EN ISO 14971:2009
(Main)Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2009
1DGRPHãþD
SIST EN ISO 14971:2007
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK ,62 SRSUDYOMHQDYHU]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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 93/42/EEC on
Medical Devices, 90/385/EEC on Active Implantable Medical Devices and 98/79/EC on In Vitro Diagnostic
Devices.
For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are an integral part of this
document.
The present standard can also be used to support some parts of the conformity assessment procedures
described in annexes of the European medical devices directives (90/385/EEC, 93/42/EEC and (98/79/EC):
− an adequate description of: results of the risk analysis,
− an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review
experience gained from devices in the post-production phase and to implement appropriate means to
apply any necessary corrective action
NOTE: Other requirements may be applicable to this aspect
In establishing the policy for determining risk acceptability criteria, this standard allows manufacturers to
choose from a range of options within those permitted by regulations (see clause 3.2). European medical
devices directives require that, in selecting the most appropriate solutions for the design and construction of
the devices, these solutions must conform to safety principles, taking account of the generally acknowledged
state of the art, and the manufacturer must apply the following principles in the following order:
• eliminate or reduce risks as far as possible (inherently safe design and construction),
• where appropriate take adequate protection measures including alarms if necessary, in relation to
risks that cannot be eliminated,
• inform users of the residual risks due to any shortcomings of the protection measures adopted.
In this context, ‘eliminating’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account
of technology and practice existing at the time of design and of technical and economical considerations
compatible with a high level of protection of health and safety; (see also Annex D.8).
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 14971:2007, Corrected version 2007-10-01 has been approved by CEN as a EN ISO
14971:2009 without any modification.
Annex ZA
(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 Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard 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.
This standard provides a process for managing risks associated with medical devices. Because this standard
describes an ongoing process applicable in part or in all to the Essential Requirements of Directive 93/42/EEC
on medical devices, it is not meaningful to link individual clauses of the standard to specific corresponding
Essential Requirements.
Compliance with all the requirement clauses in this standard will ensure that general aspects of medical
devices related to patient risk and safety have been addressed. For particular medical devices or for particular
safety aspects, additional specific requirements may need to be complied with in order to meet the essential
requirements. With respect to users of medical devices and third persons, additional specific requirements
from other EU Directives may need to be complied with in order to meet Essential Requirement 1. Relevant
harmonized standards may also be used for these purposes.
The risk management processes described in this standard could establish the need for collection of clinical or
other experimental data for risk-benefit evaluation purposes. It does not describe how this has to be carried
out. Relevant harmonized standards may be used for this purpose.
WARNING — Other requirements and other EU Directives may be applicable to a product falling within the
scope of this standard.
Annex ZB
(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 Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard 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.
This standard provides a process for managing risks associated with medical devices. Because this standard
describes an ongoing process applicable in part or in all to the Essential Requirements of Directive
90/385/EEC on active implantable medical devices, it is not meaningful to link individual clauses of the
standard to specific corresponding Essential Requirements.
Compliance with all the requirement clauses in this standard will ensure that general aspects of medical
devices related to patient risk and safety have been addressed. For particular medical devices or for particular
safety aspects, additional specific requirements may need to be complied with in order to meet the essential
requirements. With respect to users of medical devices and third persons, additional specific requirements
from other EU Directives may need to be complied with in order to meet Essential Requirement 1. Relevant
harmonized standards may also be used for these purposes.
The risk management processes described in this standard could establish the need for collection of clinical or
other experimental data for risk-benefit evaluation purposes. It does not describe how this has to be carried
out. Relevant harmonized standards may be used for this purpose.
WARNING — Other requirements and other EU Directives may be applicable to a product 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 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 devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard 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.
This standard provides a process for managing risks associated with medical devices. Because this standard
describes an ongoing process applicable in part or in all to the Essential Requirements of Directive 98/79/EC
on in vitro diagnostic devices, it is not meaningful to link individual clauses of the standard to specific
corresponding Essential Requirements.
Compliance with all the requirement clauses in this standard will ensure that general aspects of medical
devices related to patient risk and safety have been addressed. For particular medical devices or for particular
safety aspects, additional specific requirements may need to be complied with in order to meet the essential
requirements. With respect to users of medical devices and third persons, additional specific requirements
from other EU Directives may need to be complied with in order to meet Essential Requirement 1. Relevant
harmonized standards may also be used for these purposes.
The risk management processes described in this standard could establish the need for collection of clinical or
other experimental data for risk-benefit evaluation purposes. It does not describe how this has to be carried
out. Relevant harmonized standards may be used for this purpose.
WARNING — Other requirements and other EU Directives may be applicable to a product falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 14971
Second edition
2007-03-01
Corrected version
...
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