SIST 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)
This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
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 Risikomanagement
kann jedoch ein Bestandteil eines Qualitätsmanagementsystems sein.
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigé 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
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14971:2009
01-november-2009
1DGRPHãþD
SIST EN ISO 14971:2007
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
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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.
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.
3
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SIST EN ISO 14971:2009
EN ISO 14971:2009 (E)
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.
4
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SIST EN ISO 14971:2009
EN ISO 14971:2009 (E)
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.
5
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SIST EN ISO 14971:2009
EN ISO 14971:2009 (E)
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.
6
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SIST EN ISO 14971:2009
INTERNATIONAL ISO
STANDARD 14971
Second edition
2007-03-01
Corrected version
2007-10-01
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
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SIST EN ISO 14971:2009
ISO 14971:2007(E)
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ii © ISO 2007 – All rights reserved
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SIST EN ISO 14971:2009
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 . 49
Annex F (informative) Risk management plan . 54
Annex G (informative) Information on risk management techniques. 56
Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices. 60
Annex I (informative) Guidance on risk analysis process for biological hazards. 76
Annex J (informative) Information for safety and information about residual risk . 78
Bibliography . 80
© ISO 2007 – All rights reserved iii
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SIST EN ISO 14971:2009
ISO 14971:2007(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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
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. Annex H, “Guidance on risk management for in vitro diagnostic medical
devices”, was prepared by ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.
This second edition cancels and replaces the first edition (ISO 14971:2000) as well as the amendment
ISO 14971:2000/Amd.1:2003.
For purposes of future IEC maintenance, Subcommittee 62A has decided that the contents of this publication will
1)
remain unchanged until the maintenance result date indicated on the IEC web site under http://webstore.iec.ch
in the data related to the specific publication. At this date, the publication will be
⎯ reconfirmed,
⎯ withdrawn,
⎯ replaced by a revised edition or
⎯ amended.
This corrected version of ISO 14971:2007 incorporates the following correction:
⎯ a corrected version of Figure 1 on page 6.
1) IEC National Committees are requested to note that for this publication the maintenance result date is 2014.
iv © ISO 2007 – All rights reserved
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SIST EN ISO 14971:2009
ISO 14971:2007(E)
Introduction
The requirements contained in this International Standard provide manufacturers with a framework within
which experience, insight and judgment are applied systematically to manage the risks associated with the
use of medical devices.
This International Standard was developed specifically for medical device/system manufacturers using
established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this
International Standard could be used as informative guidance in developing and maintaining a risk
management system and process.
This International Standard deals with processes for managing risks, primarily to the patient, but also to the
operator, other persons, other equipment and the environment.
As a general concept, activities in which an individual, organization or government is involved can expose
those or other stakeholders to hazards which can cause loss of or damage to something they value. Risk
management is a complex subject because each stakeholder places a different value on the probability of
harm occurring and its severity.
It is accepted that the concept of risk has two components:
a) the probability of occurrence of harm;
b) the consequences of that harm, that is, how severe it might be.
The concepts of risk management are particularly important in relation to medical devices because of the
variety of stakeholders including medical practitioners, the organizations providing health care, governments,
industry, patients and members of the public.
All stakeholders need to understand that the use of a medical device entails some degree of risk. The
acceptability of a risk to a stakeholder is influenced by the components listed above and by the stakeholder’s
perception of the risk. Each stakeholder’s perception of the risk can vary greatly depending upon their cultural
background, the socio-economic and educational background of the society concerned, the actual and
perceived state of health of the patient, and many other factors. The way a risk is perceived also takes into
account, for example, whether exposure to the hazard seems to be involuntary, avoidable, from a man-made
source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within
society. The decision to use a medical device in the context of a particular clinical procedure requires the
residual risks to be balanced against the anticipated benefits of the procedure. Such judgments should take
into account the intended use, performance and risks associated with the medical device, as well as the risks
and benefits associated with the clinical procedure or the circumstances of use. Some of these judgments can
be made only by a qualified medical practitioner with knowledge of the state of health of an individual patient
or the patient’s own opinion.
