SIST 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)
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)
This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11135-1:2007)
Dieser Teil von ISO 11135 legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens mit Ethylenoxid für Medizinprodukte fest.
ANMERKUNG 1 Obgleich der Anwendungsbereich dieses Teils von ISO 11135 auf Medizinprodukte begrenzt ist, legt er Anforderungen fest und liefert Anleitungen, die für andere Produkte für die Gesundheitsfürsorge gelten können.
Es sollte nicht vorausgesetzt werden, dass entsprechend den Anforderungen von diesem Teil von ISO 11135 validierte und gelenkte Sterilisationsverfahren bei der Inaktivierung der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt Jakob Krankheit wirksam sind. In bestimmten Ländern sind spezifische Empfehlungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet worden.
ANMERKUNG 2 Siehe zum Beispiel ISO 22442 1, ISO 22442 2 und ISO 22442 3.
Dieser Teil von ISO 11135 legt keine in den Einzelheiten festgelegte Anforderung zur Bezeichnung eines Medizinprodukts als steril fest.
ANMERKUNG 3 Zu beachten sind nationale oder regionale Anforderungen für die Bezeichnung von Medizinprodukten als „steril“. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
Dieser Teil von ISO 11135 legt kein Qualitätsmanagementsystem für die Überwachung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG 4 Für die Entwicklung, Validierung und Lenkung der Anwendung von Sterilisationsverfahren für Medizin¬produkte ist die effektive Durchführung definierter und dokumentierter Verfahren notwendig. Diese Verfahren sind im Allgemeinen Elemente eines Qualitätsmanagementsystems. Es ist keine Anforderung dieses Teils von ISO 11135, dass während der Herstellung oder Wiederaufbereitung ein vollständiges Qualitätsmanagementsystem vorzuliegen hat, aber die als Minimum erforderlichen Elemente eines Qualitätsmanagementsystems zur Lenkung der Anwendung des Sterilisations¬verfahrens werden an geeigneten Stellen
Stérilisation des produits de santé - Oxyde d'éthylene - Partie 1: Exigences de développement, de validation et contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux (ISO 11135-1:2007)
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - 1. del: Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 11135-1:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11135-1:2007
01-oktober-2007
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR(WLOHQRNVLGGHO =DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH ,62
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)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 11135-1:2007)
Stérilisation des produits de santé - Oxyde d'éthylene - Partie 1: Exigences de
développement, de validation et contrôle de routine d'un processus de stérilisation pour
des dispositifs médicaux (ISO 11135-1:2007)
Ta slovenski standard je istoveten z: EN ISO 11135-1:2007
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11135-1:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 11135-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2007
ICS 11.080.01 Supersedes EN 550:1994
English Version
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)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences de développement, de validation et de Ethylenoxid - Teil 1: Anforderungen an die Entwicklung,
contrôle de routine d'un processus de stérilisation pour des Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 11135-1:2007) Sterilisationsverfahrens für Medizinprodukte (ISO
11135:2007)
This European Standard was approved by CEN on 13 April 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11135-1:2007: E
worldwide for CEN national Members.
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EN ISO 11135-1:2007 (E)
Foreword
This document (EN ISO 11135-1:2007) 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 November 2007, and conflicting national
standards shall be withdrawn at the latest by May 2010.
This document supersedes EN 550:1994.
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, which is an integral part 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, 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.
Endorsement notice
The text of ISO 11135-1:2007 has been approved by CEN as EN ISO 11135-1:2007 without any
modifications.
2
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EN ISO 11135-1:2007 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC Medical devices.
Once this standard is cited in the Official Journal of the European Communities 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 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Medical devices
Clause(s)/Sub- Essential Essential Essential Qualifying
clause(s) of this Requirements Requirements Requirements (ERs) remarks/Notes
EN (ERs) of Directive (ERs) of Directive of Directive
90/385/EEC 93/42/EEC 98/79/EC
In part
4,5,6,7,8,9,10,11,12 7 8.3 B.2.3
In part
4,5,6,7,8,9,10,11,12 8.4 B.2.4
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
3
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INTERNATIONAL ISO
STANDARD 11135-1
First edition
2007-05-01
Sterilization of health care products —
Ethylene oxide —
Part 1:
Requirements for development, validation
and routine control of a sterilization
process for medical devices
Stérilisation des produits de santé — Oxyde d'éthylène —
Partie 1: Exigences de développement, de validation et de contrôle de
routine d'un processus de stérilisation pour des dispositifs médicaux
Reference number
ISO 11135-1:2007(E)
©
ISO 2007
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ISO 11135-1:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 11135-1:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management systems . 9
4.1 Documentation. 9
4.2 Management responsibility . 9
4.3 Product realization. 9
4.4 Measurement, analysis and improvement — Control of nonconforming product . 10
5 Sterilizing agent characterization . 10
5.1 Sterilizing agent . 10
5.2 Microbicidal effectiveness . 10
5.3 Material effects. 10
5.4 Environmental considerations . 10
6 Process and equipment characterization . 10
6.1 Process characterization . 10
6.2 Equipment characterization. 11
7 Product definition . 12
7.1 General. 12
7.2 Product safety and performance. 12
7.3 Microbiological quality. 12
7.4 Documentation. 13
8 Process definition. 13
9 Validation. 14
9.1 Installation qualification. 14
9.2 Operational qualification. 14
9.3 Performance qualification. 14
9.4 Varying load configurations . 16
9.5 Review and approval of validation. 16
10 Routine monitoring and control . 18
11 Product release from sterilization. 19
12 Maintaining process effectiveness . 19
12.1 General. 19
12.2 Maintenance of equipment . 19
12.3 Requalification . 19
12.4 Assessment of change. 20
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach. 21
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach. 23
Annex C (informative) General guidance. 25
Bibliography . 41
© ISO 2007 – All rights reserved iii
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ISO 11135-1:2007(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.
