SIST EN ISO 14971:2007
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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 ein Verfahren für den Hersteller eines Medizinprodukts zur Feststellung der mit Medizinprodukten einschließlich von Produkten für die In vitro-Diagnostik verbundenen Gefährdungen und Gefährdungssituationen fest; sie dient weiter seiner Einschätzung und Bewertung der Risiken, zur Kontrolle dieser Risiken und zur Überwachung der Wirksamkeit dieser Kontrolle.
Die Anforderungen dieser Internationalen Norm gelten während aller Stadien des Lebenszyklus eines Medizinprodukts.
Diese Internationale Norm gilt nicht für die klinische Entscheidungsfindung.
In dieser Norm werden keine vertretbaren Niveaus von Risiken festgelegt.
Diese Norm fordert nicht, dass der Hersteller über ein Qualitätsmanagementsystem verfügt. Das Risikomanagement kann jedoch ein fester Teil eines Qualitätsmanagementsystems sein
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007)
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2007)
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14971:2007
01-oktober-2007
1DGRPHãþD
SIST EN ISO 14971:2001
SIST EN ISO 14971:2001/A1:2003
SIST EN ISO 14971:2001/AC:2003
0HGLFLQVNLSULSRPRþNL8SRUDEDREYODGRYDQMDWYHJDQMDSULPHGLFLQVNLK
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Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2007)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2007)
Ta slovenski standard je istoveten z: EN ISO 14971:2007
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14971:2007 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
March 2007
ICS 11.040.01 Supersedes EN ISO 14971:2000
English Version
Medical devices - Application of risk management to medical
devices (ISO 14971:2007)
Dispositifs médicaux - Application de la gestion des risques Medizinprodukte - Anwendung des Risikomanagements auf
aux dispositifs médicaux (ISO 14971:2007) Medizinprodukte (ISO 14971:2007)
This European Standard was approved by CEN on 9 March 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14971:2007: E
worldwide for CEN national Members.
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EN ISO 14971:2007 (E)
Foreword
The text of the International Standard ISO/FDIS 14971:2006 has been prepared by Technical
Committee ISO/TC 210 "Quality management and corresponding general aspects for medical
devices, Joint Working Group 1". The transposition into a European Standard has been
managed by the CEN Management Centre (CMC) with the assistance of the CEN Advisory
Board for Health Standards.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by September 2007, and conflicting national
standards shall be withdrawn at the latest by September 2007.
This document supersedes EN ISO 14971:2000.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with Essential Requirements in EU Directive(s), see informative Annex ZA,
which is an integral part of this document.
The present standard can also be used to support some parts of the conformity assessment
procedures described in annexes of the European medical devices directives (90/385/EEC,
93/42/EEC and (98/79/EC):
− an adequate description of: results of the risk analysis,
− an undertaking by the manufacturer to institute and keep up to date a systematic procedure
to review experience gained from devices in the post-production phase and to implement
appropriate means to apply any necessary corrective action
NOTE: Other requirements may be applicable to this aspect
In establishing the policy for determining risk acceptability criteria, this standard allows
manufacturers to choose from a range of options within those permitted by regulations (see
clause 3.2). European medical devices directives require that, in selecting the most appropriate
solutions for the design and construction of the devices, these solutions must conform to safety
principles, taking account of the generally acknowledged state of the art, and the manufacturer
must apply the following principles in the following order:
• eliminate or reduce risks as far as possible (inherently safe design and construction),
• where appropriate take adequate protection measures including alarms if necessary, in
relation to risks that cannot be eliminated,
• inform users of the residual risks due to any shortcomings of the protection measures
adopted.
In this context, ‘eliminating’ or ‘reducing’ risk must be interpreted and applied in such a way as to
take account of technology and practice existing at the time of design and of technical and
economical considerations compatible with a high level of protection of health and safety; (see
also Annex D.8).
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Endorsement notice
The text of ISO 14971:2007 has been approved by CEN as EN ISO 14971:2007 without any
modifications.
2
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EN ISO 14971:2007 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directives 93/42/EEC Medical Devices,
90/385/EEC Active Implantable Medical Devices and 98/79/EC In
Vitro Diagnostic Devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the clauses of this standard confers, within the limits of the scope of this
standard, a presumption of conformity with the corresponding Essential Requirements of that
Directive and associated EFTA regulations.
Because this standard describes an ongoing process it is not possible to link individual clauses
to specific corresponding Essential Requirements. This standard provides a process for
managing risks associated with medical devices. Compliance with all the requirement clauses in
this standard will ensure that general aspects of medical devices related to risk and safety have
been addressed. For particular medical devices or for particular safety aspects, additional
specific requirements may need to be complied with in order to meet the essential requirements.
Relevant harmonized standards may be used for this purpose. The risk management processes
described in this standard could establish the need for collection of clinical or other experimental
data. It does not describe how this has to be carried out. Relevant harmonized standards may
be used for this purpose.
WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
3
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INTERNATIONAL ISO
STANDARD 14971
Second edition
2007-03-01
Medical devices — Application of risk
management to medical devices
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
Reference number
ISO 14971:2007(E)
©
ISO 2007
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ISO 14971:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 14971:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 General requirements for risk management . 5
3.1 Risk management process . 5
3.2 Management responsibilities . 7
3.3 Qualification of personnel . 7
3.4 Risk management plan. 7
3.5 Risk management file. 8
4 Risk analysis . 8
4.1 Risk analysis process . 8
4.2 Intended use and identification of characteristics related to the safety of the medical
device. 9
4.3 Identification of hazards . 9
4.4 Estimation of the risk(s) for each hazardous situation. 9
5 Risk evaluation. 10
6 Risk control . 11
6.1 Risk reduction . 11
6.2 Risk control option analysis. 11
6.3 Implementation of risk control measure(s). 11
6.4 Residual risk evaluation. 12
6.5 Risk/benefit analysis . 12
6.6 Risks arising from risk control measures.12
6.7 Completeness of risk control . 12
7 Evaluation of overall residual risk acceptability . 13
8 Risk management report. 13
9 Production and post-production information. 13
Annex A (informative) Rationale for requirements . 15
Annex B (informative) Overview of the risk management process for medical devices . 23
Annex C (informative) Questions that can be used to identify medical device characteristics that
could impact on safety. 25
Annex D (informative) Risk concepts applied to medical devices. 32
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous
situations . 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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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.
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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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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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 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”.
© ISO 2007 – All rights reserved 1
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ISO 14971:2007(E)
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 these operations are carried out by that person or on that person's behalf by a third
party
NOTE 1 Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of
manufacturer.
NOTE 2 For a definition of labelling, see ISO 13485:2003, definition 3.6.
2.9
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the specific purpose(s) of
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease,
⎯ diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
⎯ investigation, replacement, modification, or support of the anatomy or of a physiological process,
⎯ supporting or sustaining life,
⎯ control of conception,
⎯ disinfection of medical devices,
⎯ providing information for medical purposes by means of in vitro examination of specimens derived from
the human body,
and which does not achieve its primary 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
NOTE 1 This definition has been developed by the Global Harmonization Task Force (GHTF). See bibliographic
reference [38].
[ISO 13485:2003, definition 3.7]
2 © ISO 2007 – All rights reserved
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ISO 14971:2007(E)
NOTE 2 Products, which could be considered to be medical devices in some jurisdictions but for which there is not yet
a harmonized approach, are:
⎯ aids for disabled/handicapped people,
⎯ devices for the treatment/diagnosis of diseases and injuries in animals,
⎯ accessories for medical devices (see Note 3),
⎯ disinfection substances,
⎯ devices incorporating animal and human tissues which can meet the requirements of the above definition but are
subject to different controls.
NOTE 3 Accessories intended specifically by manufacturers to be used together with a “parent” medical device to
enable that medical device to achieve its intended purpose, should be subject to this International Standard.
2.10
objective evidence
data supporting the existence or verity of something
NOTE Objective evidence can be obtained through observation, measurement, testing or other means.
[ISO 9000:2005, definition 3.8.1]
2.11
post-production
part of the life-cycle of the product after the design has been completed and the medical device has been
manufactured
EXAMPLES transportation, storage, installation, product use, maintenance, repair, product changes,
decommissioning and disposal.
2.12
procedure
specified way to carry out an activity or a process
[ISO 9000:2005, definition 3.4.5]
2.13
process
set of interrelated or interacting activities which transforms inputs into outputs
[ISO 9000:2005, definition 3.4.1]
2.14
record
document stating results achieved or providing evidence of activities performed
[ISO 9000:2005, definition 3.7.6]
2.15
residual risk
risk remaining after risk control measures have been taken
NOTE 1 Adapted from ISO/IEC Guide 51:1999, definition 3.9.
NOTE 2 ISO/IEC Guide 51:1999, definition 3.9 uses the term “protective measures” rather than “risk control
measures.” However, in the context of this International Standard, “protective measures” are only one option for controlling
risk as described in 6.2.
© ISO 2007 – All rights reserved 3
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ISO 14971:2007(E)
2.16
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO/IEC Guide 51:1999, definition 3.2]
2.17
risk analysis
systematic use of available information to identify hazards and to estimate the risk
[ISO/IEC Guide 51:1999, definition 3.10]
NOTE Risk analysis includes examination of different sequences of events that can produce hazardous situations
and harm. See Annex E.
2.18
risk assessment
overall process comprising a risk analysis and a risk evaluation
[ISO/IEC Guide 51:1999, definition 3.12]
2.19
risk control
process in which decisions are made and measures implemented by which risks are reduced to, or
maintained within, specified levels
2.20
risk estimation
process used to assign values to the probability of occurrence of harm and the severity of that harm
2.21
risk evaluation
process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
2.22
risk management
systematic application of management policies, procedures and practices to the tasks of analysing, evaluating,
controlling and monitoring risk
2.23
risk management file
set of records and other documents t
...
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