EN ISO 14971:2000

SLOVENSKI STANDARD
01-november-2001
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SIST EN 1441:2000
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Medical devices - Application of risk management to medical devices (ISO 14971:2000)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2000)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2000)
Ta slovenski standard je istoveten z: EN ISO 14971:2000
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
December 2000
ICS 11.040.01 Supersedes EN 1441:1997
English version
Medical devices - Application of risk management to medical
devices (ISO 14971:2000)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements
aux dispositifs médicaux (ISO 14971:2000) auf Medizinprodukte (ISO 14971:2000)
This European Standard was approved by CEN on 3 December 2000, and by CENELEC on 2 May 2001.
CEN/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 Management Centre or to any CEN/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/CENELEC member into its own language and notified to the Management Centre has the same status as
the official versions.
CEN/CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
rue de Stassart, 36  B-1050 Brussels rue de Stassart, 35  B-1050 Brussels
© 2000 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14971:2000 E
worldwide for CEN national Members and for CENELEC
Members.
Page 2
Foreword
The text of the International Standard ISO 14971:2000 has been prepared by
Technical Committee ISO/TC 210 "Quality management and corresponding general
aspects for medical devices" in collaboration with IEC/SC 62A, CEN Management
Centre (CMC) and CENELEC.
This European Standard supersedes EN 1441:1997, for which the date of withdrawal
is extended. National implementations of EN 1441:1997 shall be withdrawn at the
latest by March 2004.
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 June 2001, and
conflicting national standards shall be withdrawn at the latest by March 2004.
This European Standard 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).
According to the CEN/CENELEC Internal Regulations, the national standards
organizations of the following countries are bound to implement this European
Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany,
Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
Annexes A to G are informative.
Endorsement notice
The text of the International Standard ISO 14971:2000 was approved by
CEN/CENELEC as a European Standard without any modification.

INTERNATIONAL ISO
STANDARD 14971
First edition
2000-12-15
Medical devices — Application of risk
management to medical devices
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
Reference number
ISO 14971:2000(E)
©
ISO 2000
ISO 14971:2000(E)
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ii © ISO 2000 – All rights reserved

ISO 14971:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Terms and definitions .1
3 General requirements for risk management.4
3.1 National or regional regulatory requirements .4
3.2 Risk management process .4
3.3 Management responsibilities .4
3.4 Qualification of personnel .5
3.5 Risk management plan.5
3.6 Risk management file.6
4 Risk analysis (Steps 1, 2 and 3 of Figure 2) .6
4.1 Risk analysis procedure .6
4.2 Intended use/intended purpose and identification of characteristics related to the safety of the
medical device (Step 1) .6
4.3 Identification of known or foreseeable hazards (Step 2) .8
4.4 Estimation of the risk(s) for each hazard (Step 3) .8
5 Risk evaluation (Step 4).9
6 Risk control (Steps 5 to 10) .9
6.1 Risk reduction.9
6.2 Option analysis (Step 5) .9
6.3 Implementation of risk control measure(s) (Step 6).9
6.4 Residual risk evaluation (Step 7).10
6.5 Risk/benefit analysis (Step 8) .10
6.6 Other generated hazards (Step 9).10
6.7 Completeness of risk evaluation (Step 10).10
7 Overall residual risk evaluation (Step 11).10
8 Risk management report (Step 12).10
9 Post-production information (Step 13) .11
Annex A (informative) Questions that can be used to identify medical device characteristics that could
impact on safety.12
Annex B (informative) Guidance on risk analysis for in vitro diagnostic medical devices.16
Annex C (informative) Guidance on risk analysis procedure for toxicological hazards .17
Annex D (informative) Examples of possible hazards and contributing factors associated with medical
devices.19
Annex E (informative) Risk concepts applied to medical devices .23
Annex F (informative) Information on risk analysis techniques .28
Annex G (informative) Other standards that contain information related to the elements of risk
management described in this International Standard.30
Bibliography.31
ISO 14971:2000(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
In the field of risk management for medical devices, Technical Committee ISO/TC 210 and IEC/SC 62A have
established a joint working group, JWG 1, Application of risk management to medical devices.
International Standard ISO 14971 was prepared by ISO/TC 210, Quality management and corresponding general
aspects for medical devices, and Subcommittee IEC/SC 62A, Common aspects of electrical equipment used in
medical practice.
Requirements concerning the risk analysis component of the risk management process were developed first and
published as ISO 14971-1:1998, with the intention that the requirements for risk evaluation, risk control and post-
production information evaluation could be covered in additional part(s), but all the requirements have now been
incorporated into this International Standard.
This first edition of ISO 14971 cancels and replaces ISO 14971-1:1998.
For purposes of future IEC maintenance, Subcommittee 62A has decided that this publication remains valid until
2004. At this date, Subcommittee 62A, in consultation with ISO/TC 210, will decide whether the publication will be
� reconfirmed,
� withdrawn,
� replaced by a revised edition, or
� amended.
Annexes A to G of this International Standard are for information only.
iv © ISO 2000 – All rights reserved

ISO 14971:2000(E)
Introduction
This International Standard should be regarded as a framework for effective management by the manufacturer of
the risks associated with the use of medical devices. The requirements that it contains provide a framework within
which experience, insight and judgement are applied systematically to manage these risks.
As a general concept, activities in which an individual, organization or government is involved can expose those or
other stakeholders to hazards which may cause loss or damage of somet
...