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.
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.
ISO 11135-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 11135 consists of the following parts, under the general title Sterilization of health care products —
Ethylene oxide:
⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical
devices
⎯ Part 2: Guidance on the application of ISO 11135-1
For the purposes of this part of ISO 11135 the CEN annex regarding fulfilment of European Council Directives
will be removed at publication stage.
iv © ISO 2007 – All rights reserved
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ISO 11135-1:2007(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. International Standards that specify
requirements for validation and routine control of sterilization processes, require, when it is necessary to
supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to
sterilization be minimized. Even so, 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; 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.
This part of 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 this activity is both reliable and reproducible so that it can be predicted,
with reasonable confidence, that there is a low level of probability of there being a viable microorganism
present on product after sterilization. Specification of 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:
a) the microbiological status of incoming raw materials and/or components;
b) the validation and routine control of any cleaning and disinfection procedures used on the product;
c) the control of the environment in which the product is manufactured or reprocessed, assembled and
packaged;
d) the control of equipment and processes;
e) the control of personnel and their hygiene;
f) the manner and materials in which the product is packaged;
g) the conditions under which product is stored.
© ISO 2007 – All rights reserved v
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ISO 11135-1:2007(E)
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) should be regarded as 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.
The requirements are the normative parts of this part 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 provides explanations and methods that are regarded as being suitable means for complying with
the requirements. Methods other than those given in the guidance may be used if they are effective in
achieving compliance with the requirements of this part 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 this part
of ISO 11135 have been grouped together and are presented in a particular order, this part of 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 part of ISO 11135 does not specify the
particular individuals or organizations to carry out the activities.
When determining the suitability of ethylene oxide (EO) for sterilization of medical devices, it is important that
patient safety is addressed by minimizing exposure to residual EO, ethylene chlorohydrin (ECH) and ethylene
glycol (EG) during normal product use (see ISO 10993-7).
vi © ISO 2007 – All rights reserved
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INTERNATIONAL STANDARD ISO 11135-1:2007(E)
Sterilization of health care products — Ethylene oxide —
Part 1:
Requirements for development, validation and routine control
of a sterilization process for medical devices
1 Scope
This part of ISO 11135 specifies requirements for the development, validation and routine control of an
ethylene oxide sterilization process for medical devices.
NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other health care products.
Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135
are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as
scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have
been produced in particular countries for the processing of materials potentially contaminated with these
agents.
NOTE 2 See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3.
This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile.
NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for
example EN 556-1 or ANSI/AAMI ST67.
This part of ISO 11135 does not specify a quality management system for the control of all stages of
production of medical devices.
NOTE 4 The effective implementation of defined and documented procedures is necessary for the development,
validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to
be elements of a quality management system. It is not a requirement of this part of ISO 11135 to have a complete quality
management system during manufacture or reprocessing, but the elements of a quality management system that are the
minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see in
particular Clause 4). National and/or regional regulations for the provision of medical devices might require implementation
of a complete quality management system and the assessment of that system by a third party.
This part of ISO 11135 does not specify requirements for occupational safety associated with the design and
operation of ethylene oxide sterilization facilities.
NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may also
exist.
NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some
countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used.
This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene
oxide directly into individual product packages, or continuous sterilization processes.
© ISO 2007 – All rights reserved 1
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ISO 11135-1:2007(E)
This part of ISO 11135 does not cover analytical methods for determining levels of residual ethylene oxide
and/or its reaction products.
NOTE 7 For further information see ISO 10993-7.
NOTE 8 Attention is drawn to the possible existence of regulations specifying limits for the level of ethylene oxide
residues present on or in medical devices and products.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 10012, Measurement management systems — Requirements for measurement processes and measuring
equipment
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General
requirements
ISO 11138-2:2006, Sterilization of health care products — Biological indicators — Part 2: Biological indicators
for ethylene oxide sterilization processes
ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population
of microorganisms on products
ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in
the validation of a sterilization process
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14161, Sterilization of health care products — Biological indicators — Guidance for the selection, use and
interpretation of results
ISO 14937:2000, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aeration
part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the
medical device until predetermined levels are reached
NOTE This may be performed within the sterilizer and/or in a separate chamber or room.
2 © ISO 2007 – All rights reserved
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ISO 11135-1:2007(E)
3.2
aeration area
either a chamber or a room in which aeration occurs
3.3
bioburden
population of viable microorganisms on or in the product and/or sterile barrier system
[ISO/TS 11139:2006, definition 2.2]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
[ISO/TS 11139:2006, definition 2.3]
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity
indicated by a measuring instrument or measuring system, or values represented by a material measure or a
reference material, and the corresponding values realized by standards
[VIM:1993, definition 6.11]
3.6
chemical indicator
test sys
...
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