SIST EN ISO 11737-2:2020
(Main)Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
EN-ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been 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. This document 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. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products.
Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren - Teil 2: Prüfungen der Sterilität bei der Definition, Validierung und Aufrechterhaltung eines Sterilisationsverfahrens (ISO 11737-2:2019)
1.1 Dieses Dokument legt die allgemeinen Kriterien für Prüfungen der Sterilität von Medizinprodukten fest, die einer Behandlung mit dem sterilisierenden Agens unterzogen wurden, die im Vergleich zu derjenigen, die voraussichtlich bei routinemäßigen Sterilisationsverfahren angewendet wird, reduziert wurde. Diese Prüfungen sind vorgesehen, wenn ein Sterilisationsverfahren definiert, validiert oder aufrechterhalten wird.
1.2 Dieses Dokument gilt nicht für:
a) die Sterilitätsprüfung für die Routinefreigabe eines Produkts, das einem Sterilisationsverfahren unterzogen wurde;
b) das Durchführen einer Prüfung auf Sterilität (siehe 3.14);
ANMERKUNG 1 Die Durchführung von a) oder b) ist keine Anforderung von ISO 11135, ISO 11137 1, ISO 11137 2, ISO 14160, ISO 14937, ISO 17665 1 oder ISO 20857.
c) Prüfung der Sterilität oder Prüfung auf Sterilität zum Nachweis der Haltbarkeitsdauer und Stabilität des Produkts und/oder der Unversehrtheit der Verpackung; und
d) die Kultivierung biologischer Indikatoren oder beimpfter Produkte.
ANMERKUNG 2 Ein Leitfaden über die Kultivierung biologischer Indikatoren ist in ISO 11138 7 enthalten
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation (ISO 11737-2:2019)
1.1 Le présent document spécifie les critères généraux pour les contrôles de stérilité des dispositifs médicaux qui ont été exposés à un traitement par un agent stérilisant, d'une plus faible ampleur que celui qu'il est prévu d'utiliser dans le procédé de stérilisation de routine. Les essais décrits sont destinés à être réalisés au moment de la définition, de la validation ou de la maintenance d'un procédé de stérilisation.
Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 2. del: Preskusi sterilnosti pri definiciji, validaciji in vzdrževanju sterilizacijskih postopkov (ISO 11737-2:2019)
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Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11737-2:2020
01-julij-2020
Nadomešča:
SIST EN ISO 11737-2:2010
Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 2. del:
Preskusi sterilnosti pri definiciji, validaciji in vzdrževanju sterilizacijskih
postopkov (ISO 11737-2:2019)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process (ISO
11737-2:2019)
Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren -
Teil 2: Prüfungen der Sterilität bei der Definition, Validierung und Aufrechterhaltung eines
Sterilisationsverfahrens (ISO 11737-2:2019)
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2: Contrôles de
stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un
procédé de stérilisation (ISO 11737-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11737-2:2020
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11737-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11737-2:2020
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SIST EN ISO 11737-2:2020
EN ISO 11737-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-2:2009
English Version
Sterilization of health care products - Microbiological
methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization
process (ISO 11737-2:2019)
Stérilisation des produits de santé - Méthodes Sterilisation von Produkten für die
microbiologiques - Partie 2: Contrôles de stérilité Gesundheitsfürsorge - Mikrobiologische Verfahren -
pratiqués au moment de la définition, de la validation Teil 2: Prüfungen der Sterilität bei der Definition,
et de la maintenance d'un procédé de stérilisation (ISO Validierung und Aufrechterhaltung eines
11737-2:2019) Sterilisationsverfahrens (ISO 11737-2:2019)
This European Standard was approved by CEN on 29 April 2020.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11737-2:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Contents Page
European 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
[OJ L 189] aimed to be covered . 4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be
covered. 6
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L
331] aimed to be covered . 8
Annex ZD (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 10
Annex ZE (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 12
2
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
European foreword
This document (EN ISO 11737-2:2020) 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 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11737-2:2009, with a revised European Foreword and European
Annexes ZA, ZB and ZC, and additional European Annexes ZD and ZE.
