorsement notice
The text of ISO/DIS 11135:2011 has been approved by CEN as a prEN ISO 11135:2011 without any
modification.
3
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oSIST prEN ISO 11135:2011
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oSIST prEN ISO 11135:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 11135
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on
2000-09-15 2012-02-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ ORGANISATION INTERNATIONALE DE NORMALISATION
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 pour le développement, la validation et
la vérification de routine d'un processus de stérilisation pour les appareils médicaux
[Revision of first edition (ISO 11135-1:2007) and ISO/TS 11135-2:2008]
ICS 11.080.01
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2011
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oSIST prEN ISO 11135:2011
ISO/DIS 11135
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2011 – All rights reserved
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oSIST prEN ISO 11135:2011
ISO/DIS 11135
Contents Page
Foreword . vi
Introduction . vii
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Quality management systems . 10
4.1 Documentation . 10
4.2 Management responsibility . 10
4.3 Product realization . 10
4.4 Measurement, analysis and improvement — Control of nonconforming product . 10
5 Sterilizing agent characterization . 11
5.1 General . 11
5.2 Sterilizing agent . 11
5.3 Microbicidal effectiveness . 11
5.4 Material effects . 11
5.5 Safety and the environment . 11
6 Process and equipment characterization . 11
6.1 General . 11
6.2 Process characterization . 11
6.3 Equipment characterization . 12
7 Product definition . 13
7.1 General . 13
7.2 Product safety, quality and performance . 14
7.3 Microbiological quality . 14
7.4 Documentation . 14
8 Process definition . 14
9 Validation . 15
9.1 General . 15
9.2 Installation qualification . 15
9.2.1 Equipment . 15
9.2.2 Installation . 16
9.3 Operational qualification . 16
9.4 Performance qualification . 16
9.4.1 General . 16
9.4.2 Performance qualification — Microbiological . 17
9.4.3 Performance qualification — Physical . 17
9.5 Review and approval of validation . 18
10 Routine monitoring and control . 20
11 Product Release from sterilization . 21
12 Maintaining process effectiveness . 22
12.1 General . 22
12.2 Maintenance of equipment . 22
12.3 Requalification . 22
12.4 Assessment of change . 22
© ISO 2011 – All rights reserved iii
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oSIST prEN ISO 11135:2011
ISO/DIS 11135
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach . 24
A.1 General . 24
A.2 Procedure . 24
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach . 25
B.1 General . 25
B.2 Procedure . 25
Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers . 27
C.1 Temperature sensors . 27
C.2 Humidity sensors . 28
C.3 Biological Indicators . 28
Annex D (informative) Guidance on the application of the normative requirements . 30
D.1 Scope . 30
D.2 Normative requirements . 30
D.3 Terms and definitions . 30
D.4 Quality management systems . 30
D.4.1 Documentation . 30
D.4.2 Management responsibility . 30
D.4.3 Product realization . 31
D.4.4 Measurement, analysis and improvement — Control of non-conforming product . 31
D.5 Sterilizing agent characterization . 31
D.5.1 General . 31
D.5.2 Sterilizing agent . 32
D.5.3 Microbicidal effectiveness . 32
D.5.4 Material effects . 32
D.5.5 Safety and the environment . 32
D.6 Process and equipment characterization. 32
D.6.1 General . 33
D.6.2 Process characterization . 33
D.6.3 Equipment characterization . 34
D.7 Product definition . 37
D.7.1 General . 37
D.7.2 Product safety, quality and performance . 40
D.7.3 Microbiological quality . 41
D.7.4 Documentation . 41
D.8 Process definition . 41
D.9 Validation . 45
D.9.1 General . 45
D.9.2 Installation qualification . 45
D.9.3 Operational qualification . 47
D.9.4 Performance qualification . 49
D.9.5 Review and approval of validation . 52
D.10 Routine monitoring and control . 53
D.11 Product Release from sterilization . 55
D.12 Maintaining process effectiveness . 56
D.12.1 General . 56
D.12.2 Maintenance of equipment . 56
D.12.3 Requalification . 57
D.12.4 Assessment of change . 59
D.12.5 Assessment of equivalence . 60
D.13 Guidance on Annex A — Determination of lethal rate of the sterilization process —
Biological indicator/bioburden approach. 65
D.13.1 [A.1] General . 65
D.13.2 [A.2] Procedure . 67
D.14 Guidance on Annex B — Conservative determination of lethal rate of the sterilization
process — Overkill approach . 68
D.14.1 [B.1] General . 68
iv © ISO 2011 – All rights reserved
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oSIST prEN ISO 11135:2011
ISO/DIS 11135
D.14.2 [B.2] Procedure . 68
Annex E . 70
Bibliography . 72
© ISO 2011 – All rights reserved v
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oSIST prEN ISO 11135:2011
ISO/DIS 11135
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
ISO 11135 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 11135:20xx cancels and replaces ISO 11135-1:2007 Sterilization of health care products – Ethylene
oxide – Part 1: Requirements for the development, validation and routine control of a sterilization process for
medical devices and ISO/TS 11135-2:2008 Sterilization of health care products – Ethylene oxide – Part 2:
Guidance on the application of ISO 11135-1, both of which have been technically revised and condensed into
a single standard.
vi © ISO 2011 – All rights reserved
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oSIST prEN ISO 11135:2011
ISO/DIS 11135
Introduction
A sterile medical device is one that is free of viable microorganisms. Medical devices produced under
standard manufacturing conditions in accordance with the requirements for quality management systems (see
for example ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such
medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants
and thereby transform the non-sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to
sterilize medical devices can generally best be described by an exponential relationship between the numbers
of microorganisms surviving and the extent of treatment with the ethylene oxide (EO); inevitably this means
that there is always a finite probability that a microorganism may survive regardless of the extent of treatment
applied. For a given treatment, the probability of survival is determined by the number and resistance of
microorganisms and by the environment in which the organisms exist during treatment. It follows that the
sterility of any one medical device in a population subjected to sterilization processing cannot be guaranteed
and the sterility of a processed population is defined in terms of the probability of there being a viable
microorganism present on a medical device.
ISO 11135 describes requirements that, if met, will provide an ethylene oxide sterilization process intended to
sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the
requirements ensures that validations conducted following this standard will provide products that meet the
defined requirements for sterile products with a high degree of confidence. The specification for this probability
is a matter for regulatory authorities and may vary from country to country (see for example EN 556-1 and
ANSI/AAMI ST67).
Generic requirements of the quality management systems for design and development, production, installation
and servicing are given in ISO 9001 and particular requirements for quality management systems for medical
device production are given in ISO 13485. The standards for quality management systems recognise that, for
certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully
verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For
this reason, sterilization processes are validated for use, the performance of the sterilization process
monitored routinely and the equipment maintained.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated
with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended
use. Attention is therefore given to a number of considerations including:
—the microbiological status of incoming raw mat
...
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