ISO 14971:2000

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 2000
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ii © ISO 2000 – All rights reserved

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
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

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.
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,
...