EN 60601-1-6:2007

SLOVENSKI STANDARD
01-januar-2008
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Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral Standard: Usability (IEC 60601-1-6:2006)
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm:
Gebrauchstauglichkeit (IEC 60601-1-6:2006)
Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Aptitude a l'utilisation (IEC 60601-1-
6:2006)
Ta slovenski standard je istoveten z: EN 60601-1-6:2007
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-6
NORME EUROPÉENNE
July 2007
EUROPÄISCHE NORM
ICS 11.040 Supersedes EN 60601-1-6:2004

English version
Medical electrical equipment -
Part 1-6: General requirements
for basic safety and essential performance -
Collateral Standard: Usability
(IEC 60601-1-6:2006)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-6: Exigences générales Teil 1-6: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Aptitude à l'utilisation Ergänzungsnorm: Gebrauchstauglichkeit
(CEI 60601-1-6:2006) (IEC 60601-1-6:2006)

This European Standard was approved by CENELEC on 2007-05-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-6:2007 E
Foreword
The text of document 62A/550/FDIS, future edition 2 of IEC 60601-1-6, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 60601-1-6 on 2007-05-01.
The following date was fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-02-01
This European Standard supersedes EN 60601-1-6:2004. However, EN 60601-1-6:2004 remains valid
until all the parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of
conflicting national standards (dow) has therefore been fixed. However, when Part 1-6 is used for
appliances not covered by a part 2, EN 60601-1-6:2004 is not to be used after 2009-09-12.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
This EN 60601-1-6 was revised to structurally align it with EN 60601-1:2006 and to implement the
decision of IEC SC 62A that the clause numbering structure of collateral standards written to
EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle
technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk
management process in EN 60601-1:2006.
In the 60601 series of publications, collateral standards specify general requirements for safety
applicable to
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general
standard (e.g. alarm systems).
In this collateral standard the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in 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 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTES:
IN SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the six numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses
of Clause 6).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this standard are by number only.

- 3 - EN 60601-1-6:2007
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, subclauses and definitions for which a rationale is provided in informative Annex A are
marked with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-6:2006 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
NOTE   Harmonized as EN ISO 9000:2000 (not modified).
ISO 9000
ISO 9001 NOTE   Harmonized as EN ISO 9001:2000 (not modified).
ISO 9241-11 NOTE   Harmonized as EN ISO 9241-11:1998 (not modified).
ISO 13485 NOTE   Harmonized as EN ISO 13485:2003 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
safety and essential performance

IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
safety and essential performance -
Collateral Standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
ISO/IEC 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices + corr. February 2002

- 5 - EN 60601-1-6:2007
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling
within the scope of this standard.
___________
IEC 60601-1-6
Edition 2.0 2006-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability

Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l’utilisation

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040 ISBN 2-8318-8933-2
60601-1-6 © IEC:2006 –– 2 – 3 – 60601-1-6 © IEC:2006
CONTENTS
FOREWORD.3
INTRODUCTION.6

1 Scope, object and related standards.7
1.1 Scope.7
1.2 Object .7
1.3 Related standards .7
2 Normative references .7
3 Terms and definitions .8
4 General requirements .10
4.1 * Conditions for application to ME EQUIPMENT .10
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT.10
5 ME EQUIPMENT identification, marking and documents.10
5.1 * ACCOMPANYING DOCUMENTS.10
5.2 * TRAINING and materials for TRAINING .11
6 * USE ERROR and USABILITY .11
6.1 * Safety for the PATIENT, OPERATOR and other persons .11
6.2 * USABILITY ENGINEERING PROCESS .11

Annex A (informative) General guidance and rationale.15
Annex B (informative) A taxonomy of OPERATOR action .21
Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and design flaws
potentially leading to USE ERRORS .22
Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS.25
Annex E (informative) Sample USABILITY SPECIFICATION .53
Annex F (informative) Reference documents.62

Bibliography.71

Index of defined terms used in this collateral standard.73

Figure B.1 – Summary of the taxonomy of OPERATOR action.21
Figure D.1 – An OPERATOR-EQUIPMENT INTERFACE design cycle.28
Figure D.2 – Bubble diagram of the conceptual model of a physiological monitor.43
Figure E.1 – Example of a USABILITY SPECIFICATION for a hypothetical device .53

Table D.1 – Sample of design flaws and associated USE ERRORS .27
Table D.2 – Mapping of Figure D.1 to the subclauses of this standard .28
Table D.3 – Examples of OPERATOR-EQUIPMENT INTERFACE requirements .31
Table D.4 – Typical deliverables .37
Table D.5 – Examples of objective and subjective USABILITY goals .41
Table D.6 – Examples of OPERATOR-EQUIPMENT INTERFACE modelling techniques .44
Table D.7 – Characteristics of a typical USABILITY testing effort .44

60601-1-6 © IEC:200660601-1-6 © IEC:2006 –– 3 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-6: General requirements for basic safety
and essential performance –
Collateral Standard: Usability

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
misinterpretation by any end user.
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
equipment 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 60601-1-6 has been prepared by IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice of IEC technical committee 62:
Electrical equipment in medical practice.
This second edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for safety and essential performance hereafter
referred to as the general standard.
This document cancels and replaces the first edition of IEC 60601-1-6.

