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)

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 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.
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),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
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.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

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)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
13-May-2020
Completion Date
13-May-2020

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 11737-2:2020
---------------------- Page: 2 ----------------------
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.
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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.
---------------------- Page: 9 ----------------------
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.
---------------------- Page: 11 ----------------------
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
---------------------- Page: 12 ----------------------
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.
---------------------- Page: 13 ----------------------
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
---------------------- Page: 14 ----------------------
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.
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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

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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Email: copyright@iso.org
Website: www.iso.org
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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