IEC 62366:2007
(Main)Medical devices — Application of usability engineering to medical devices
Medical devices — Application of usability engineering to medical devices
Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.
Dispositifs médicaux — Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
Spécifie un processus permettant à un fabricant d'analyser, de spécifier, de concevoir, de vérifier et de valider l'aptitude à l'utilisation concernant la sécurité d'un dispositif médical. Ce processus d'ingénierie de l'aptitude à l'utilisation évalue et réduit les risques provoqués par les problèmes d'aptitude à l'utilisation associés à une utilisation correcte et à des erreurs d'utilisation, c'est-à-dire une utilisation normale. Il peut être utilisé pour identifier mais n'évalue pas et ne réduit pas les risques associés à une utilisation anormale. Si le processus d'ingénierie de l'aptitude à l'utilisation détaillé dans la présente Norme internationale a été satisfait et si les critères d'acceptation documentés dans le plan de validation de l'aptitude à l'utilisation ont été satisfaits, les risques résiduels définis dans l'ISO 14971 associés à l'aptitude à l'utilisation d'un dispositif médical sont alors présumés acceptables, sauf s'il existe une preuve tangible du contraire. La présente Norme internationale ne s'applique pas à la prise de décision clinique relative à l'utilisation d'un dispositif médical.
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Standards Content (Sample)
IEC 62366
Edition 1.0 2007-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices – Application of usability engineering to medical devices
Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
IEC 62366:2007
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IEC 62366
Edition 1.0 2007-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices – Application of usability engineering to medical devices
Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XD
CODE PRIX
ICS 11.040 ISBN 2-8318-9313-5
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CONTENTS
FOREWORD.4
INTRODUCTION.6
1 * Scope .7
2 Normative references .7
3 Terms and definitions .7
4 * Principles.11
4.1 General requirements.11
4.1.1 * USABILITY ENGINEERING PROCESS .11
4.1.2 RESIDUAL RISK .11
4.1.3 Information for SAFETY .12
4.2 * USABILITY ENGINEERING FILE .12
4.3 Scaling of the USABILITY ENGINEERING effort.12
5 * USABILITY ENGINEERING PROCESS.12
5.1 * Application specification.12
5.2 * Frequently used functions .13
5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY .13
5.3.1 Identification of characteristics related to SAFETY .13
5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS
SITUATIONS.14
5.4 PRIMARY OPERATING FUNCTIONS .14
5.5 * USABILITY SPECIFICATION .15
5.6 USABILITY VALIDATION plan.15
5.7 * USER INTERFACE design and implementation .16
5.8 * USABILITY VERIFICATION.16
5.9 * USABILITY VALIDATION.17
6 * ACCOMPANYING DOCUMENT .17
7 * Training and materials for training.18
Annex A (informative) General guidance and rationale.19
Annex B (informative) Categories of USER action.31
Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes.33
Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS.36
ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE
characteristics associated with USABILITY that could impact on SAFETY.60
ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS.64
Annex G (informative) USABILITY goals: Illustrative example for a home parenteral
infusion pump .67
ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs .77
Annex I (informative) Recommended reading list .87
Annex J (informative) Reference to the essential principles .95
96
Bibliography.
98
Index of defined terms .
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62366 © IEC:2007 – 3 –
Figure A.1 – A comparison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the
USABILITY ENGINEERING PROCESS (IEC 62366) .24
Figure B.1 – Categories of foreseeable USER action.32
Figure D.1 – A USER INTERFACE design cycle .39
Figure D.2 – Bubble diagram of the conceptual model of a physiological monitor.52
Figure F.1 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM .65
Table D.1 – Sample of design flaws and associated USE ERRORS .37
Table D.2 – Mapping of Figure D.1 to the subclauses of this International Standard .39
Table D.3 – Examples of USER INTERFACE requirements .42
Table D.4 – Typical deliverables .47
Table D.5 – Examples of objective USABILITY goals .50
Table D.6 – Examples of subjective USABILITY goals.50
Table D.7 – Examples of USER INTERFACE modelling techniques .53
Table D.8 – Characteristics of a typical USABILITY testing effort .53
Table F.1 – Glossary of relevant RISK MANAGEMENT terms .64
Table F.2 – Examples of HARM due to USABILITY related HAZARDS.65
Table G.1 – Power on/off .70
Table G.2 – Program pump.70
Table G.3 – Start/stop infusion.71
Table G.4 – Monitor infusion status.72
Table G.5 – Install and change set.72
Table G.6 – Priming.73
a
Table G.7 – Respond to and inactivate ALARM SIGNALS .73
Table G.8 – Lockouts.74
Table G.9 – Power management.74
Table G.10 – Preventative and routine maintenance .75
Table G.11 – Basic operation.76
Table G.12 – Advanced functions .76
Table J.1 – Correspondence between this document and the essential principles .95
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
______________
MEDICAL DEVICES –
APPLICATION OF USABILITY ENGINEERING
TO MEDICAL DEVICES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any medical
device declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62366 has been prepared by a joint working group of
subcommittee 62A: Common aspects of electrical medical equipment used in medical
practice, of IEC technical committee 62: Electrical medical equipment in medical practice and
technical committee ISO/TC 210: Quality management and corresponding general aspects for
medical devices.
