EN ISO 14937:2009

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

ISO 14937:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.
It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.

Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 14937:2009)

1.1   Im Anwendungsbereich enthalten
1.1.1   Diese Internationale Norm legt allgemeine Anforderungen an die Charakterisierung eines sterilisierenden Agens sowie für die Entwicklung, Validierung und Lenkung der Anwendung und Überwachung eines Sterilisationsverfahrens für Medizinprodukte fest.
ANMERKUNG   Obgleich der Anwendungsbereich dieser Internationalen Norm auf Medizinprodukte begrenzt ist, können die hier festgelegten Anforderungen auch auf Sterilisationsverfahren für weitere Produkte für die Gesundheitsfürsorge angewendet werden.
1.1.2   Diese Internationale Norm gilt für Sterilisationsverfahren, in denen Mikroorganismen durch physikalische und/oder chemische Mittel inaktiviert werden.
1.1.3   Diese Internationale Norm ist dafür vorgesehen, dass sie von Verfahrensentwicklern, Herstellern von Sterilisationsausrüstungen, Herstellern von zu sterilisierenden Medizinprodukten sowie von Organisationen, die Verantwortung für die Sterilisation von Medizinprodukten tragen, angewendet wird.
1.1.4   Diese Internationale Norm legt die Elemente eines Qualitätsmanagementsystems fest, die erforderlich sind, um die geeignete Charakterisierung eines sterilisierenden Agens, die Entwicklung, Validierung, Lenkung der Anwendung und die Überwachung eines Sterilisationsverfahrens für Medizinprodukte sicherzustellen.
ANMERKUNG   Es ist keine Anforderung dieser Internationalen Norm, dass ein vollständiges Qualitäts-managementsystem eingerichtet ist. Auf die erforderlichen Elemente eines Qualitätsmanagementsystems wird an den entsprechenden Stellen im Text normativ verwiesen (siehe insbesondere Abschnitt 4). Hingewiesen wird auf die Normen für Qualitätsmanagementsysteme (siehe ISO 13485), die alle Schritte der Herstellung und Aufbereitung von Medizin¬produkten lenken. Regionale und nationale Bestimmungen für die Bereitstellung von Medizinprodukten können die Einführung eines vollständigen Qualitätsmanagementsystems und dessen Beurteilung durch eine dritte Seite fordern.
(...)

Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 14937:2009)

L'ISO 14937:2009 spécifie les exigences générales pour la caractérisation d'un agent stérilisant, et pour la mise au point, la validation et la surveillance et le contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux.
Elle s'applique aux procédés de stérilisation par lesquels des micro-organismes sont inactivés par un moyen physique et/ou chimique et est destinée à être appliquée par les responsables de la conception des procédés, les fabricants d'équipements de stérilisation, les fabricants de dispositifs médicaux à stériliser et les organismes responsables de la stérilisation de dispositifs médicaux.
L'ISO 14937:2009 spécifie les éléments d'un système de management de la qualité nécessaires pour garantir la caractérisation appropriée de l'agent stérilisant, la mise au point, la validation et la surveillance et le contrôle de routine appropriés d'un procédé de stérilisation.

Sterilizacija izdelkov za zdravstveno nego - Splošne zahteve za opredelitev lastnosti sterilizacijskih sredstev in za razvoj, validacijo ter rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 14937:2009)

Ta mednarodni standard določa splošne zahteve za opredelitev lastnosti sterilizacijskih sredstev in za razvoj, validacijo in rutinsko spremljanje in kontrolo sterilizacijskih postopkov za medicinske pripomočke. Ta mednarodni standard velja za sterilizacijske postopke, pri katerih se mikroorganizmi inaktivirajo s fizičnimi in/ali kemičnimi sredstvi. Ta mednarodni standard je namenjen razvijalcem postopkov, proizvajalcem sterilizacijske opreme, proizvajalcem medicinskih pripomočkov, ki se sterilizirajo, in organizacijam, odgovornim za sterilizacijo medicinskih pripomočkov. Ta mednarodni standard določa elemente sistema vodenja kakovosti, ki so potrebni za zagotavljanje potrebne opredelitve lastnosti sterilizacijskih sredstev, razvoj, validacijo in rutinsko spremljanje ter kontrolo sterilizacijskih postopkov.

General Information

• Status: Published
• Publication Date: 14-Oct-2009
• Withdrawal Date: 29-Apr-2010
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 9 - General requirements for sterilization
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Oct-2009
• Completion Date: 15-Oct-2009
• 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
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14937:2010 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

Relations

• Replaces: EN ISO 14937:2000 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
• Effective Date: 17-Oct-2009
• Replaces: EN ISO 14937:2000/AC:2003 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
• Effective Date: 17-Oct-2009
• Replaces: EN ISO 14937:2000/AC:2005 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 14937:2001
SIST EN ISO 14937:2001/AC:2004
SIST EN ISO 14937:2001/AC:2005
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6SORãQH]DKWHYH]DRSUHGHOLWHY
ODVWQRVWLVWHULOL]DFLMVNLKVUHGVWHYLQ]DUD]YRMYDOLGDFLMRWHUUXWLQVNRNRQWUROR
VWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNHSULSRPRþNH,62
Sterilization of health care products - General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization
process for medical devices (ISO 14937:2009)
Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an
die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung
und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO
14937:2009)
Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un
agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un
processus de stérilisation pour dispositifs médicaux (ISO 14937:2009)
Ta slovenski standard je istoveten z: EN ISO 14937:2009
ICS:
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 14937
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2009
ICS 11.080.01 Supersedes EN ISO 14937:2000
English Version
Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development,
validation and routine control of a sterilization process for
medical devices (ISO 14937:2009)
Stérilisation des produits de santé - Exigences générales Sterilisation von Produkten für die Gesundheitsfürsorge -
pour la caractérisation d'un agent stérilisant et pour la mise Allgemeine Anforderungen an die Charakterisierung eines
au point, la validation et la vérification de routine d'un sterilisierenden Agens und an die Entwicklung, Validierung
processus de stérilisation pour dispositifs médicaux (ISO und Lenkung der Anwendung eines Sterilisationsverfahrens
14937:2009) für Medizinprodukte (ISO 14937:2009)
This European Standard was approved by CEN on 24 September 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 14937:2009: 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 14937:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 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 14937:2000.
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 Annex ZA, B and C, 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 14937:2009 has been approved by CEN as a EN ISO 14937:2009 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 EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential Requirement 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 EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 8.4
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 EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 2.3 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 2.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

INTERNATIONAL ISO
STANDARD 14937
Second edition
2009-10-15
Sterilization of health care products —
General requirements for characterization
of a sterilizing agent and the
development, validation and routine
control of a sterilization process for
medical devices
Stérilisation des produits de santé — Exigences générales pour la
caractérisation d'un agent stérilisant et pour la mise au point, la
validation et la vérification de routine d'un processus de stérilisation
pour dispositifs médicaux
Reference number
ISO 14937:2009(E)
©
ISO 2009
ISO 14937:2009(E)
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ISO 14937:2009(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
1.1 Inclusions.1
1.2 Exclusions.1
2 Normative references.2
3 Terms and definitions .2
4 Quality management system elements.7
4.1 Documentation .7
4.2 Management responsibility .7
4.3 Product realization .8
4.4 Measurement, analysis and improvement — Control of non-conforming product.8
5 Sterilizing agent charac
...