IEC 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS 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. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

Dispositifs médicaux — Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

L'IEC 62366-1:2015 spécifie un PROCESSUS permettant à un FABRICANT d'analyser, de spécifier, de développer et d'évaluer l'APTITUDE A l'UTILISATION d'un DISPOSITIF MEDICAL, concernant la SECURITE. Ce PROCESSUS D'INGENIERIE DE L'APTITUDE A L'UTILISATION (INGENIERIE DES FACTEURS HUMAINS) permet au FABRICANT d'évaluer et de réduire les RISQUES associés à une UTILISATION CORRECTE et à des ERREURS d'UTILISATION, c'est-à-dire une UTILISATION NORMALE. Il peut être utilisé pour identifier les RISQUES associés à une UTILISATION ANORMALE mais ne les évalue pas et ne les réduit pas. La première édition de l'IEC 62366-1, ainsi que la première édition de l'IEC 62366-2, annule et remplace la première édition de l'IEC 62366 parue en 2007 et son Amendement 1 (2014). La Partie 1 a été mise à jour afin d'inclure des concepts contemporains d'INGENIERIE DE L'APTITUDE A L'UTILISATION, tout en rationalisant le processus. Elle renforce aussi les liens avec l'ISO 14971:2007 et les méthodes connexes de GESTION DES RISQUES appliquées aux aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX. La Partie 2 contient des informations didactiques pour aider les fabricants à se conformer à la Partie 1 et fournit des descriptions plus détaillées des méthodes d'INGENIERIE DE L'APTITUDE A L'UTILISATION QUI PEUVENT ETRE APPLIQUEES D'UNE FAÇON PLUS GENERALE AUX DISPOSITIFS MEDICAUX et qui vont au-delà des aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX.

General Information

• Status: Published
• Publication Date: 24-Feb-2015
• 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: 9093 - International Standard confirmed
• Start Date: 03-Jun-2021
• Completion Date: 30-Oct-2025

Relations

• Revises: IEC 62366:2007/Amd 1:2014 - Medical devices - Application of usability engineering to medical devices - Amendment 1
• Effective Date: 12-Feb-2014
• Revises: IEC 62366:2007 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 01-Dec-2012

Overview

IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices - defines a usability engineering (human factors) process for manufacturers to analyse, specify, develop and evaluate the usability of medical devices as it relates to safety. The standard focuses on normal use and use errors, provides a streamlined, contemporary process, and reinforces links to ISO 14971 risk management for safety‑related user interfaces. Part 2 (separate) offers tutorial guidance and extended methods.

Key Topics

• Scope and principles: Usability engineering applied where user‑interface design affects device safety; tailoring effort to device risk and complexity.
• Usability engineering process (Clause 5):
  • Prepare a use specification
  • Identify user‑interface characteristics related to safety and potential use errors
  • Identify known/foreseeable hazards and hazardous situations
  • Describe hazard‑related use scenarios and select those for summative evaluation
  • Establish user‑interface specification and an evaluation plan (formative and summative)
  • Perform UI design, formative evaluations, then summative evaluations
  • Special handling for user interfaces of unknown provenance
• Documentation: Maintain a usability engineering file as evidence of the applied process and decisions.
• Annexes: Informative guidance, examples of hazardous situations, evaluation approaches, and mapping to essential principles.

Practical applications

• Design teams use IEC 62366-1 to integrate human factors engineering into medical device development, ensuring UI design reduces use‑error risks.
• Regulatory and quality professionals apply its process to compile evidence for regulatory submissions and post‑market risk assessments.
• Usability specialists and test labs use the standard to plan and execute formative (iterative) and summative (validation) usability testing and to select safety‑critical scenarios.
• Risk managers leverage the strengthened link to ISO 14971 to align usability controls with overall device risk management.
• Useful for all devices where user interaction can cause harm - from consumer‑facing diagnostics to clinical equipment.

Related standards

• ISO 14971 (risk management for medical devices) - closely referenced for hazard identification and risk control.
• IEC 62366-2 - tutorial and extended methods to help implement Part 1.

