IEC 62366:2007

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.

General Information

• Status: Withdrawn
• Publication Date: 12-Nov-2007
• Withdrawal Date: 12-Nov-2007
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: ISO/TC 210/JWG 3 - Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability
• Current Stage: 9599 - Withdrawal of International Standard
• Start Date: 25-Feb-2015
• Completion Date: 30-Oct-2025

Relations

• Amended By: IEC 62366:2007/Amd 1:2014 - Medical devices - Application of usability engineering to medical devices - Amendment 1
• Effective Date: 09-May-2020
• Revised: IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 01-Dec-2012

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
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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
– 2 – 62366 © IEC:2007
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

Bibliography.

Index of defined terms .

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

– 4 – 62366 © IEC:2007
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
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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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.
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.
– 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.
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]

– 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
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.

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.

– 10 – 62366 © IEC:2007
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.

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 repair; and
– disposal.
NOTE See also D.3.1.
Consider compliance with the requirements of this clause to exist when the criteria of the
relevant inspections and tests in this International Standard are achieved.
4.1.2 RESIDUAL RISK
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, for the purposes of ISO 14971, the RESIDUAL RISKS associated with
USABILITY of the MEDICAL DEVICE shall be presumed to be acceptable, unless there is OBJECTIVE
EVIDENCE to the contrary.
NOTE 1 Such OBJECTIVE EVIDENCE can subsequently originate from post-market surveillance.
NOTE 2 ISO 14971:2007, Subclause 6.6 requires that design changes resulting from the USABILITY ENGINEERING
PROCESS be reviewed to determine if other HAZARDS or HAZARDOUS SITUATIONS have been generated.
NOTE 3 ISO 14971:2007, Clause 7 requires that all RESIDUAL RISK be considered when evaluating the overall
RESIDUAL RISK of the MEDICAL DEVICE, including the RESIDUAL RISK associated with USABILITY of the MEDICAL DEVICE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

– 12 – 62366 © IEC:2007
4.1.3 Information for SAFETY
If information for SAFETY is used as a RISK CONTROL measure, the MANUFACTURER shall subject
this information to the USABILITY ENGINEERING PROCESS.
EXAMPLE 1 Warnings or limitation of use in the ACCOMPANYING DOCUMENT
EXAMPLE 2 Markings
Disregarding such information for SAFETY shall be considered beyond any further reasonable
means of RISK CONTROL. See also Annex B.
NOTE 1 Information for SAFETY is one element in a hierarchal approach to RISK CONTROL in which the
MANUFACTURER uses one or more of the following in the priority listed (see ISO 14971:2007, 6.2):
a) inherent SAFETY by design;
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS, e.g. ALARM SYSTEMS;
c) information for SAFETY, e.g. warnings in the instructions for use, display of a monitored variable, training and
materials for training, maintenance details.
NOTE 2 The need to include information for SAFETY can be an input to the USABILITY ENGINEERING PROCESS (e.g.
imposed by some other standard) or it can be discovered during the USABILITY ENGINEERING PROCESS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENT and the USABILITY
ENGINEERING FILE.
4.2 * USABILITY ENGINEERING FILE
The results of the USABILITY ENGINEERING PROCESS shall be recorded in the USABILITY
ENGINEERING FILE. The RECORDS and other documents that form the USABILITY ENGINEERING
FILE may form part of other documents and files.
EXAMPLE 1 MANUFACTURER’S product design file
EXAMPLE 2 RISK MANAGEMENT FILE
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
4.3 Scaling of the USABILITY ENGINEERING effort
The USABILITY ENGINEERING PROCESS may vary in form and extent based on the nature of the
MEDICAL DEVICE, its intended USER and its INTENDED USE (see D.3.2). In the case of the
modification of a MEDICAL DEVICE design, the USABILITY ENGINEERING PROCESS may be scaled-
up or scaled-down based on the significance of the modification as determined by the results
of the RISK ANALYSIS (see D.3.2.2).
NOTE 1 The MANUFACTURER should conduct iterative design and development. USABILITY ENGINEERING, including
USABILITY VALIDATION, should begin early and continue through the MEDICAL DEVICE design and development
lifecycle.
NOTE 2 Due to the iterative nature of the USABILITY ENGINEERING PROCESS, the activities described in Clause 5
can be carried out in any convenient order (see Clause D.2).
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5 * USABILITY ENGINEERING PROCESS
5.1 * Application specification
The MANUFACTURER shall specify the application of the MEDICAL DEVICE in the USABILITY
ENGINEERING FILE.
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This specification shall include:
– * intended medical indication;
EXAMPLE 1 Conditions(s) or disease(s) to be screened, monitored, treated, diagnosed, or prevented
– intended PATIENT population;
EXAMPLE 2 age
EXAMPLE 3 weight
EXAMPLE 4 health
EXAMPLE 5 condition
– intended part of the body or type of tissue applied to or interacted with;
– * intended USER PROFILE;
– * intended conditions of use; and
EXAMPLE 6 environment including hygienic requirements
EXAMPLE 7 frequency of use
EXAMPLE 8 location
EXAMPLE 9 mobility
– * operating principle.
NOTE Requirements for disclosing a summary of the MEDICAL DEVICE APPLICATION SPECIFICATION in the
ACCOMPANYING DOCUMENT are found in Clause 6.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.2 * Frequently used functions
The MANUFACTURER shall determine the frequently used functions that involve USER interaction
with the MEDICAL DEVICE and record them in the USABILITY ENGINEERING FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY
5.3.1 Identification of characteristics related to SAFETY
An identification of characteristics related to SAFETY (part of a RISK ANALYSIS) that focuses on
USABILITY shall be performed according to ISO 14971:2007, 4.2.
During the identification characteristics related to SAFETY, the following shall be considered:
– application specification, including USER PROFILE(S) (see 5.1); and
– frequently used functions (see 5.2).
SAFETY shall be recorded in the
The results of this identification characteristics related to
USABILITY ENGINEERING FILE.
NOTE 1 See also D.4.3, D.4.6.4, D.5.2, and D.5.4 for a discussion of methods that might be useful in identifying
characteristics related to SAFETY.
NOTE 2 See 4.3 for scaling of the USABILITY ENGINEERING effort.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