It is published as double logo standard.
The text of this standard is based on the following documents:
FDIS Report of voting
62A/574/FDIS 62A/579/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 20 P-members
out of 20 having cast a vote.
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62366 © IEC:2007 – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this International Standard, the following print types are used:
– Requirements and definitions: roman type.
– Means to assess compliance: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type
– TERMS DEFINED IN CLAUSE 3 OR AS NOTED: SMALL CAPITALS.
The requirements are followed by means to assess compliance.
Clause and subclauses for which a rationale is provided in informative Annex A are marked
with an asterisk (*).
The committee has decided that the contents of this publication will 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.
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– 6 – 62366 © IEC:2007
INTRODUCTION
Medical practice is increasingly using MEDICAL DEVICES for observation and treatment of
PATIENTS. USE ERRORS caused by inadequate MEDICAL DEVICE USABILITY have become an
increasing cause for concern. Many of the MEDICAL DEVICES developed without applying a
USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to use. As healthcare
evolves, less skilled USERS including PATIENTS themselves are now using MEDICAL DEVICES and
MEDICAL DEVICES are becoming more complicated. In simpler times, the USER of a MEDICAL
DEVICE might be able to cope with an ambiguous, difficult-to-use USER INTERFACE. The design
of a usable MEDICAL DEVICE is a challenging endeavour, yet many organizations treat it as if it
were just “common sense”. The design of the USER INTERFACE to achieve adequate (safe)
USABILITY requires a very different skill set than that of the technical implementation of that
interface.
The USABILITY ENGINEERING PROCESS is intended to achieve reasonable USABILITY, which in
turn is intended to minimise USE ERRORS and to minimise use-associated RISKS. Some, but not
all, forms of incorrect use are amenable to control by the MANUFACTURER. The USABILITY
ENGINEERING PROCESS is related to the RISK MANAGEMENT PROCESS as indicated in Figure A.1.
This International Standard describes a USABILITY ENGINEERING PROCESS, and provides
guidance on how to implement and execute the PROCESS to provide SAFETY in MEDICAL
DEVICES. It is intended to be useful not only for MANUFACTURERS of MEDICAL DEVICES, but also
for technical committees responsible for the preparation of particular MEDICAL DEVICE
standards.
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62366 © IEC:2007 – 7 –
MEDICAL DEVICES –
APPLICATION OF USABILITY ENGINEERING
TO MEDICAL DEVICES
1 * Scope
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify,
design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This
USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems
associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but
does not assess or mitigate RISKS associated with ABNORMAL USE.
NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE.
If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been
complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have
been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with
USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE
EVIDENCE to the contrary (see 4.1.2).
This International Standard does not apply to clinical decision-making relating to the use of a
MEDICAL DEVICE.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
NOTE Informative references are listed in the bibliography beginning on page 96.
ISO 14971:2007, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purpose of this document, the terms and definitions given in ISO 14971:2007 and the
following apply.
NOTE An index of defined terms is found beginning on page 98.
3.1
ABNORMAL USE
intentional act or intentional omission of an act by the RESPONSIBLE ORGANIZATION or USER of a
MEDICAL DEVICE as a result of conduct that is beyond any further reasonable means of RISK
CONTROL by the MANUFACTURER
NOTE 1 See also 4.1.3 and Annex B. Examples are given in Annex C.
NOTE 2 It is possible for the PATIENT to be the USER, e.g. when the MEDICAL DEVICE is used in the PATIENT’S home.
3.2
ACCOMPANYING DOCUMENT
document accompanying a MEDICAL DEVICE and containing information for those accountable
for the installation, use and maintenance of the MEDICAL DEVICE or the USER, particularly
regarding SAFETY
[ISO 14971:2007, definition 2.1, modified]
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– 8 – 62366 © IEC:2007
3.3
ALARM LIMIT
threshold used by an ALARM SYSTEM to determine an ALARM CONDITION
[IEC 60601-1-8:2006, definition 3.3]
NOTE This term is only used in notes and informative annexes.
3.4
ALARM OFF
state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not
generate ALARM SIGNALS
[IEC 60601-1-8:2006, definition 3.4]
NOTE This term is only used in notes and informative annexes.
3.5
ALARM SIGNAL
type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an
ALARM CONDITION
[IEC 60601-1-8:2006, definition 3.9]
NOTE This term is only used in notes and informative annexes.
3.6
ALARM SYSTEM
parts of the MEDICAL DEVICE that detect ALARM CONDITIONS and, as appropriate, generate ALARM
SIGNALS
[IEC 60601-1-8:2006, definition 3.11, modified]
NOTE This term is only used in notes and informative annexes.
