SIST EN ISO 11737-2:2010

SLOVENSKI STANDARD
SIST EN ISO 11737-2:2010
01-marec-2010
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SIST EN ISO 11737-2:2001
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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process (ISO
11737-2:2009)
Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2: Prüfungen der
Sterilität bei der Definition, Validierung und Aufrechterhaltung eines
Sterilisationsverfahrens (ISO 11737-2:2009)
Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 2: Essais de
stérilité pratiqués en cours de définition, validation et entretien d'un procédé de
stérilisation (ISO 11737-2:2009)
Ta slovenski standard je istoveten z: EN ISO 11737-2:2009
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11737-2:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11737-2:2010

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SIST EN ISO 11737-2:2010


EUROPEAN STANDARD
EN ISO 11737-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2009
ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-2:2000
English Version
Sterilization of medical devices - Microbiological methods - Part
2: Tests of sterility performed in the definition, validation and
maintenance of a sterilization process (ISO 11737-2:2009)
Stérilisation des dispositifs médicaux - Méthodes Sterilisation von Medizinprodukten - Mikrobiologische
microbiologiques - Partie 2: Contrôles de stérilité pratiqués Verfahren - Teil 2: Prüfungen der Sterilität bei der
au moment de la définition, de la validation et de la Definition, Validierung und Aufrechterhaltung eines
maintenance d'un procédé de stérilisation (ISO 11737- Sterilisationsverfahrens für Medizinprodukte (ISO 11737-
2:2009) 2:2009)
This European Standard was approved by CEN on 28 October 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 11737-2:2009: E
worldwide for CEN national Members.

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SIST EN ISO 11737-2:2010
EN ISO 11737-2:2009 (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 11737-2:2010
EN ISO 11737-2:2009 (E)
Foreword
This document (EN ISO 11737-2:2009) 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 May 2010, and conflicting national standards shall be withdrawn at the
latest by May 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 11737-2:2000.
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 Annexes ZA, ZB and ZC, 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 11737-2:2009 has been approved by CEN as a EN ISO 11737-2:2009 without any
modification.
3

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SIST EN ISO 11737-2:2010
EN ISO 11737-2:2009 (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 European Essential Requirements Qualifying remarks/Notes
Standard (ERs) of Directive 90/385/EEC
This relevant Essential Requirement
4,5,6,7,8 7
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 11737-2:2010
EN ISO 11737-2:2009 (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 European Essential Requirements
Qualifying remarks/Notes
Standard (ERs) of Directive 93/42/EEC
4,5,6,7,8 8.3 This relevant Essential Requirement
is only partly addressed in this
European Standard
This relevant Essential Requirement
4,5,6,7,8 8.4
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.

5

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SIST EN ISO 11737-2:2010
EN ISO 11737-2:2009 (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 European Essential Requirements (ERs) Qualifying remarks/Notes
Standard of Directive 98/79/EC
This relevant Essential Requirement
4,5,6,7,8 B.2.3
is only partly addressed in this
European Standard
This relevant Essential Requirement
4,5,6,7,8 B.2.4
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.


6

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SIST EN ISO 11737-2:2010

INTERNATIONAL ISO
STANDARD 11737-2
Second edition
2009-11-15


Sterilization of medical devices —
Microbiological methods —
Part 2:
Tests of sterility performed in the
definition, validation and maintenance of
a sterilization process
Stérilisation des dispositifs médicaux — Méthodes microbiologiques —
Partie 2: Essais de stérilité pratiqués au moment de la définition, de la
validation et de la maintenance d'un procédé de stérilisation





Reference number
ISO 11737-2:2009(E)
©
ISO 2009

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(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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Published in Switzerland

ii © ISO 2009 – All rights reserved

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Quality management system elements.3
4.1 Documentation .3
4.2 Management responsibility .3
4.3 Product realization .4
4.4 Measurement, analysis and improvement.4
5 Selection of product.4
5.1 General .4
5.2 Sample item portion (SIP).4
5.3 Packaging of product and sample item portions.5
6 Methods for performing tests of sterility .5
7 Assessment of method for performing tests of sterility .6
8 Maintenance of the method for performing tests of sterility .6
Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a
sterilization process.7
Bibliography.15

© ISO 2009 – All rights reserved iii

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(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 11737-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11737-2:1998) which has been technically
revised.
ISO 11737 consists of the following parts, under the general title Sterilization of medical devices —
Microbiological methods:
⎯ Part 1: Determination of a population of microorganisms on products
⎯ Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
iv © ISO 2009 – All rights reserved

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(E)
Introduction
A sterile medical device is one that is free from 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 from all
sources 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 products are non-sterile. The
purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile
products 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 sterilizing agent; 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 item 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 product item.
Generic requirements of the quality management system for design and development, production, installation
[16]
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.
International Standards specifying procedures for the development, validation and routine control of the
[1] [3]
processes used for sterilization of medical devices have been prepared (see ISO 11135-1 , ISO 11137-1 ,
[12] [7] [13] [14]
ISO 14937 , ISO 14160 , ISO 17665-1 and ISO 20857 ). An element of validation might consist of
exposing medical devices to the sterilizing agent with the extent of treatment being reduced relative to that
which will be used in routine sterilization processing, in order to provide a knowledge of the resistance to the
agent of the microbial contamination as it occurs naturally on medical devices. Subsequent to this exposure,
medical devices are subjected individually to tests of sterility as described in this part of ISO 11737. Examples
of the use of such tests are in a) establishing a dose for sterilization by radiation, and b) demonstrating the
continued validity of an established sterilization dose.
Annex A of this part of ISO 11737 gives guidance on the techniques used and on practical aspects of the
requirements.