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5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
The MANUFACTURER shall identify known or foreseeable HAZARDS (part of a RISK ANALYSIS)
related to USABILITY according to ISO 14971:2007, 4.3. The identification of HAZARDS shall
consider HAZARDS to PATIENTS, USERS and other persons (see Annex E and Annex F).
Reasonably foreseeable sequences or combinations of events involving the USER INTERFACE
that can result in a HAZARDOUS SITUATION associated with the MEDICAL DEVICE shall be
identified. The SEVERITY of the resulting possible HARM shall be determined.
During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following shall be
considered:
– application specification, including USER PROFILE(S) (see 5.1);
– * task related requirements;
– * context of use;
– information on HAZARDS and HAZARDOUS SITUATIONS known for existing USER INTERFACES of
MEDICAL DEVICES of a similar type, if available;
– preliminary USE SCENARIOS;
– possible USE ERRORS (see C.2 for some examples of potential USE ERRORS);
– * if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a USE
ERROR resulting in a HAZARDOUS SITUATION; and
– * results of the review of the USER INTERFACE (see C.4 and D.2.2).
The results of this identification of HAZARDS, HAZARDOUS SITUATIONS and SEVERITY shall be
recorded in the USABILITY ENGINEERING FILE.
NOTE 1 See also D.5.9, D.5.14 and D.5.17 for a discussion of methods that might be useful in identifying known
or foreseeable HAZARDS or HAZARDOUS SITUATIONS.
NOTE 2 The identification of HAZARDS and HAZARDOUS SITUATIONS for the MEDICAL DEVICE or for the corresponding
generic device type is an input for the USABILITY SPECIFICATION as required for the USABILITY ENGINEERING PROCESS.
NOTE 3 During the identification of HAZARDS or HAZARDOUS SITUATIONS, ABNORMAL USE conditions can be
identified. See also C.1.
NOTE 4 The evaluation of post-production information (post-market surveillance) should include USABILITY (see
ISO 14971:2007, Clause 9).
NOTE 5 See 4.3 for scaling of the USABILITY ENGINEERING effort.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.4 PRIMARY OPERATING FUNCTIONS
The MANUFACTURER shall determine the PRIMARY OPERATING FUNCTIONS and record them in the
USABILITY ENGINEERING FILE.
The inputs to the PRIMARY OPERATING FUNCTIONS shall include the following:
– frequently used functions (see 5.2); and
– functions related to SAFETY of the MEDICAL DEVICE.
NOTE 1 See also D.5.7 for discussion of a method that might be useful in determining PRIMARY OPERATING
FUNCTIONS.
NOTE 2 See H.2.2 for an example of PRIMARY OPERATING FUNCTIONS for a hypothetical MEDICAL DEVICE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

