SIST EN ISO 14971:2001
(Main)Medical devices - Application of risk management to medical devices (ISO 14971:2000)
Medical devices - Application of risk management to medical devices (ISO 14971:2000)
Migrated from Progress Sheet (TC Comment) (2000-07-10): This is now a CEN CLC joint vote at FV the only reference for this doc is EN ISO ++ 14971 (tv 1999-12-22) ++ Attention - contact Mr Vyze ext 850 when processing this document
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2000)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2000)
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14971:2001
01-november-2001
1DGRPHãþD
SIST EN 1441:2000
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
SULSRPRþNLK ,62
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
SIST EN ISO 14971:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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Page 2
EN ISO 14971:2000
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.
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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
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ISO 14971:2000(E)
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ii © ISO 2000 – All rights reserved
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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 2000 – All rights reserved iii
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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
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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 something they value. Risk management is a
complex subject because each stakeholder places a different value on the probability of harm occurring and on the
detriment that might be suffered on exposure to a hazard.
It is accepted that the concept of risk has two components:
a) the probability of the occurrence of harm, that is, how often the harm may occur;
b) the consequences of that harm, that is, how severe it might be.
The acceptability of a risk to a stakeholder is influenced by these components and by the stakeholder’s perception
of the risk.
These concepts 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. Factors affecting
each stakeholder’s perception of the risks include the socio-economic and educational background of the society
concerned and the actual and perceived state of health of the patient. The way a risk is perceived also takes into
account, for example, whether exposure to the risk 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 embark upon a clinical procedure utilizing a medical device requires the residual risks to be balanced
against the anticipated benefits of the procedure. Such judgements should take into account the intended
use/intended purpose, 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 judgements may 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 should make judgements relating to the 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 probable suitability of a medical device to be placed on the market for its intended use/intended purpose. This
International Standard specifies a procedure by which the manufacturer of a medical device can identify hazards
associated with a medical device and its accessories, estimate and evaluate the risks associated with those
hazards, control those risks and monitor the effectiveness of that control.
For any particular medical device, other International Standards may require the application of specific methods for
controlling risk.
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INTERNATIONAL STANDARD ISO 14971:2000(E)
Medical devices — Application of risk management to medical
devices
1 Scope
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with
medical devices and their accessories, including in vitro diagnostic medical devices, estimate and evaluate the
risks, control these risks and monitor the effectiveness of the control.
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 judgements relating to the use of a medical device.
It does not specify acceptable risk levels.
This International Standard does not require that the manufacturer has a formal quality system in place. However,
risk management can be an integral part of a quality system (see, for example, Table G.1).
2 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
2.1
accompanying document
document accompanying a medical device, or an accessory, and containing important information for the user,
operator, installer or assembler of the medical device particularly regarding safety
NOTE Based on IEC 60601-1:1988, definition 2.1.4.
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 3.1]
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]
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ISO 14971:2000(E)
2.5
intended use/intended purpose
use of a product, process or service in accordance with the specifications, instructions and information provided by
the manufacturer
2.6
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 and/or put into service,
regardless of whether these operations are carried out by that person himself or on his behalf by a third party
2.7
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the
software necessary for its proper application, intended by the manufacturer to be used for human beings for the
purpose of
� diagnosis, prevention, monitoring, treatment or alleviation of disease,
� diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap,
� investigation, replacement or modification of the anatomy or of a physiological process,
� control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[ISO 13485:1996, definition 3.1]
2.8
objective evidence
information which can be proven true, based on facts obtained through observation, measurement, test or other
means
[ISO 8402:1994, definition 2.19]
2.9
procedure
specific way to perform an activity
[ISO 8402:1994, definition 1.3]
2.10
process
set of inter-related resources and activities which transform inputs into outputs
[ISO 8402:1994, definition 1.2]
2.11
record
document which furnishes objective evidence of activities performed or results achieved
[ISO 8402:1994, definition 3.15]
2.12
residual risk
risk remaining after protective measures have been taken
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ISO 14971:2000(E)
[ISO/IEC Guide 51:1999, definition 3.9]
2.13
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO/IEC Guide 51:1999, definition 3.2]
2.14
risk analysis
systematic use of available information to identify hazards and to estimate the risk
[ISO/IEC Guide 51:1999, definition 3.10]
2.15
risk assessment
overall process comprising a risk analysis and a risk evaluation
[ISO/IEC Guide 51:1999, definition 3.12]
2.16
risk control
process through which decisions are reached and protective measures are implemented for reducing risks to, or
maintaining risks within, specified levels
2.17
risk evaluation
judgement, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context
based on the current values of society
NOTE Based on ISO/IEC Guide 51: 1999, definitions 3.11 and 3.7.
2.18
risk management
systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and
controlling risk
2.19
risk management file
set of records and other documents, not necessarily contiguous, that are produced by a risk management process
2.20
safety
freedom from unacceptable risk
[ISO/IEC Guide 51:1999, definition 3.1]
2.21
severity
measure of the possible consequences of a hazard
2.22
verification
confirmation by examination and provision of objective evidence that specified requirements have been fulfilled
NOTE In design and development, verification concerns the process of examining the result of a given activity to determine
conformity with the stated requirement for that activity.