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 the relationship with EU Directive(s) see informative Annex ZA, ZB, ZC, ZD and ZE which are 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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11737-2:2019 has been approved by CEN as EN ISO 11737-2:2020 without any
modification.
3
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical
devices [OJ L 189] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/023 to
provide one voluntary means of conforming to essential requirements of Council Directive 90/385/EEC
of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable
medical devices [OJ L 189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 4, 5, 8, 9 and 10of the Directive.
NOTE 3 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
4
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
90/385/EEC [OJ L 189]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 90/385/EEC
7 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices.
This relevant Essential Requirement
is only partly addressed in this
European Standard and only in
conjunction with the applicable
standard for validation and routine
control of the sterilization process
being employed. Design and
packaging for maintenance of
sterility during transportation and
storage are not covered. Aspects of
manufacture other than those
related to the use of a test of sterility
in the definition, validation or
maintenance of a sterilization
process are not covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
5
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169]
aimed to be covered
This European Standard has been prepared under a Commission's standardization request M/023 to
provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC
of 14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this
European Standard.
6
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Table ZB.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 93/42/EEC
8.3 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices.
This relevant Essential Requirement
is only partly addressed in this
European Standard and only in
conjunction with the applicable
standard for validation and routine
control of the sterilization process
being employed. Design and
packaging for maintenance of
sterility during transportation and
storage are not covered. Aspects of
manufacture other than those
related to the use of a test of sterility
in definition, validation or
maintenance of a sterilization
process are not covered.
8.4 4,5,6,7,8 This relevant Essential Requirement
is addressed only in regards to the
use of a test of sterility in the
definition, validation or
maintenance of a sterilization
process for the device. Aspects of
manufacture other than those
related to the use of a test of sterility
in the definition, validation or
maintenance of a sterilization
process are not covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
7
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (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 [OJ L 331] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request, M/252,
concerning the development of European standards relating to in vitro diagnostic medical devices, to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [OJ L
331].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 98/79/EC. This means that risks have to be reduced ‘as far
as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of
the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7of the Directive.
NOTE 3 When an Essential Requirement does not appear in Table ZC.1, it means that it is not addressed by this
European Standard.
8
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Table ZC.1 — Correspondence between this European Standard and Annex I of Directive
98/79/EC [OJ L 331]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 98/79/EC
B.2.3 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices.
This relevant Essential Requirement
is only partly addressed in this
European Standard and only in
conjunction with the applicable
standard for validation and routine
control of the sterilization process
being employed. Design and
packaging for maintenance of
sterility during transportation and
storage are not covered. Aspects of
manufacture other than those
related to use of a test of sterility in
the definition, validation or
maintenance of a sterilization
process are not covered.
B.2.4 4,5,6,7,8 This relevant Essential Requirement
is addressed only in regards to the
use of a test of sterility in the
definition, validation or
maintenance of a sterilization
process for the device.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
9
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Annex ZD
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZD.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZD.1, it means that it is
not addressed by this European Standard.
Table ZD.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Remarks / Notes
Requirements of Regulation
of this EN
(EU) 2017/745
11.3 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices. It
could also be applied in the
development, validation and
routine control of a process for
attainment of a specific microbial
state other than sterility.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for
maintenance of a specific
microbial state during
transportation and storage are not
10
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
covered. Aspects of manufacture
other than those related use of a
test of sterility in attainment of a
specific microbial state are not
covered.
11.4 first sentence only 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to use of a
test of sterility in definition,
validation and maintenance of a
sterilization process are not
covered. Evidence that the
integrity of the packaging is
maintained to the point of use is
not covered.
11.5 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of sterility are not
covered. Aspects of manufacture
other than those related to use of a
test of sterility in definition,
validation and maintenance of a
sterilization process are not
covered.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
11
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Annex ZE
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/746 of 5 April 2017 concerning in vitro diagnostic medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZE.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZE.1, it means that it is
not addressed by this European Standard.
