SIST EN ISO 11737-2:2020

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

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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.

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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.
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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.
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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.
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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
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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
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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)

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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
...