SIST EN ISO 14937:2010

SLOVENSKI STANDARD
SIST EN ISO 14937:2010
01-januar-2010
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SIST EN ISO 14937:2001
SIST EN ISO 14937:2001/AC:2004
SIST EN ISO 14937:2001/AC:2005
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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 (ISO 14937:2009)
Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an
die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung
und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO
14937:2009)
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un
agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un
processus de stérilisation pour dispositifs médicaux (ISO 14937:2009)
Ta slovenski standard je istoveten z: EN ISO 14937:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 14937:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14937:2010

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SIST EN ISO 14937:2010


EUROPEAN STANDARD
EN ISO 14937

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2009
ICS 11.080.01 Supersedes EN ISO 14937:2000
English Version
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 (ISO 14937:2009)
Stérilisation des produits de santé - Exigences générales Sterilisation von Produkten für die Gesundheitsfürsorge -
pour la caractérisation d'un agent stérilisant et pour la mise Allgemeine Anforderungen an die Charakterisierung eines
au point, la validation et la vérification de routine d'un sterilisierenden Agens und an die Entwicklung, Validierung
processus de stérilisation pour dispositifs médicaux (ISO und Lenkung der Anwendung eines Sterilisationsverfahrens
14937:2009) für Medizinprodukte (ISO 14937:2009)
This European Standard was approved by CEN on 24 September 2009.

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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14937:2009: E
worldwide for CEN national Members.

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SIST EN ISO 14937:2010
EN ISO 14937:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

2

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SIST EN ISO 14937:2010
EN ISO 14937:2009 (E)
Foreword
This document (EN ISO 14937:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 2010.
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 EN ISO 14937:2000.
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 Directives.
For relationship with EU Directives, see informative Annex ZA, B and C, 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, 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 the United Kingdom.
Endorsement notice
The text of ISO 14937:2009 has been approved by CEN as a EN ISO 14937:2009 without any modification.
3

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SIST EN ISO 14937:2010
EN ISO 14937:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable 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 90/385/EEC on active implantable medical devices.
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 corresponding 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
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
4

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SIST EN ISO 14937:2010
EN ISO 14937:2009 (E)
Annex ZB
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on 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 on medical devices.
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 corresponding 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 93/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 8.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
5

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SIST EN ISO 14937:2010
EN ISO 14937:2009 (E)
Annex ZC
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic 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 98/79/EC on in vitro diagnostic medical devices.
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 ZC.1 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 ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 2.3 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 2.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

6

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SIST EN ISO 14937:2010

INTERNATIONAL ISO
STANDARD 14937
Second edition
2009-10-15


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
Stérilisation des produits de santé — Exigences générales pour la
caractérisation d'un agent stérilisant et pour la mise au point, la
validation et la vérification de routine d'un processus de stérilisation
pour dispositifs médicaux





Reference number
ISO 14937:2009(E)
©
ISO 2009

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SIST EN ISO 14937:2010
ISO 14937:2009(E)
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2009 – All rights reserved

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SIST EN ISO 14937:2010
ISO 14937:2009(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 .2
4 Quality management system elements.7
4.1 Documentation .7
4.2 Management responsibility .7
4.3 Product realization .8
4.4 Measurement, analysis and improvement — Control of non-conforming product.8
5 Sterilizing agent characterization .8
5.1 General .8
5.2 Sterilizing agent.8
5.3 Microbicidal effectiveness.8
5.4 Effects on materials .9
5.5 Safety and the environment .9
6 Process and equipment characterization .9
6.1 General .9
6.2 Process characterization.9
6.3 Equipment characterization .10
7 Product definition.10
8 Process definition .11
9 Validation.12
9.1 General .12
9.2 Installation qualification .12
9.3 Operational qualification .13
9.4 Performance qualification .13
9.5 Review and approval of validation .14
10 Routine monitoring and control.14
11 Product release from sterilization .14
12 Maintaining process effectiveness.15
12.1 General .15
12.2 Recalibration.15
12.3 Maintenance of equipment .15
12.4 Requalification.15
12.5 Assessment of change .15
Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating
microbicidal effectiveness.16
Annex B (normative) Approach 1 — Process definition based on inactivation of the microbial
population in its natural state .18
Annex C (normative) Approach 2 — Process definition based on inactivation of reference
microorganisms and knowledge of bioburden .19
© ISO 2009 – All rights reserved iii