Table ZE.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/746 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Remarks / Notes
Requirements of Regulation
of this EN
(EU) 2017/746
11.2 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices. It
could also be applied to the
development or validation of a
process for attainment of a specific
microbial state other than sterility.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for
maintenance of a sterility or
another specific microbial state
during transportation and storage
are not covered. Aspects of
12
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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
manufacture other than those
related use of a test of sterility in
attainment of a specific microbial
state are not covered
11.3 4,5,6,7,8 This standard addresses the
performance of tests of sterility in
the definition, validation and
maintenance of a sterilization
process for medical devices.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for
maintenance of sterility are not
covered. Aspects of manufacture
other than those related to use of a
test of sterility in definition,
validation and maintenance of a
sterilization process are not
covered.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
13
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SIST EN ISO 11737-2:2020
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SIST EN ISO 11737-2:2020
INTERNATIONAL ISO
STANDARD 11737-2
Third edition
2019-12
Sterilization of health care products —
Microbiological methods —
Part 2:
Tests of sterility performed in
the definition, validation and
maintenance of a sterilization process
Stérilisation des produits de santé — Méthodes microbiologiques —
Partie 2: Contrôles de stérilité pratiqués au moment de la définition,
de la validation et de la maintenance d'un procédé de stérilisation
Reference number
ISO 11737-2:2019(E)
©
ISO 2019
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SIST EN ISO 11737-2:2020
ISO 11737-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 11737-2:2020
ISO 11737-2:2019(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 3
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 o
...
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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/DIS 11737-2:2018)
Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2: Prüfungen der
Sterilität bei der Definition, Validierung und Aufrechterhaltung eines
Sterilisationsverfahrens (ISO/DIS 11737-2:2018)
Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 2: Contrôles
de stérilité pratiqués au moment de la définition, de la validation et de la maintenance
d'un procédé de stérilisation (ISO/DIS 11737-2:2018)
Ta slovenski standard je istoveten z: prEN ISO 11737-2
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11737-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11737-2:2018
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oSIST prEN ISO 11737-2:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11737-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-06-06 2018-08-29
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: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance
d'un procédé de stérilisation
ICS: 11.080.01; 07.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11737-2:2018(E)
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. ISO 2018
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oSIST prEN ISO 11737-2:2018
ISO/DIS 11737-2:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2018 – All rights reserved
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oSIST prEN ISO 11737-2:2018
ISO/DIS 11737-2:2018(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality management system elements . 4
4.1 Documentation . 4
4.2 Management responsibility . 4
4.3 Product realization . 4
4.4 Measurement, analysis and improvement . 4
5 Selection of product . 5
5.1 General . 5
5.2 Sample item portion (SIP) . 5
5.3 Packaging of product and sample item portions . 6
6 Methods for performing tests of sterility. 6
7 Assessment of method for performing tests of sterility . 7
8 Maintenance of the method for performing tests of sterility. 7
Annex A (informative) Guidance on tests of sterility performed in validation and
maintenance of a sterilization process . 8
Annex B (informative) Typical assignment of responsibilities .17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices
[OJ L 189] aimed to be covered .19
Bibliography .21
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oSIST prEN ISO 11737-2:2018
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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 (see 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 (see 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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This third edition cancels and replaces the second edition (ISO 11737-2:2009), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— addition of a requirement concerning the test samples and the interval of time between the
manufacture of product and the exposure to the sterilizing agent being reflective of routine
manufacturing;
— addition of a requirement about the samples staying immersed in the media and providing a
rationale where this is not possible;
— addition of a requirement regarding tests where microorganisms are eluted from product for the
test of sterility, to address a risk assessment to determine the appropriateness of the removal
process and well as stating that it has to be demonstrated that all microorganisms are recoverable
using this method;
— provision of additional guidance regarding performing tests of sterility on packaging, clarifying
that package testing is not typically done except when it is an integral part of the product;
— provision of additional guidance regarding what is meant by “controlled environment” for
performing tests of sterility;
— provision of additional guidance to discuss circumstances where the method suitability test does
not give acceptable results, stating that after multiple attempts to eliminate inhibitory substances,
it is appropriate to accept a reduction of inhibitory substances, with an accompanying rationale and
risk assessment;
— provision of guidance regarding identification of microbial growth in a test of sterility, saying
generally for positive growth the microorganism(s) should be identified;
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— provision of guidance regarding method suitability, saying that consideration should be given to
periodically demonstrating ongoing method suitability in order to ensure that an accumulation of
minor changes over time has not occurred;
— addition of a table to clarify where typical responsibilities reside for the manufacturer or the
laboratory.