Keywords: IEC 62366-1, usability engineering, medical device usability, human factors, ISO 14971, risk management, user interface, formative evaluation, summative evaluation, usability engineering file.

Standards Content (Sample)

IEC 62366-1
Edition 1.0 2015-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
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IEC 62366-1
Edition 1.0 2015-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical devices –
Part 1: Application of usability engineering to medical devices

Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs

médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2281-2

– 2 – IEC 62366-1:2015  IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 * Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Principles . 12
4.1 General requirements . 12
4.1.1 * USABILITY ENGINEERING PROCESS . 12
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design . 13
4.1.3 Information for SAFETY as it relates to USABILITY . 13
4.2 * USABILITY ENGINEERING FILE . 14
4.3 Tailoring of the USABILITY ENGINEERING effort . 14
5 * USABILITY ENGINEERING PROCESS . 14
5.1 * Prepare USE SPECIFICATION . 14
5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS . 15
5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 15
5.4 * Identify and describe HAZARD-RELATED USE SCENARIOS . 15
5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 16
5.6 * Establish USER INTERFACE SPECIFICATION . 16
5.7 * Establish USER INTERFACE EVALUATION plan . 16
5.7.1 General . 16
5.7.2 * FORMATIVE EVALUATION planning . 17
5.7.3 * SUMMATIVE EVALUATION planning . 17
5.8 * Perform USER INTERFACE design, implementation and FORMATIVE
EVALUATION . 18
5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE . 19
5.10 USER INTERFACE OF UNKNOWN PROVENANCE . 19
Annex A (informative) General guidance and rationale . 20
A.1 General guidance . 20
A.2 Rationale for requirements in particular clauses and subclauses . 20
ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS related to
USABILITY . 38
Annex C (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 41
C.1 General . 41
C.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN
PROVENANCE . 41
C.2.1 * USE SPECIFICATION . 41
C.2.2 * Review of POST-PRODUCTION information . 42
C.2.3 HAZARDS and HAZARDOUS SITUATIONS related to USABILITY. 42
C.2.4 RISK CONTROL . 42
C.2.5 RESIDUAL RISK evaluation . 42
Annex D (informative) Types of MEDICAL DEVICE use, with examples . 43
Annex E (informative) Reference to the essential principles . 45
Bibliography . 46
Index of defined terms . 49

Figure 1 – Relationship of the types of use . 8
Figure A.1 – Model of USER-MEDICAL DEVICE interaction . 24
Figure A.2 – Relationship of TASKS and functions within a USE SCENARIO . 25
Figure A.3 – Relationship of TASKS and functions and USE ERROR within a HAZARD-
RELATED USE SCENARIO . 26
Figure A.4 – The relationship between the RISK MANAGEMENT PROCESS
(ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) . 32
Figure D.1 – Interrelationships between the different types of MEDICAL DEVICE use, with
examples . 44

Table B.1 – Glossary of relevant RISK MANAGEMENT terms . 38
Table B.2 – Examples of HARM due to RISK caused by USE ERROR(S) or poor USABILITY
(1 of 3) . 38
Table E.1 – Correspondence between this document and the essential principles . 45

– 4 – IEC 62366-1:2015  IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICES –
Part 1: 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
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International Standard IEC 62366-1 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
ISO technical committee 210: Quality management and corresponding general aspects for
MEDICAL DEVICES.
It is published as double logo standard.
This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and
replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014).
Part 1 has been updated to include contemporary concepts of USABILITY ENGINEERING, while
also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods
of RISK MANAGEMENT as applied to SAFETY related aspects of medical device user interfaces.
Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as
offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied

more generally to MEDICAL DEVICES that go beyond safety-related aspects of MEDICAL DEVICE
USER INTERFACES.
The text of this standard is based on the following documents:
FDIS Report on voting
62A/977/FDIS 62A/988/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 26 P-members
out of 26 having cast a vote.
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.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
Clauses and subclauses for which a rationale is provided in informative Annex A are marked
with an asterisk (*).
A list of all parts of the IEC 62366 series, published under the general title Medical devices,
can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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.
NOTE The attention of National Committees and Member Bodies is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of a new, amended or
revised IEC or ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this
publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of
publication.
– 6 – IEC 62366-1:2015  IEC 2015
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 (HUMAN FACTORS ENGINEERING) PROCESS are non-intuitive, difficult to
learn and difficult to use. As healthcare evolves, less skilled USERS including PATIENTS
themselves are now using MEDICAL DEVICES and MEDICAL DEVICES are becoming more
complicated. The design of the USER INTERFACE to achieve adequate USABILITY requires a
different PROCESS and skill set than that of the technical implementation of the USER
INTERFACE.
The USABILITY ENGINEERING PROCESS is intended to identify and minimise USE ERRORS and
thereby reduce use-associated RISKS. Some, but not all, forms of incorrect use are suited to
control by the MANUFACTURER. The USABILITY ENGINEERING PROCESS is related to the RISK
MANAGEMENT PROCESS as indicated in Figure A.4.
This International Standard describes a USABILITY ENGINEERING PROCESS to provide acceptable
RISK related to USABILITY of a MEDICAL DEVICE. 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.
This International Standard strictly focuses on applying the USABILITY ENGINEERING PROCESS to
optimize MEDICAL DEVICE USABILITY as it relates to SAFETY. The companion technical report
(IEC 62366-2 ) is comprehensive and has a broader focus. It focuses not only on USABILITY as
it relates to SAFETY, but also on how USABILITY relates to attributes such as TASK accuracy,
completeness and EFFICIENCY, and USER satisfaction.
NOTE SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead
to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.
MANUFACTURERS can choose to implement a USABILITY ENGINEERING program focused narrowly
on SAFETY or more broadly on SAFETY and other attributes, such as those cited above. A
broader focus might also be useful to address specific USABILITY ENGINEERING expectations,
such as the need to confirm that USERS can successfully perform non-SAFETY-related TASKS. A
MANUFACTURER might also implement a broader program to realize the commercial benefits of
a MEDICAL DEVICE that not only is safe to use but also offers superior USABILITY.
—————————
IEC 62366-2, Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
(in preparation).
MEDICAL DEVICES –
Part 1: Application of usability engineering to medical devices

1 * Scope
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop
and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY
ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess
and mitigate RISKS 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 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead
to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.
NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-2 ,
which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY.
If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been
complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be
acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography beginning on page 46.
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 49.
3.1
* ABNORMAL USE
conscious, intentional act or intentional omission of an act that is counter to or violates
NORMAL USE and is also beyond any further reasonable means of USER INTERFACE-related RISK
CONTROL by the MANUFACTURER
EXAMPLES Reckless use or sabotage or intentional disregard of information for SAFETY are such acts.
—————————
IEC 62366-2, Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
(in preparation).
– 8 – IEC 62366-1:2015  IEC 2015
Note 1 to entry See also 4.1.3.
Note 2 to entry: An intended but erroneous action that is not ABNORMAL USE is considered a type of USE ERROR.
Note 3 to entry: ABNORMAL USE does not relieve the MANUFACTURER from considering non-USER INTERFACE-related
means of RISK CONTROL.
Note 4 to entry: Figure 1 shows the relationships of the types of use.
IEC
NOTE Figure D.1 contains additional detail
Figure 1 – Relationship of the types of use
3.2
ACCOMPANYING DOCUMENTATION
materials accompanying a MEDICAL DEVICE and containing information for the USER or those
accountable for the installation, use and maintenance of the MEDICAL DEVICE, particularly
regarding safe use
Note 1 to entry: The ACCOMPANYING DOCUMENTATION can consist of the instructions for use, technical description,
installation manual, quick reference guide, etc.
Note 2 to entry: ACCOMPANYING DOCUMENTATION is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types.
Note 3 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having
instructions for use by some authorities with jurisdiction.
[SOURCE: ISO 14971:2007, 2.1, modified – The term has been changed to refer to
‘documentation’ rather than ‘document’, and in the definition ‘document’ has been replaced by
‘material’, ‘OPERATOR’ has been deleted and notes to entry have been added.]
3.3
CORRECT USE
NORMAL USE without USE ERROR
Note 1 to entry: Deviation from instructions for use is only considered USE ERROR if it leads to a MEDICAL DEVICE
response that is different than intended by the MANUFACTURER or expected by the USER.
Note 2 to entry: Figure 1 shows the relationships of the types of use.
3.4
EFFECTIVENESS
accuracy and completeness with which USERS achieve specified goals
Note 1 to entry: This is a different concept than 'clinical effectiveness'.
[SOURCE: ISO 9241-11:1998, 3.2, modified – Added the note to entry.]