As one of the stakeholders, the manufacturer makes judgments relating to safety of a medical device,
including the acceptability of risks, taking into account the generally accepted state of the art, in order to
determine the suitability of a medical device to be placed on the market for its intended use. This International
Standard specifies a process through which the manufacturer of a medical device can identify hazards
associated with a medical device, estimate and evaluate the risks associated with these hazards, control
these risks, and monitor the effectiveness of that control.
For any particular medical device, other International Standards could require the application of specific
methods for managing risk.
© ISO 2007 – All rights reserved v
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SIST EN ISO 14971:2009
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SIST EN ISO 14971:2009
INTERNATIONAL STANDARD ISO 14971:2007(E)
Medical devices — Application of risk management to medical
devices
1 Scope
This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical
device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk l
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.VNLKMedizinprodukte - 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)Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:FprEN ISO 14971kSIST FprEN ISO 14971:2009enkSIST FprEN ISO 14971:2009SLOVENSKI
STANDARD
kSIST FprEN ISO 14971:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTFprEN ISO 14971February 2009ICS 11.040.01Will supersede EN ISO 14971:2007
English versionMedical devices - Application of risk management to medicaldevices (ISO 14971:2007, Corrected version 2007-10-01)Dispositifs médicaux - Application de la gestion des risquesaux dispositifs médicaux (ISO 14971:2007, Version corrigé2007-10-01)Medizinprodukte - Anwendung des Risikomanagements aufMedizinprodukte (ISO 14971:2007)This draft European Standard is submitted to CEN/CENELEC members for unique acceptance procedure. It has been drawn up by theTechnical Committee CEN/CLC/TC 3.If this draft becomes a European Standard, CEN/CENELEC members are bound to comply with the CEN/CENELEC Internal Regulationswhich stipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN/CENELEC in three official versions (English, French, German). A version in anyother language made by translation under the responsibility of a CEN/CENELEC member into its own language and notified to the CENManagement 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,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 UnitedKingdom.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.CEN Management Centre:CENELEC Central Secretariat:Avenue Marnix 17, B-1000 BrusselsAvenue Marnix 17, B-1000 Brussels© 2009 CEN/CENELECAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members and for CENELECMembers.Ref. No. FprEN ISO 14971:2009 EkSIST FprEN ISO 14971:2009
FprEN ISO 14971:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices .4Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices .5Annex ZC (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 98/79/EC on In Vitro Diagnostic Devices .6 kSIST FprEN ISO 14971:2009
FprEN ISO 14971:2009 (E) 3 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 FprEN 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 document is currently submitted to the Unique Acceptance Procedure. This document will supersede 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). Endorsement notice The text of ISO 14971:2007, Corrected version 2007-10-01 has been approved by CEN as a FprEN ISO 14971:2009 without any modification.
kSIST FprEN ISO 14971:2009
FprEN ISO 14971:2009 (E) 4 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.
kSIST FprEN ISO 14971:2009
FprEN ISO 14971:2009 (E) 5 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.
kSIST FprEN ISO 14971:2009
FprEN ISO 14971:2009 (E) 6 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.
kSIST FprEN ISO 14971:2009
Reference numberISO 14971:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO14971Second edition2007-03-01Corrected version2007-10-01Medical devices — Application of risk management to medical devices Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
kSIST FprEN ISO 14971:2009
ISO 14971:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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kSIST FprEN ISO 14971:2009
ISO 14971:2007(E) © ISO 2007 – All rights reserved iiiContents 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.49 Annex F (informative)
Risk management plan.54 Annex G (informative)
Information on risk management techniques.56 Annex H (informative)
Guidance on risk management for in vitro diagnostic medical devices.60 Annex I (informative)
Guidance on risk analysis process for biological hazards.76 Annex J (informative)
Information for safety and information about residual risk.78 Bibliography.80
kSIST FprEN ISO 14971:2009
ISO 14971:2007(E) iv © ISO 2007 – All rights reserved 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 2. The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. 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. Annex H, “Guidance on risk management for in vitro diagnostic medical devices”, was prepared by ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. This second edition cancels and replaces the first edition (ISO 14971:2000) as well as the amendment ISO 14971:2000/Amd.1:2003. For purposes of future IEC maintenance, Subcommittee 62A has decided that the contents of this publication will remain unchanged until the maintenance result date1) indicated on the IEC web site under http://webstore.iec.ch in the data related to the specific publication. At this date, the publication will be ⎯ reconfirmed, ⎯ withdrawn, ⎯ replaced by a revised edition or ⎯ amended. This corrected version of ISO 14971:2007 incorporates the following correction: ⎯ a corrected version of Figure 1 on page 6.
