EN ISO 14971:2007

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

20060711  Special foreword and Annex Z to be used as provided by AAG.
20050816  Previously registered under ref ISO 14971-1 - changed to ISO 14971 at ISO request (see below explanation from T. Hancox) "The information is : two pieces of one future Standard are being developed separately, but the intention is that they will be regarded as a single Standard + annex. Annex B is being developed by TC 212, at the request of TC 210. The revision of the existing 14971: 2000 is at stage 0 because the published document is still valid. When the Annex is nearer publication, it is intended that we take the decision how much revision might be necessary or indeed whether the Annex should be published as an Amendment to a still-valid (i.e. unchanged) 2000 publication." (NT).
(AAG: 2006-05-03) Please check with A Ganesh before vote and before DAV to ensure that correct European foreword is introduced.

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2007)

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 Risiko¬management kann jedoch ein Bestandteil eines Qualitätsmanagementsystems sein.

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007)

Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2007)

General Information

• Status: Withdrawn
• Publication Date: 14-Mar-2007
• Withdrawal Date: 14-Jul-2009
• ICS: 11.040.01 - Medical equipment 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: 15-Jul-2009
• Completion Date: 15-Jul-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/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14971:2007 - Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Relations

• Replaces: EN ISO 14971:2000/AC:2002 - Medical devices - Application of risk management to medical devices (ISO 14971:2000)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 14971:2000/A1:2003 - Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 14971:2000 - Medical devices - Application of risk management to medical devices (ISO 14971:2000)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 14971:2009 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2007
1DGRPHãþD
SIST EN ISO 14971:2001
SIST EN ISO 14971:2001/A1:2003
SIST EN ISO 14971:2001/AC:2003
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK,62
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2007)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2007)
Ta slovenski standard je istoveten z: EN ISO 14971:2007
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
March 2007
ICS 11.040.01 Supersedes EN ISO 14971:2000
English Version
Medical devices - Application of risk management to medical
devices (ISO 14971:2007)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements auf
aux dispositifs médicaux (ISO 14971:2007) Medizinprodukte (ISO 14971:2007)
This European Standard was approved by CEN on 9 March 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14971:2007: E
worldwide for CEN national Members.

Foreword
The text of the International Standard ISO/FDIS 14971:2006 has been prepared by Technical
Committee ISO/TC 210 "Quality management and corresponding general aspects for medical
devices, Joint Working Group 1". The transposition into a European Standard has been
managed by the CEN Management Centre (CMC) with the assistance of the CEN Advisory
Board for Health Standards.
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 September 2007, and conflicting national
standards shall be withdrawn at the latest by September 2007.

This document supersedes EN ISO 14971:2000.

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
Directive(s).
For relationship with Essential Requirements in EU Directive(s), see informative Annex ZA,
which is 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 United
Kingdom.
Endorsement notice
The text of ISO 14971:2007 has been approved by CEN as EN ISO 14971:2007 without any
modifications.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directives 93/42/EEC Medical Devices,
90/385/EEC Active Implantable Medical Devices and 98/79/EC 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 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.

Because this standard describes an ongoing process it is not possible to link individual clauses
to specific corresponding Essential Requirements. This standard provides a process for
managing risks associated with medical devices. Compliance with all the requirement clauses in
this standard will ensure that general aspects of medical devices related to 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.
Relevant harmonized standards may be used for this purpose. The risk management processes
described in this standard could establish the need for collection of clinical or other experimental
data. 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 the product(s)
falling within the scope of this standard.

INTERNATIONAL ISO
STANDARD 14971
Second edition
2007-03-01
Medical devices — Application of risk
management to medical devices
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
Reference number
ISO 14971:2007(E)
©
ISO 2007
ISO 14971:2007(E)
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ISO 14971:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 General requirements for risk management . 5
3.1 Risk management process . 5
3.2 Management responsibilities . 7
3.3 Qualification of personnel . 7
3.4 Risk management plan. 7
3.5 Risk management file. 8
4 Risk analysis . 8
4.1 Risk analysis process . 8
4.2 Intended use and identification of characteristics related to the safety of the medical
device. 9
4.3 Identification of hazards . 9
4.4 Estimation of the risk(s) for each hazardous situation. 9
5 Risk evaluation. 10
6 Risk control . 11
6.1 Risk reduction . 11
6.2 Risk control option analysis. 11
6.3 Implementation of risk control measure(s). 11
6.4 Residual risk evaluation. 12
6.5 Risk/benefit analysis . 12
6.6 Risks arising from risk control measures.12
6.7 Completeness of risk control . 12
7 Evaluation of overall residual risk acceptability . 13
8 Risk management report. 13
9 Production and post-production information. 13
Annex A (informative) Rationale for requirements . 15
Annex B (informative) Overview of the risk management process for medical devices . 23
Annex C (informative) Questions that can be used to identify medical device characteristics that
could impact on safety. 25
Annex D (informative) Risk concepts applied to medical devices. 32
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous
situations .
...