3.5
* EFFICIENCY
resources expended in relation to EFFECTIVENESS
[SOURCE: ISO 9241-11:1988, 3.3, modified – the term "EFFECTIVENESS" has replaced the
original phrase, which here constitutes the definition of 3.4 EFFECTIVENESS.
3.6
EXPECTED SERVICE LIFE
time period specified by the MANUFACTURER during which the MEDICAL DEVICE is expected to
remain safe for use (i.e. maintain basic SAFETY and essential performance)
Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE.
[SOURCE: IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.28, modified – In the
definition, ‘ME EQUIPMENT and ME SYSTEM’ have been replaced with ‘MEDICAL DEVICE’.]
3.7
FORMATIVE EVALUATION
USER INTERFACE EVALUATION conducted with the intent to explore USER INTERFACE design
strengths, weaknesses, and unanticipated USE ERRORS
Note 1 to entry: FORMATIVE EVALUATION is generally performed iteratively throughout the design and development
PROCESS, but prior to SUMMATIVE EVALUATION, to guide USER INTERFACE design as necessary.
3.8
HAZARD-RELATED USE SCENARIO
USE SCENARIO that could lead to a HAZARDOUS SITUATION or HARM
Note 1 to entry: A HAZARD-RELATED USE SCENARIO can often be linked to a potential USE ERROR.
Note 2 to entry: A HAZARD-RELATED USE SCENARIO is not related to a failure of the MEDICAL DEVICE, unless the
MEDICAL DEVICE failure was caused by a USE ERROR.
3.9
* NORMAL USE
operation, including routine inspection and adjustments by any USER, and stand-by, according
MEDICAL
to the instructions for use or in accordance with generally accepted practice for those
DEVICES provided without instructions for use
Note 1 to entry: NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as
intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not
only the medical purpose, but maintenance, transport, etc. as well.
Note 2 to entry: USE ERROR can occur in NORMAL USE.
EDICAL DEVICES that can be used safely without instructions for use are exempted from having
Note 3 to entry: M
instructions for use by some authorities with jurisdiction.
Note 4 to entry: Figure 1 shows the relationships of the types of use.
[SOURCE: IEC 60601-1:2005, 3.71, modified – Notes 2, 3 and 4 to entry have been added,
and in the definition ‘OPERATOR’ has been replaced with ‘USER’ and the entire phrase after
"instructions for use" has been added.]
3.10
* PATIENT
living being (person) undergoing a medical, surgical or dental PROCEDURE
Note 1 to entry: A PATIENT can be a USER.