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SIST EN ISO 14937:2010
ISO 14937:2009(E)
Annex D (normative) Approach 3 — Conservative process definition based on inactivation of
reference microorganisms.20
Annex E (informative) Guidance on application of this International Standard .22
Bibliography .36

iv © ISO 2009 – All rights reserved

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SIST EN ISO 14937:2010
ISO 14937:2009(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 14937 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 14937:2000) and ISO 14937:2000/Cor.1:2003
which have been technically revised.
© ISO 2009 – All rights reserved v

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SIST EN ISO 14937:2010
ISO 14937:2009(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) could, 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 generally can best be described by an exponential relationship between the number
of microorganisms surviving and the extent of treatment with the sterilizing agent; 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.
This International Standard describes requirements that, if met, will provide a sterilization process with
appropriate microbicidal activity intended to sterilize medical devices. Furthermore, compliance with the
requirements ensures that the sterilization process is both reliable and reproducible so that predictions can be
made, with reasonable confidence, that there is a low level of probability of there being a viable
microorganism present on a medical device after sterilization. Specification of 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 system 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, 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 is monitored
routinely and the equipment is maintained.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated
with the provision of reliable assurance that a processed medical device is sterile and, in this regard, suitable
for its intended use. Attention is also given to a number of factors 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 medical device;
c) the control of the environment in which the medical device is manufactured, 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 medical device is packaged;
g) the conditions under which the medical device is stored.
vi © ISO 2009 – All rights reserved

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SIST EN ISO 14937:2010
ISO 14937:2009(E)
The type of contamination on a medical device to be sterilized varies, and this influences the effectiveness of
a sterilization process. Medical devices that have been used in a health care setting and that are being
presented for resterilization in accordance with the manufacturer's instructions (see ISO 17664) should be
regarded as special cases. There is the potential for such medical devices 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, particular attention has to be given to the validation and control of the cleaning
and disinfection processes used during reprocessing.
The requirements are the normative parts of this International Standard with which compliance is claimed. The
guidance given in Annex E is not normative and is not provided as a checklist for auditors. The guidance
provides explanations and methods that are regarded as being a suitable means for complying with the
requirements. Methods other than those given in the guidance can be used if they are effective in achieving
compliance with the requirements of this International Standard.
The development, validation and routine control of a sterilization process comprise a number of discrete but
interrelated activities, for example, calibration, maintenance, product definition, process definition, installation
qualification, operational qualification and performance qualification. While the activities required by this
International Standard have been grouped together and are presented in a particular order, this International
Standard does not require that the activities be performed in the order that they are presented. The activities
required are not necessarily sequential, as the programme of development and validation can be iterative. The
responsibility for carrying out the activities required by this International Standard will vary from case to case.
This International Standard requires that the responsibilities of the various parties be defined (see 4.2) but
does not specify to whom the responsibilities are allocated. Annex E provides guidance on allocation of
responsibility.
This International Standard has three distinct applications:
⎯ for manufacturers of health care products who wish to apply to their products a sterilization process for
which a specific International Standard does not exist;
⎯ for manufacturers and users of sterilization processes in health care settings for which a specific
International Standard does not exist;
⎯ as a framework for the preparation or revision of standards for specific sterilization processes.

© ISO 2009 – All rights reserved vii

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SIST EN ISO 14937:2010

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SIST EN ISO 14937:2010
INTERNATIONAL STANDARD ISO 14937:2009(E)

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
1 Scope
1.1 Inclusions
1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing
agent and for the development, validation and routine monitoring and control of a sterilization process for
medical devices.
NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified
herein can also be applied to sterilization processes for other health care products.
1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated
by physical and/or chemical means.
1.1.3 This International Standard is intended to be applied by process developers, manufacturers of
sterilization equipment, manufacturers of medical devices t
...