EN ISO 14971:2009

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2007, korrigierte Fassung 2007-10-01)

Diese Internationale Norm legt einen Prozess für einen Medizinproduktehersteller fest zur Identifizierung der mit
Medizinprodukten verbundenen Gefährdungen, einschließlich Produkte für die In-vitro-Diagnostik (IVD). Er
dient der Einschätzung und der Bewertung zugehöriger Risiken, zur Beherrschung dieser Risiken und der
Überwachung der Wirksamkeit von Maßnahmen zur Risikobeherrschung.
Die Anforderungen dieser Internationalen Norm gelten für alle Phasen des Lebenszyklus eines
Medizinprodukts.
Diese Internationale Norm gilt nicht für die klinische Entscheidungsfindung.
In dieser Norm werden keine vertretbaren Risikobereiche festgelegt.
Diese Norm fordert nicht, dass der Hersteller über ein Qualitätsmanagementsystem verfügt. Das Risikomanagement
kann jedoch ein Bestandteil eines Qualitätsmanagementsystems sein.

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigée de 2007-10-01)

L'ISO 14971:2007 spécifie un processus pour permettre au fabricant d'identifier les phénomènes dangereux et les situations dangereuses associés aux dispositifs médicaux, y compris les dispositifs médicaux de diagnostic in vitro (DIV), d'estimer et d'évaluer les risques, de maîtriser ces risques et de surveiller l'efficacité de cette maîtrise.
Les exigences de l'ISO 14971:2007 s'appliquent à tous les stades du cycle de vie d'un dispositif médical.

Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2007, popravljena verzija 2007-10-01)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2009
• Withdrawal Date: 03-Jul-2012
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Jul-2012
• Completion Date: 04-Jul-2012
• 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
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14971:2009 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Relations

• Replaces: EN ISO 14971:2007 - Medical devices - Application of risk management to medical devices (ISO 14971:2007)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
• Effective Date: 23-May-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14971:2009
01-november-2009
1DGRPHãþD
SIST EN ISO 14971:2007
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK,62SRSUDYOMHQDYHU]LMD
Medical devices - Application of risk management to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2007)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2007, Version corrigé 2007-10-01)
Ta slovenski standard je istoveten z: EN ISO 14971:2009
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14971:2009

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SIST EN ISO 14971:2009



EUROPEAN STANDARD
EN ISO 14971

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2009
ICS 11.040.01 Supersedes EN ISO 14971:2007
English version
Medical devices - Application of risk management to medical
devices (ISO 14971:2007, Corrected version 2007-10-01)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements auf
aux dispositifs médicaux (ISO 14971:2007, Version Medizinprodukte (ISO 14971:2007, korrigierte Fassung
corrigée de 2007-10-01) 2007-10-01)
This European Standard was approved by CEN on 13 June 2009.

CEN and CENELEC 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 or CENELEC 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 or CENELEC member into its own language and notified to the CEN Management Centre has the same
status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, 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.







CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2009 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14971:2009 E
worldwide for CEN national Members and for CENELEC
Members.

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SIST EN ISO 14971:2009
EN ISO 14971:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable 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 Devices .6

2

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SIST EN ISO 14971:2009
EN ISO 14971:2009 (E)
Foreword
The text of ISO 14971:2007, Corrected version 2007-10-01 has been prepared by Technical Committee
ISO/TC 210 “Quality management and corresponding general aspects for medical devices” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 14971:2009 by Technical
Committee CEN/CLC TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
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 January 2010, and conflicting national standards shall be withdrawn at
the latest by March 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 14971:2007.
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