[ISO 8402:1994, definition 2.17]
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ISO 14971:2000(E)
3 General requirements for risk management
3.1 National or regional regulatory requirements
Because of the wide variety of medical devices covered by this International Standard and the different national or
regional regulatory requirements covering those devices, the requirements given in 3.3 and 3.4 apply as
appropriate.
3.2 Risk management process
The manufacturer shall establish and maintain a process for identifying hazards associated with a medical device,
estimating and evaluating the associated risks, controlling these risks and monitoring the effectiveness of the
control. This process shall be documented and shall include the following elements:
� risk analysis;
� risk evaluation;
� risk control; and
� post-production information.
Where a documented product design/development process exists, it shall incorporate the appropriate parts of the
risk management process.
NOTE 1 A documented product design/development process can be used to deal with safety in a systematic manner, in
particular to enable the early identification of hazards in complex systems and environments.
NOTE 2 A schematic representation of the risk management process is shown in Figure 1.
NOTE 3 See the bibliography.
Compliance is checked by inspection of the risk management file.
3.3 Management responsibilities
The manufacturer shall
a) define the policy for determining acceptable risk, taking into account relevant International Standards, and
national or regional regulations,
b) ensure the provision of adequate resources,
c) ensure the assignment of trained personnel (see 3.4) for management, performance of work and assessment
activities, and
d) review the results of risk management activities at defined intervals to ensure continuing suitability and the
effectiveness of the risk management process.
The above shall be documented in the risk management file.
Compliance is checked by inspection of the risk management file.
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ISO 14971:2000(E)
Figure 1 — Schematic representation of the risk management process
3.4 Qualification of personnel
The manufacturer shall ensure that those performing risk management tasks include persons with knowledge and
experience appropriate to the tasks assigned to them. This shall include, where appropriate, knowledge and
experience of the medical device and its use and risk management techniques. Records of the appropriate
qualifications shall be maintained.
Compliance is checked by inspection of the appropriate records.
3.5 Risk management plan
For the particular medical device or accessory being considered, the manufacturer shall prepare a risk
management plan in accordance with the risk management process. The risk management plan shall be part of the
risk management file.
This plan shall include the following:
a) the scope of the plan, identifying and describing the medical device and the life cycle phases for which the plan
is applicable;
b) a verification plan;
c) allocation of responsibilities;
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ISO 14971:2000(E)
d) requirements for review of risk management activities; and
e) criteria for risk acceptability.
NOTE The criteria for risk acceptability will do much to determine the ultimate effectiveness of the risk management
process. Refer to annex E for guidance on establishing such criteria.
If the plan changes during the life cycle of the medical device, a record of the changes shall be maintained in the
risk management file.
Compliance is checked by inspection of the risk management file.
3.6 Risk management file
For the particular medical device or accessory being considered, the results of all risk management activities shall
be recorded and maintained in the risk management file.
NOTE 1 The records and other documents that make up the risk management file can form part of other documents and files
required, for example, by a manufacturer’s quality management system.
NOTE 2 The risk management file need not physically contain all the documents relating to this International Standard.
However, it should contain at least references or pointers to all required documentation. The manufacturer should be able to
assemble the information referenced in the risk management file in a timely fashion.
4Riskanalysis (Steps 1, 2 and 3 of Figure 2)
4.1 Risk analysis procedure
Risk analysis, as described in 4.2 to 4.4, shall be performed and the conduct and results of the risk analysis shall
be recorded in the risk management file.
NOTE If a risk analysis is available for a similar medical device, it may be used as a reference provided it can be
demonstrated that the processes are similar or that the changes that have been made will not introduce significant differences in
results. This should be based on a systematic evaluation of the changes and the ways they can influence the various hazards
present.
In addition to the records required in 4.2 to 4.4, the documentation of the conduct and results of the risk analysis
shall include at least the following:
a) a description and identification of the medical device or accessory that was analysed;
b) identification of the person(s) and organization which carried out the risk analysis;
c) date of the analysis.
Compliance is checked by inspection of the risk management file.
4.2 Intended use/intended purpose and identification of characteristics related to the safety of
the medical device (Step 1)
For the particular medical device or accessory being considered, the manufacturer shall describe the intended
use/intended purpose and any reasonably foreseeable misuse. The manufacturer shall list all those qualitative and
quantitative characteristics that could affect the safety of the medical device and, where appropriate, their defined
limits (see Note 1). These records shall be maintained in the risk management file.
NOTE 1 Annex A contains questions that can serve as a useful guide in drawing up such a list.
NOTE 2 Additional guidance on risk analysis techniques for in vitro diagnostic medical devices is given in annex B.
NOTE 3 Additional guidance on risk analysis techniques for toxicological hazards is given in annex C.
Compliance is checked by inspection of the risk management file.
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ISO 14971:2000(E)
Figure 2 — Overview of risk management activities as applied to medical devices
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ISO 14971:2000(E)
4.3 Identification of known or foreseea
...
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