A list of all parts in the ISO 11737 series can be found on the ISO website.
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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. 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,
[16]
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.
International Standards specifying procedures for the development, validation and routine control
[1]
of the processes used for sterilization of medical devices have been prepared (see ISO 11135,
[2] [11] [7] [12] [13]
ISO 11137-1, 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 document. 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 document gives guidance on the techniques used and on practical aspects of the
requirements.
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oSIST prEN ISO 11737-2:2018
DRAFT INTERNATIONAL STANDARD ISO/DIS 11737-2:2018(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 document 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 document 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), and
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937,
ISO 17665-1 or ISO 20857.
c) culturing of biological indicators or inoculated products.
[5]
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7 .
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 11737-1:2018, Sterilization of health care products — Microbiological methods — Part 1: Determination
of a population of microorganisms on products
ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 15189:2012, Medical laboratories — Requirements for quality and competence
ISO/IEC 17025:2017, 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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
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— ISO Online browsing platform: available at http: //www .iso .org/obp
3.1
aerobic organism
microorganism that requires oxygen for metabolism
3.2
anaerobic organism
microorganism that does not require oxygen for metabolism
3.3
bacteriostasis/fungistasis test
technical operation performed to detect the presence of substances that inhibit microbial multiplication
[SOURCE: ISO 11139:201X, 3.20]
3.4
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO 11139:201X, 3.23]
3.5
culture conditions
combination of growth media and manner of incubation used to promote germination, growth and/or
multiplication of microorganisms
Note 1 to entry: The manner of incubation can include the temperature, time, and any other conditions specified
for incubation.
[SOURCE: ISO 11139:201X, 3.69]
3.6
facultative organism
microorganism capable of both aerobic and anaerobic metabolism
[SOURCE: ISO 11139:201X, 3.113]
3.7
growth promotion test
technical operation performed to demonstrate that a growth medium will support microbial
multiplication
[SOURCE: ISO 11139:201X, 3.127]
3.8
health care product
medical device, including in vitro diagnostic medical device, or medicinal product, including
biopharmaceutical
[SOURCE: ISO 11139:201X, 3.131]
3.9
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or , software
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical 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;
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— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions, but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in the Note 1 to entry have
been added]
3.10
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), health care product(s).
[SOURCE: ISO 11139:201X, 3.216]
3.11
sample item portion
SIP
specified part of a health care product that is tested
[SOURCE: ISO 11139:201X, 3.239]
3.12
sterile
free from viable microorganisms
[SOURCE: ISO 11139:201X, 3.270]
3.13
test for sterility
technical operation specified in a pharmacopoeia performed on product following an aseptic process or
exposure to a sterilization process
[SOURCE: ISO 11139:201X, 3.298]
3.14
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
[SOURCE: ISO 11139:201X, 3.299]
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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 document shall be reviewed and approved by designated
personnel (see 4.2.1). Documents and records shall be controlled in accordance with applicable
standards (e.g. ISO 13485, ISO/IEC 17025, or ISO 15189). 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 document shall be specified. Responsibility shall be assigned to competent personnel in accordance
with applicable standards (e.g. ISO 13485, ISO/IEC 17025, or ISO 15189).
