EN ISO 11737-2:2009

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

ISO 11737-2:2009 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.

Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2: Prüfungen der Sterilität bei der Definition, Validierung und Aufrechterhaltung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11737-2:2009)

1.1   Dieser Teil von ISO 11737 legt die allgemeinen Kriterien für Prüfungen der Sterilität von Medizin-produkten fest, die einer Behandlung mit dem sterilisierenden Agens unterzogen wurden, die auf das Maß verringert wurde, welches bei routinemäßigen Sterilisationsverfahren erwartet wird. Diese Prüfungen sind vorgesehen, wenn ein Sterilisationsverfahren definiert, validiert oder aufrechterhalten wird.
1.2   Dieser Teil von ISO 11737 ist nicht anwendbar auf:
a)   die Sterilitätsprüfung für die Routinefreigabe eines Produkts, das einem Sterilisationsverfahren unterzogen wurde;
b)   das Durchführen einer Prüfung auf Sterilität (siehe 3.12);
ANMERKUNG 1   Die Durchführung nach a) oder b) ist keine Anforderung von ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 oder ISO 17665-1.
c)   die Kulturanzüchtung biologischer Indikatoren oder beimpfter Produkte.
ANMERKUNG 2   Ein Leitfaden über die Kulturanzüchtung biologischer Indikatoren ist in ISO 14161 [8] enthalten.

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 11737-2:2009)

L'ISO 11737-2:2009 spécifie les critères généraux pour les essais de stérilité des dispositifs médicaux qui ont été soumis à un traitement par l'agent stérilisant, réduits en fonction de l'utilisation prévue du 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 medicinskih pripomočkov - Mikrobiološke metode - 2. del: Preskusi sterilnosti pri definiciji, validaciji in vzdrževanju sterilizacijskih postopkov (ISO 11737-2:2009)

Ta del ISO 11737 določa splošna merila za preskuse sterilnosti medicinskih pripomočkov, ki so bili izpostavljeni obdelavi s sterilizacijskim sredstvom, kar je del določenega sterilizacijskega postopka. Ti preskusi se izvajajo pri definiciji, validaciji ali vzdrževanju sterilizacijskih postopkov.

General Information

• Status: Withdrawn
• Publication Date: 14-Nov-2009
• Withdrawal Date: 12-May-2020
• ICS: 07.100.10 - Medical microbiology
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 5 - Bioburden of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 13-May-2020
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Ref Project: SIST EN ISO 11737-2:2010 - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

Relations

• Replaces: EN ISO 11737-2:2000 - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11737-2:2020 - 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)
• Effective Date: 17-Feb-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2010
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SIST EN ISO 11737-2:2001
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY0LNURELRORãNHPHWRGHGHO3UHVNXVL
VWHULOQRVWLSULGHILQLFLMLYDOLGDFLMLLQY]GUåHYDQMXVWHULOL]DFLMVNLKSRVWRSNRY,62

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

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

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11737-2:2009: E
worldwide for CEN national Members.

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

Foreword
This document (EN ISO 11737-2:2009) has been prepared by Technical Committee ISO/TC 198 "Sterilization
of health care products" in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical
devices” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the
latest by May 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11737-2:2000.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.
For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral parts of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11737-2:2009 has been approved by CEN as a EN ISO 11737-2:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this European Essential Requirements Qualifying remarks/Notes
Standard (ERs) of Directive 90/385/EEC
This relevant Essential Requirement
4,5,6,7,8 7
is only partly addressed in this
European Standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this European Essential Requirements
Qualifying remarks/Notes
Standard (ERs) of Directive 93/42/EEC
4,5,6,7,8 8.3 This relevant Essential Requirement
is only partly addressed in this
European Standard
This relevant Essential Requirement
4,5,6,7,8 8.4
is only partly addressed in this
European Standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC on in vitro diagnostic medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this European Essential Requirements (ERs) Qualifying remarks/Notes
Standard of Directive 98/79/EC
This relevant Essential Requirement
4,5,6,7,8 B.2.3
is only partly addressed in this
European Standard
This relevant Essential Requirement
4,5,6,7,8 B.2.4
is only partly addressed in this
European Standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 11737-2
Second edition
2009-11-15
Sterilization of medical devices —
Microbiological methods —
Part 2:
Tests of sterility performed in the
definition, validation and maintenance of
a sterilization process
Stérilisation des dispositifs médicaux — Méthodes microbiologiques —
Partie 2: Essais de stérilité pratiqués au moment de la définition, de la
validation et de la maintenance d'un procédé de stérilisation

Reference number
ISO 11737-2:2009(E)
©
ISO 2009
ISO 11737-2:2009(E)
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ISO 11737-2:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Quality management system elements.3
4.1 Documentation .3
4.2 Management responsibility .3
4.3 Product realization .4
4.4 Measurement, analysis and improvement.4
5 Selection of product.4
5.1 General .4
5.2 Sample item portion (SIP).
...