– 10 – IEC 62366-1:2015  IEC 2015
[SOURCE: IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.76, modified – The
phrase ‘or animal’ has been deleted from the definition and "USER" has been substituted for
"operator" in the note to entry.]
3.11
* PRIMARY OPERATING FUNCTION
USER interaction that is related to the SAFETY of the MEDICAL DEVICE
function that involves
Note 1 to entry: Often a PRIMARY OPERATING FUNCTION is interacted with by a series of TASKS that can be broken
down into a series of USER interactions.
Note 2 to entry: The concept of SAFETY includes loss or degradation of performance resulting in an unacceptable
RISK to the PATIENT, including USE ERROR that prevents the USER from effectively using the MEDICAL DEVICE to
achieve its intended medical purpose. In IEC 60601-1, this is referred to as ‘essential performance’. .
3.12
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL DEVICE or combination of MEDICAL
DEVICES
Note 1 to entry: 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 to entry: Education and training are included in "use."
[SOURCE: IEC 60601-1:2005, 3.101, modified – The reference in the definition to ‘an
ME EQUIPMENT or ME SYSTEM’ has been replaced with ‘a MEDICAL DEVICE OR COMBINATION OF
MEDICAL DEVICES’ and 'operator' has been replaced by 'USER' in the note to entry.]
3.13
SUMMATIVE EVALUATION
USER INTERFACE EVALUATION conducted at the end of the USER INTERFACE development with the
intent to obtain OBJECTIVE EVIDENCE that the USER INTERFACE can be used safely
Note 1 to entry: SUMMATIVE EVALUATION relates to validating the safe use of the USER INTERFACE.
3.14
TASK
one or more USER interactions with a MEDICAL DEVICE to achieve a desired result
Note 1 to entry: A TASK description should include the allocation of activities and operational steps between the
USER and the MEDICAL DEVICE.
Note 2 to entry: TASKS should not be described solely in terms of the functions or features provided by the
MEDICAL DEVICE.
3.15
UOUP
USER INTERFACE OF UNKNOWN PROVENANCE
USER INTERFACE or part of a USER INTERFACE of a MEDICAL DEVICE previously developed for
which adequate RECORDS of the USABILITY ENGINEERING PROCESS of this standard are not
available
Note 1 to entry: This note applies to the French version only.
3.16
* USABILITY
characteristic of the USER INTERFACE that facilitates use and thereby establishes
EFFECTIVENESS, EFFICIENCY and USER satisfaction in the intended USE ENVIRONMENT
Note 1 to entry: All aspects of USABILITY, including EFFECTIVENESS, EFFICIENCY and USER satisfaction, can either
increase or decrease SAFETY.
3.17
* USABILITY ENGINEERING
HUMAN FACTORS ENGINEERING
application of knowledge about human behaviour, abilities, limitations, and other
characteristics to the design of MEDICAL DEVICES (including software), systems and TASKS to
USABILITY
achieve adequate
Note 1 to entry: Achieving adequate USABILITY can result in acceptable RISK related to use.
3.18
USABILITY ENGINEERING FILE
*
set of RECORDS and other documents that are produced by the USABILITY ENGINEERING
PROCESS
3.19
USABILITY TEST
method for exploring or evaluating a USER INTERFACE with intended USERS within a specified
intended USE ENVIRONMENT
3.20
USE ENVIRONMENT
actual conditions and setting in which USERS interact with the MEDICAL DEVICE
Note 1 to entry: The conditions of use or attributes of the USE ENVIRONMENT can include hygienic requirements,
frequency of use, location, lighting, noise, temperature, mobility, and degree of internationalization.
3.21
* USE ERROR
USER action or lack of USER action while using the MEDICAL DEVICE that leads to a different
result than that intended by the MANUFACTURER or expected by the USER
Note 1 to entry: USE ERROR includes the inability of the USER to complete a TASK.
Note 2 to entry: USE ERRORS can result from a mismatch between the characteristics of the USER, USER
INTERFACE, TASK, or USE ENVIRONMENT.
Note 3 to entry: USERS might be aware or unaware that a USE ERROR has occurred.
Note 4 to entry: An unexpected physiological response of the PATIENT is not by itself considered USE ERROR.
Note 5 to entry: A malfunction of a MEDICAL DEVICE that causes an unexpected result is not considered a USE
ERROR.
Note 6 to entry: Figure 1 shows the relationships of the types of use.
3.22
* USE SCENARIO
specific sequence of TASKS performed by a specific USER in a specific USE ENVIRONMENT and
any resulting response of the MEDICAL DEVICE
3.23
* USE SPECIFICATION
APPLICATION SPECIFICATION
summary of the important characteristics related to the context of use of the MEDICAL DEVICE
Note 1 to entry: The intended medical indication, PATIENT population, part of the body or type of tissue interacted
with, USER PROFILE, USE ENVIRONMENT, and operating principle are typical elements of the USE SPECIFICATION.
Note 2 to entry: The summary of the MEDICAL DEVICE USE SPECIFICATION is referred to by some authorities having
jurisdiction as the ‘statement of intended use’.
Note 3 to entry: The USE SPECIFICATION is an input to determining the INTENDED USE of ISO 14971:2007.