4.2.2 If the requirements of this document 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.
4.3 Product realization
4.3.1 Procedures for purchasing shall be specified. These procedures shall comply with applicable
standards (e.g. ISO 13485, ISO/IEC 17025, or ISO 15189).
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 document.
4.3.3 Equipment or parts thereof or materials that come into contact with product 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
For the purpose of tests of sterility and results, measurement uncertainty, precision and bias do
not apply and therefore this type of data analysis is not necessary, except in evaluating the overall
competency of the laboratory.
Procedures for investigation of unusual or unexpected results, results not meeting acceptance criteria,
and for correction, corrective action or preventive action should be specified. These procedures shall
comply with applicable standards (e.g. ISO 13485, ISO/IEC 17025, or ISO 15189).
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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.
5.1.3 The interval of time between the manufacture of product and the exposure to the sterilizing
agent shall be reflective of routine manufacturing.
5.1.4 The rationale for the number of product items that are selected and the number of batches from
which this selection is made shall be documented (see 5.1.2).
NOTE This might be described in the relevant International Standard specifying the requirements for
validation and routine control of the sterilization process.
5.2 Sample item portion (SIP)
5.2.1 Whenever practicable the test of sterility is performed on the entire product. A selected portion
of the product [sample item portion (SIP)] may be substituted for the entire product in the test of sterility
when permitted in the applicable sterilization standard.
5.2.2 The determination of portions selected for tests of sterility shall be based on whether the
bioburden is known to be evenly distributed (see 5.2.2.1) or not known to be evenly distributed (see
5.2.2.2).
5.2.2.1 When the bioburden distribution is known, it applies that
a) if the bioburden is evenly distributed on and/or in the item, the SIP for tests of sterility may be
selected from any portion of the item;
b) if the bioburden is not evenly distributed, the SIP for tests of sterility shall include either:
1) portions of product selected that proportionally represent each of the materials from which
the product is made, or
2) the portion of the product which contains the most severe microbial challenge (numbers and/
or types) to the sterilization process.
When selecting the portion which contains the most severe microbial challenge, the relationship of the
bioburden of the SIP tested to the entire product bioburden should be established.
5.2.2.2 If the bioburden distribution is not known, the SIP for tests of sterility shall consist of portions
of product that proportionally represent each of the materials from which the product is made.
5.2.3 The SIP can be calculated on the basis of length, mass, volume or surface area (see Table A.1 for
examples).
5.2.4 The adequacy of a selected SIP shall be demonstrated.
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NOTE Some standards specifying requirements for validation and routine control of the sterilization
process stipulate criteria for the adequacy of the SIP, e.g. the ISO 11137 series.
5.3 Packaging of product and sample item portions
It is recommended that packaging for product or SIPs be the same as that used in routine production.
If packaging materials and/or processes are different from those used in routine production, it shall be
documented. Selection of packaging material and the method of packaging shall ensure that:
a) product or SIP receives the intended treatment with the sterilizing agent,
b) microbiological status of product or SIP is maintained, and
c) access of the sterilizing agent to product or SIP is equivalent to that achieved with packaging used
in routine production.
6 Methods for performing tests of sterility
6.1 There are two general methods for performing tests of sterility:
a) Direct immersion of product in growth medium or addition of growth medium to product, followed
by incubation. The product shall be immersed in the media for the duration of the incubation
time where practicable. A rationale shall be provided if this is not possible, such as with buoyant
materials.
b) Removal of microorganisms from product and transfer of removed microorganisms to growth
medium followed by incubation.
6.2 For an identified product, factors that influence the design of the method for performing tests of
sterility shall be considered and recorded (see 4.1.2). Factors to be considered include, at least:
a) the part(s) of product for which sterility is claimed on the label,
b) the physical and/or chemical nature of product to be tested (see also 6.6), and
c) possible type(s) of contaminating microorganisms and their locations on/in product.
6.3 In performing tests of sterility, aseptic technique shall be applied in carrying out manipulations
that might affect the result of the test.
6.4 If microorganisms are to be removed from product by elution before transfer to growth medium
(see 6.1 b)), fac
...
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