© ISO 2009 – All rights reserved v

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SIST EN ISO 11737-2:2010

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SIST EN ISO 11737-2:2010
INTERNATIONAL STANDARD ISO 11737-2:2009(E)

Sterilization of medical devices — Microbiological methods —
Part 2:
Tests of sterility performed in the definition, validation and
maintenance of a sterilization process
1 Scope
1.1 This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have
been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine
sterilization processing. These tests are intended to be performed when defining, validating or maintaining a
sterilization process.
1.2 This part of ISO 11737 is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process;
b) performing a test for sterility (see 3.12);
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or
ISO 17665-1.
c) culturing of biological indicators or inoculated products.
[8]
NOTE 2 Guidance on culturing biological indicators is included in ISO 14161 .
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 11737-1:2006, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aerobic organism
microorganism that requires oxygen for metabolism
© ISO 2009 – All rights reserved 1

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(E)
3.2
anaerobic organism
microorganism that does not require oxygen for metabolism
3.3
bacteriostasis/fungistasis test
technical operation performed with selected microorganisms to detect the presence of substances that inhibit
the multiplication of these microorganisms in a test of sterility
3.4
bioburden
population of viable microorganisms on a product and/or a package
NOTE Adapted from ISO/TS 11139:2006, definition 2.2.
3.5
culture conditions
combination of growth media and manner of incubation used to promote germination, growth and/or
multiplication of microorganisms
NOTE The manner of incubation can include the temperature, time and any other conditions specified for incubation.
[ISO/TS 11139:2006, definition 2.10]
3.6
facultative organism
microorganism capable of both aerobic and anaerobic metabolism
3.7
growth promotion test
technical operation performed to demonstrate that a growth medium will support microbial multiplication
3.8
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other related article, intended by the manufacturer to be used, alone or in combination, for human
beings for one or more of the specific purpose(s) of:
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease;
⎯ diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
⎯ investigation, replacement, modification or support of the anatomy or of a physiological process;
⎯ supporting or sustaining life;
⎯ control of conception;
⎯ disinfection of medical devices;
⎯ providing information for medical purposes by means of in vitro examination of specimens derived from
the human body;
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.
[ISO 13485:2003, definition 3.7]
NOTE This definition from ISO 13485:2003 has been developed by the Global Harmonization Task Force (GHTF
2002).
2 © ISO 2009 – All rights reserved

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(E)
3.9
product
result of a process
NOTE 1 For the purposes of sterilization standards, product is tangible and can be raw material(s), intermediate(s),
sub-assembly(ies) and health care product(s).
NOTE 2 Adapted from ISO 9000:2005, definition 3.4.2.
3.10
sample item portion
SIP
defined part of a medical device that is tested
3.11
sterile
free from viable microorganisms
[ISO/TS 11139:2006, definition 2.43]
3.12
test for sterility
technical operation defined in a Pharmacopoeia, performed on product following exposure to a sterilization
process
[ISO/TS 11139:2006, definition 2.53]
3.13
test of sterility
technical operation performed as part of development, validation or requalification to determine the presence
or absence of viable microorganisms on product or portions thereof
[ISO/TS 11139:2006, definition 2.54]
4 Quality management system elements
4.1 Documentation
4.1.1 Procedures for the performance of tests of sterility shall be specified.
4.1.2 Documents and records required by this part of ISO 11737 shall be reviewed and approved by
designated personnel (see 4.2.1). Documents and records shall be controlled in accordance with ISO 13485
or ISO/IEC 17025. Records retained shall include all original observations, calculations, derived data and final
reports. The records shall include the identity of all personnel involved in sampling, preparation and testing.
4.1.3 Calculations and data transfers shall be subjected to appropriate verification.
4.2 Management responsibility
4.2.1 The responsibility and authority for implementing and performing the procedures described in this part
of ISO 11737 shall be specified. Responsibility shall be assigned to competent personnel in accordance with
ISO 13485 or ISO/IEC 17025.
4.2.2 If the requirements of this part of ISO 11737 are undertaken by organizations with separate quality
management systems, the responsibility and authority of each party shall be specified.
4.2.3 All equipment required for correct performance of the specified tests and measurements shall be
available.
© ISO 2009 – All rights reserved 3

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SIST EN ISO 11737-2:2010
ISO 11737-2:2009(E)
4.3 Product realization
4.3.1 Procedures for purchasing shall be specified. These procedures shall comply with ISO 13485 or
ISO/IEC 17025.
4.3.2 A documented system complying with ISO 13485, ISO/IEC 17025 or ISO 10012 shall be specified for
the calibration of all equipment, including instrumentation for test purposes, used in meeting the requirements
of this part of ISO 11737.
4.3.3 Equipment or parts thereof that come into contact with product, eluent or media during testing shall be
sterile.
4.3.4 Methods shall be specified for the preparation and sterilization of materials used in the tests of sterility,
including appropriate quality tests.
4.4 Measurement, analysis and improvement
Procedures for investigation of unusual, unexpected or out-of-specification results and for correction,
corrective action and preventive action shall be specified. These procedures shall comply with ISO 13485 or
ISO/IEC 17025.
5 Selection of product
5.1 General
5.1.1 The procedures for selection and handling of product for performing tests of sterility shall ensure that
product is representative of routine production, including packaging materials and processes. (See also 5.3.)
5.1.2 If product is grouped for the purposes of development, validation and routine control of the sterilization
process in which tests of sterility are performed, the rationale for inclusion of a product within a group shall be
recorded (see 4.1.2). The rationale shall include criteria to ensure that product selected for testing is
representative of the whole group.
5.2 Sample item portion (SIP)
5.2.1 If allowed in an applicable standard, for the devel
...