– 12 – IEC 62366-1:2015  IEC 2015
3.24
* USER
person interacting with (i.e. operating or handling) the MEDICAL DEVICE
Note 1 to entry: There can be more than one USER of a MEDICAL DEVICE.
Note 2 to entry: Common USERS include clinicians, PATIENTS, cleaners, maintenance and service personnel.
3.25
USER GROUP
subset of intended USERS who are differentiated from other intended USERS by factors that are
likely to influence USABILITY, such as age, culture, expertise or type of interaction with a
MEDICAL DEVICE
3.26
* USER INTERFACE
means by which the USER and the MEDICAL DEVICE interact
Note 1 to entry: ACCOMPANYING DOCUMENTATION is considered part of the MEDICAL DEVICE AND ITS USER INTERFACE.
Note 2 to entry: USER INTERFACE includes all the elements of the MEDICAL DEVICE with which the USER interacts
including the physical aspects of the MEDICAL DEVICE as well as visual, auditory, tactile displays and is not limited
to a software interface.
Note 3 to entry: For the purposes of this standard, a system of MEDICAL DEVICES can be treated as a single USER
INTERFACE.
3.27
USER INTERFACE EVALUATION
PROCESS by which the MANUFACTURER explores or assesses the USER interactions with the
USER INTERFACE
Note 1 to entry: A USER INTERFACE EVALUATION may consist of one or more of the following techniques, amongst
others, USABILITY TESTS, expert reviews, heuristic analyses, design audits or a cognitive walk through.
Note 2 to entry: USER INTERFACE EVALUATION is frequently performed iteratively throughout the design and
development PROCESS (this is FORMATIVE EVALUATION).
Note 3 to entry: USER INTERFACE EVALUATION is a part of the activities involved in verifying and validating the
overall MEDICAL DEVICE design (this is SUMMATIVE EVALUATION).
3.28
* USER INTERFACE SPECIFICATION
collection of specifications that comprehensively and prospectively describe the USER
INTERFACE of a MEDICAL DEVICE
3.29
USER PROFILE
summary of the mental, physical and demographic traits of an intended USER GROUP, as well
as any special characteristics, such as occupational skills, job requirements and working
conditions, which can have a bearing on design decisions
4 Principles
4.1 General requirements
4.1.1 * USABILITY ENGINEERING PROCESS
The MANUFACTURER shall establish, document, implement and maintain a USABILITY
ENGINEERING PROCESS, as defined in Clause 5, to provide SAFETY for the PATIENT, USER and
others. The PROCESS shall address USER interactions with the MEDICAL DEVICE according to the
ACCOMPANYING DOCUMENTATION, including, but not limited to:

– * transport;
– * storage;
– installation;
– operation;
– maintenance and repair; and
– disposal.
USABILITY ENGINEERING activities for a MEDICAL DEVICE shall be planned, carried out, and
documented by personnel competent on the basis of appropriate education, training, skills or
experience.
Where a documented product realization PROCESS exists, such as that described in Clause 7
of ISO 13485:2003 [11], it shall incorporate the appropriate parts of or reference the USABILITY
ENGINEERING PROCESS.
NOTE 1 Subclause 6.2 of ISO 13485:2003 contains additional information relating to personnel competence.
A depiction of the interrelationship between the RISK MANAGEMENT PROCESS of ISO 14971:2007
and the USABILITY ENGINEERING PROCESS described in this standard is shown in Figure A.4.
The activities described in Clause 5, as shown Figure A.4, are described in a logical order,
but they may be carried out in a flexible order as appropriate.
Consider compliance with this subclause to exist when the requirements of this International
Standard have been fulfilled.
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design
To reduce use-related RISK, the MANUFACTURER shall use one or more of the following options,
in the priority listed (as required by ISO 14971:2007, 6.2):
SAFETY by design;
a) inherent
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS;
SAFETY.
c) information for
NOTE Information for SAFETY can also be required by product standards and other sources.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
4.1.3 Information for SAFETY as it relates to USABILITY
When, in accordance with the priorities of 4.1.2, information for SAFETY is used as a RISK
CONTROL measure, the MANUFACTURER shall subject this information to the USABILITY
ENGINEERING PROCESS to determine that the information
– is perceivable by,
– is understandable to, and
– supports CORRECT USE of the MEDICAL DEVICE by
USERS of the intended USER PROFILES in the context of the intended USE ENVIRONMENT.
NOTE 1 The relationship between USER perception, cognition and action is shown in Figure A.1.
NOTE 2 Examples of information for SAFETY are found in IEC 62366-2.
Conscious disregard of such information for SAFETY by the USER is considered to be an
intentional act or intentional omission of an act that is counter to or violates NORMAL USE and

– 14 – IEC 62366-1:2015  IEC 2015
is also beyond any further reasonable means of USER INTERFACE-related RISK CONTROL by the
MANUFACTURER (i.e. ABNORMAL USE).
Compliance is checked by inspection of the information for SAFETY and the USABILITY
ENGINEERING FILE.
4.2 * USABILITY ENGINEERING FILE
The results of the USABILITY ENGINEERING PROCESS shall be stored 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 Tailoring of the USABILITY ENGINEERING effort
The level of effort and the choice of methods and tools used to perform the USABILITY
ENGINEERING PROCESS may vary based on:
a) the size and COMPLEXITY of the USER INTERFACE;
b) the SEVERITY of the HARM associated with the use of the MEDICAL DEVICE;
c) the extent or complexity of the USE SPECIFICATION;
d) the presence of USER INTERFACE OF UNKNOWN PROVENANCE; and
e) the extent of the modification to an existing MEDICAL DEVICE USER INTERFACE that had been
subjected to the USABILITY ENGINEERING PROCESS.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5 * USABILITY ENGINEERING PROCESS
5.1 * Prepare USE SPECIFICATION
The MANUFACTURER shall prepare a USE SPECIFICATION.
The USE SPECIFICATION shall include:
– * intended medical indication;
NOTE 1 This can include conditions(s) or disease(s) to be screened, monitored, treated, diagnosed, or
prevented.
– intended PATIENT population;
NOTE 2 This can include age group, weight range, health, or condition.
– intended part of the body or type of tissue applied to or interacted with;
– * intended USER PROFILE;
– * USE ENVIRONMENT; and
– * operating principle.
NOTE 3 The summary of the MEDICAL DEVICE USE SPECIFICATION is referred to by some authorities having
jurisdiction as the ‘statement of intended use’.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS
The MANUFACTURER shall identify USER INTERFACE characteristics that could be related to
SAFETY as part of a RISK ANALYSIS performed according to ISO 14971:2007, 4.2. This
identification may also be performed using the tools and techniques from the USABILITY
ENGINEERING PROCESS. This identification shall include consideration of the PRIMARY
OPERATING FUNCTIONS that are provided in applicable particular MEDICAL DEVICE SAFETY
standards.
NOTE 1 ISO 14971:2007, C.2.29 to C.2.34 provides a list of questions that can be used to identify USER
INTERFACE characteristics that could impact SAFETY. The list of questions is not exhaustive.
Based on the identified USER INTERFACE characteristics and USE SPECIFICATION, the
MANUFACTURER shall identify the USE ERRORS that could occur and are related to the USER
INTERFACE. This identification may be accomplished by conducting a TASK analysis.
[27][28][29]
NOTE 2 TASK analysis is descri
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