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5.5 * USABILITY SPECIFICATION
The MANUFACTURER shall develop the USABILITY SPECIFICATION. The USABILITY SPECIFICATION
shall provide:
– testable requirements for USABILITY VERIFICATION; and
– testable requirements for USABILITY of the PRIMARY OPERATING FUNCTIONS including criteria
for determining the adequacy of RISK CONTROL achieved by the USABILITY ENGINEERING
PROCESS.
NOTE 1 Testable requirements for USABILITY of the PRIMARY OPERATING FUNCTIONS can be expressed as USABILITY
goals. For examples see Table D.5, Table D.6, and Annex G.
NOTE 2 The criteria for determining adequacy correspond to the criteria for RISK acceptability in ISO 14971:2007,
3.4 d).
NOTE 3 Guidance on the evaluation of the adequacy of RISK CONTROL measures can be found in ISO 14971:2007,
D.4.
The USABILITY SPECIFICATION shall be recorded in the USABILITY ENGINEERING FILE. The
USABILITY SPECIFICATION may be integrated into other specifications.
USABILITY SPECIFICATION shall include the following:
The inputs to the
– application specification (see 5.1);
– PRIMARY OPERATING FUNCTIONS (see 5.4);
– HAZARDS and HAZARDOUS SITUATIONS related to USABILITY (see 5.3); and
– known or foreseeable USE ERRORS associated with the MEDICAL DEVICE.
The USABILITY SPECIFICATION shall describe at least:
USE SCENARIOS related to the PRIMARY OPERATING FUNCTIONS, including;
–
– * frequent USE SCENARIOS; and
USE SCENARIOS;
– reasonably foreseeable worst case
– USER INTERFACE requirements for the PRIMARY OPERATING FUNCTIONS, including those to
mitigate RISK;
– requirements for determining whether PRIMARY OPERATING FUNCTIONS are easily
recognizable by the USER.
NOTE 3 See also D.2.6, D.3.3 and D.4.4 for guidance in preparing USABILITY SPECIFICATIONS.
NOTE 4 The USABILITY SPECIFICATION should describe the context of use (see the rationale for 5.3 and D.4.1.2.4).
NOTE 5 See Annex H for an example of a USABILITY SPECIFICATION for a hypothetical MEDICAL DEVICE.
NOTE 6 See 4.3 for scaling of the USABILITY ENGINEERING effort.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.6 USABILITY VALIDATION plan
The MANUFACTURER shall prepare and maintain a USABILITY VALIDATION plan. The USABILITY
VALIDATION plan shall specify:
– any method used for VALIDATION of the USABILITY of the PRIMARY OPERATING FUNCTIONS;
– the criteria for determining successful VALIDATION of the USABILITY of the PRIMARY
OPERATING FUNCTIONS based on the USABILITY SPECIFICATION; and
NOTE 1 The acceptance criteria for VALIDATION of the PRIMARY OPERATING FUNCTIONS correspond to the
criteria for RISK acceptability in ISO 14971:2007, 3.4 d).
– the involvement of representative intended USERS.

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USABILITY VALIDATION methods may be quantitative or qualitative. USABILITY VALIDATION may be
performed in a laboratory setting, in a simulated use environment or in the actual use
environment.
NOTE 2 See also D.4.4 and D.4.7.3 for guidance on preparing a USABILITY VALIDATION plan.
NOTE 3 The MANUFACTURER should apply one or more methods for the USABILITY VALIDATION of PRIMARY
OPERATING FUNCTIONS of the MEDICAL DEVICE depending on the INTENDED USE. Examples of these methods are
found in D.5.
NOTE 4 Findings based on any single method can be insufficient, e.g. in a clinical evaluation it might not be
possible to explore some high-RISK situations.
The USABILITY VALIDATION plan shall address:
– frequent USE SCENARIOS, and
USE SCENARIOS,
– reasonably foreseeable worst case
that are identified in the USABILITY SPECIFICATION.
NOTE 5 See 4.3 for scaling of the USABILITY ENGINEERING effort.
The USABILITY VALIDATION plan shall be recorded in the USABILITY ENGINEERING FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.7 * USER INTERFACE design and implementation
The MANUFACTURER shall design and implement the USER INTERFACE as described in the
USABILITY SPECIFICATION utilizing, as appropriate, USABILITY ENGINEERING methods and
techniques.
NOTE 1 See also D.4 and D.5 for guidance in preparing USER INTERFACE design and implementation.
NOTE 2 The MANUFACTURER should conduct iterative design and development. USABILITY ENGINEERING, including
USABILITY VALIDATION, should begin early and continue through the MEDICAL DEVICE design and development
lifecycle.
NOTE 3 In considering the options for RISK CONTROL, ISO 14971:2007, 6.2 requires that the MANUFACTURER uses
one or more of the following in the priority listed:
a) inherent SAFETY by design;
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS, e.g. ALARM SYSTEMS;
c) information for SAFETY, e.g. warnings in the instructions for use, display of a monitored variable, training and
materials for training, maintenance details.
Consider compliance with the requirements of this subclause to exist when the requirements
of 5.8 and 5.9 have been fulfilled.
5.8 * USABILITY VERIFICATION
As part of the MEDICAL DEVICE design VERIFICATION PROCESS, the MANUFACTURER shall VERIFY
the implementation of the MEDICAL DEVICE USER INTERFACE design against the requirements of
the USABILITY SPECIFICATION. The results of the VERIFICATION shall be recorded in USABILITY
ENGINEERING FILE.
NOTE 1 See also D.5.2, D.5.4, D.5.6, D.5.8 and D.5.15 for guidance on USABILITY VERIFICATION.
NOTE 2 See 4.3 for scaling of the USABILITY ENGINEERING effort.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

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5.9 * USABILITY VALIDATION
The MANUFACTURER shall VALIDATE USABILITY of the MEDICAL DEVICE according to the USABILITY
VALIDATION plan. The results shall be recorded in the USABILITY ENGINEERING FILE.
NOTE 1 See also D.5.13 and D.5.15 for guidance on performing a USABILITY VALIDATION.
NOTE 2 ISO 14971:2007, Subcl
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