3.7
CORRECT USE
NORMAL USE without USE ERROR
3.8
EFFECTIVENESS
measure of accuracy and completeness with which USERS achieve specified goals
[ISO 9241-11:1998, definition 3.2, modified]
NOTE This is a different concept than the 'clinical effectiveness'.
3.9
EFFICIENCY
EFFECTIVENESS in relation to the resources expended
3.10
INFORMATION SIGNAL
any signal that is not an ALARM SIGNAL or a REMINDER SIGNAL
EXAMPLE 1 ECG waveform
EXAMPLE 2 SpO tone
2
EXAMPLE 3 Fluoroscopy beam-on indication
[IEC 60601-1-8:2006, definition 3.23]
NOTE This term is only used in notes and informative annexes.
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62366 © IEC:2007 – 9 –
3.11
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 can be assisted in its function
by such means.
[ISO 13485:2003, definition 3.7]
3.12
* NORMAL USE
operation, including routine inspection and adjustments by any USER, and stand-by, according
to the instructions for use or in accordance with generally accepted practice for those MEDICAL
DEVICES provided without instructions for use
[IEC 60601-1:2005, definition 3.71, modified]
NOTE 1 USE ERROR can occur in NORMAL USE.
NOTE 2 MEDICAL DEVICES that can be used safely without instructions for use are exempted from having
instructions for use by some authorities with jurisdiction.
3.13
* PATIENT
living being (person) undergoing a medical, surgical or dental procedure
[IEC 60601-1:2005, definition 3.76, modified]
3.14
* PRIMARY OPERATING FUNCTION
function that involves USER interaction that is either frequently used or related to the SAFETY of
MEDICAL DEVICE
the
3.15
REMINDER SIGNAL
periodic signal that reminds the USER that the ALARM SYSTEM is in an ALARM SIGNAL-inactivation
state
[IEC 60601-1-8:2006, definition 3.34, modified]
NOTE This term is only used in notes and informative annexes.
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3.16
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL DEVICE or combination of MEDICAL
DEVICES
NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a lay person. In home
use applications, the PATIENT, USER and RESPONSIBLE ORGANIZATION can be one and the same person.
NOTE 2 Education and training is included in "use."
[IEC 60601-1:2005, definition 3.101, modified]
3.17
* USABILITY
characteristic of the USER INTERFACE that establishes EFFECTIVENESS, EFFICIENCY, ease of
USER learning and USER satisfaction
3.18
USABILITY ENGINEERING
application of knowledge about human behaviour, abilities, limitations, and other
characteristics related to the design of tools, devices, systems, tasks, jobs, and environments
to achieve adequate USABILITY
3.19
* USABILITY ENGINEERING FILE
set of RECORDS and other documents that are produced by the USABILITY ENGINEERING
PROCESS
3.20
USABILITY SPECIFICATION
documentation defining the USER INTERFACE requirements related to USABILITY
3.21
USE ERROR
act or omission of an act that results in a different MEDICAL DEVICE response than intended by
the MANUFACTURER or expected by the USER
NOTE 1 USE ERROR includes slips, lapses, and mistakes.
NOTE 2 See also Annex B and D.1.3.
NOTE 3 An unexpected physiological response of the PATIENT is not in itself considered USE ERROR.
3.22
USE SCENARIO
specified sequence of events and tasks as performed by a specified USER in a specified
environment
3.23
* USER
person using, i.e. operating or handling, the MEDICAL DEVICE
NOTE 1 This includes, but is not limited to, cleaners, maintainers and installers.
NOTE 2 PATIENTS or other laypersons can be USERS.
3.24
* USER INTERFACE
USER and the MEDICAL DEVICE interact
means by which the
[ANSI/AAMI/HE 74:2001, definition 3.24, modified]
NOTE The ACCOMPANYING DOCUMENT is considered part of the MEDICAL DEVICE and its USER INTERFACE.
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62366 © IEC:2007 – 11 –
3.25
USER PROFILE
summary of the mental, physical and demographic traits of an intended USER population, as
well as any special characteristics that can have a bearing on design decisions, such as
occupational skills and job requirements
3.26
VALIDATION
confirmation, through the provision of OBJECTIVE EVIDENCE, that the requirements for a specific
INTENDED USE or application have been fulfilled
NOTE 1 The term “VALIDATED” is used to designate the corresponding status.
NOTE 2 The use conditions for VALIDATION can be real or simulated.
[ISO 9000:2000, definition 3.8.5]
4 * Principles
4.1 General requirements
4.1.1 * USABILITY ENGINEERING PROCESS
The MANUFACTURER shall establish, document and maintain a USABILITY ENGINEERING PROCESS
to provide SAFETY for the PATIENT, USER and others related to USABILITY. The PROCESS shall
address USER interactions with the MEDICAL DEVICE according to the ACCOMPANYING DOCUMENT,
including, but not limited to:
– * transport;
– * storage;
– installation;
– operation;
– maintenance and
...
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