1) IEC National Committees are requested to note that for this publication the maintenance result date is 2014. kSIST FprEN ISO 14971:2009
ISO 14971:2007(E) © ISO 2007 – All rights reserved vIntroduction The requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices. This International Standard was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this International Standard could be used as informative guidance in developing and maintaining a risk management system and process. This International Standard deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment. As a general concept, activities in which an individual, organization or government is involved can expose those or other stakeholders to hazards which can cause loss of or damage to something they value. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity. It is accepted that the concept of risk has two components: a) the probability of occurrence of harm; b) the consequences of that harm, that is, how severe it might be. The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public. All stakeholders need to understand that the use of a medical device entails some degree of risk. The acceptability of a risk to a stakeholder is influenced by the components listed above and by the stakeholder’s perception of the risk. Each stakeholder’s perception of the risk can vary greatly depending upon their cultural background, the socio-economic and educational background of the society concerned, the actual and perceived state of health of the patient, and many other factors. The way a risk is perceived also takes into account, for example, whether exposure to the hazard seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society. The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure. Such judgments should take into account the intended use, performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure or the circumstances of use. Some of these judgments can be made only by a qualified medical practitioner with knowledge of the state of health of an individual patient or the patient’s own opinion. As one of the stakeholders, the manufacturer makes judgments relating to safety of a medical device, including the acceptability of risks, taking into account the generally accepted state of the art, in order to determine the suitability of a medical device to be placed on the market for its intended use. This International Standard specifies a process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control. For any particular medical device, other International Standards could require the application of specific methods for managing risk.
kSIST FprEN ISO 14971:2009
kSIST FprEN ISO 14971:2009
INTERNATIONAL STANDARD ISO 14971:2007(E) © ISO 2007 – All rights reserved 1Medical devices — Application of risk management to medical devices 1 Scope This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply: 2.1 accompanying document document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the medical device, the operator or the user, particularly regarding safety NOTE Adapted from IEC 60601-1:2005, definition 3.4. 2.2 harm physical injury or damage to the health of people, or damage to property or the environment [ISO/IEC Guide 51:1999, definition 3.3] 2.3 hazard potential source of harm [ISO/IEC Guide 51:1999, definition 3.5] 2.4 hazardous situation circumstance in which people, property, or the environment are exposed to one or more hazard(s) [ISO/IEC Guide 51:1999, definition 3.6] NOTE See Annex E for an explanation of the relationship between “hazard” and “hazardous situation”. kSIST FprEN ISO 14971:2009
ISO 14971:2007(E) 2 © ISO 2007 – All rights reserved 2.5 intended use intended purpose use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer 2.6 in vitro diagnostic medical device IVD medical device medical device intended by the manufacturer for the examination of specimens derived from the human body to provide information for diagnostic, monitoring or compatibility purposes EXAMPLES Reagents, calibrators, specimen collection and storage devices, control materials and related instruments, apparatus or articles. NOTE 1 Can be used alone or in combination with accessories or other medical devices. NOTE 2 Adapted from ISO 18113-1:—, definition 3.29. 2.7 life-cycle all phases in the life of a medical device, from the initial conception to final decommissioning and disposal 2.8 manufacturer natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a medical device, assembling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether
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