60601-1-6 © IEC:2006 –– 4 – 7 – 60601-1-6 © IEC:2006
This edition of IEC 60601-1-6 was revised to structurally align it with the 2005 edition of IEC
60601-1 and to implement the decision of IEC Subcommittee 62A that the clause numbering
structure of collateral standards written to IEC 60601-1:2005 would adhere to the form
specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4,
which now recognizes that there is a general requirement for a risk management process in
IEC 60601-1:2005.
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/550/FDIS 62A/557/RVD
Full information on the voting for the approval of this collateral standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the IEC 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. alarm systems).
In this collateral standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: 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 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 6 includes subclauses 6.1, 6.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all
subclauses of Clause 6).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this standard are by number only.
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;

60601-1-6 © IEC:200660601-1-6 © IEC:2006 –– 5 – 9 –
− “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).
A list of all parts of the IEC 60601 series, under the general title: Medical electrical
equipment, can be found on the IEC website.
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.
60601-1-6 © IEC:2006 –– 6 – 11 – 60601-1-6 © IEC:2006
INTRODUCTION
Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT for observation and
treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL ELECTRICAL EQUIPMENT
USABILITY have become an increasing cause for concern. 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 an element of the
RISK MANAGEMENT PROCESS.
This collateral standard describes a USABILITY ENGINEERING PROCESS, and provides guidance
on how to implement and execute the PROCESS to provide BASIC SAFETY and ESSENTIAL
PERFORMANCE as it relates to USABILITY of MEDICAL ELECTRICAL EQUIPMENT. It is intended to be
useful not only for MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT, but also for technical
committees responsible for the preparation of particular standards.

60601-1-6 © IEC:200660601-1-6 © IEC:2006 –– 7 – 13 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-6: General requirements for basic safety
and essential performance –
Collateral Standard: Usability

1 Scope, object and related standards
1.1 Scope
This International Standard specifies requirements for a PROCESS to analyse, design, verify
and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This collateral
standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.
1.2 Object
The object of this collateral standard is to specify general requirements that are in addition to
those of the general standard and to serve as the basis for particular standards.
1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT, this collateral standard complements IEC 60601-1.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
• "the general standard" designates IEC 60601-1 alone;
• "this collateral standard" designates IEC 60601-1-6 alone;
• "this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
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.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems

60601-1-6 © IEC:2006 –– 8 – 15 – 60601-1-6 © IEC:2006
ISO 14971:2000, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1-8:2006 and the following definitions apply.
NOTE An index of defined terms is found beginning on page 145.
3.1
ABNORMAL USE
intended act or intended omission of an act by the RESPONSIBLE ORGANIZATION or OPERATOR of
ME EQUIPMENT as a result of conduct that is beyond any reasonable means of RISK CONTROL by
the MANUFACTURER
NOTE 1 See also Annex B. Examples are given in Annex C.
NOTE 2 It is possible for the PATIENT to be the OPERATOR, e.g. when ME EQUIPMENT is used in the PATIENT’S home.
NOTE 3 ABNORMAL USE is not considered REASONABLY FORESEABLE MISUSE.
3.2
EFFECTIVENESS
accuracy and completeness with which OPERATORS achieve specified goals
[ISO 9241-11:1998, definition 3.2, modified]
3.3
EFFICIENCY
resources expended in relation to the accuracy and completeness with which OPERATORS
achieve goals
[ISO 9241-11:1998, definition 3.3 modified]
3.4
OPERATOR-EQUIPMENT INTERFACE
*
means by which the OPERATOR and the ME EQUIPMENT communicate
[ANSI/AAMI/HE 74:2001, definition 3.24 modified]
NOTE The ACCOMPANYING DOCUMENTS are considered part of the ME EQUIPMENT and the OPERATOR-EQUIPMENT
INTERFACE.
3.5
OPERATOR PROFILE
summary of the mental, physical and demographic traits of the intended OPERATOR population,
as well as any special characteristics that can have a bearing on design decisions, such as
occupational skills and job requirements
3.6
* PRIMARY OPERATING FUNCTION
function that involves OPERATOR interaction that is either frequently used or related to the
BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME EQUIPMENT in NORMAL USE
3.7
* REASONABLY FORESEEABLE MISUSE
use by the OPERATOR in a way not intended by the MANUFACTURER but which can result from
readily predictable human behaviour
[ISO/IEC Guide 51:1999, definition 3.14, modified]

60601-1-6 © IEC:200660601-1-6 © IEC:2006 –– 9 – 17 –
NOTE 1 REASONABLY FORESEEABLE MISUSE is an intended action.
NOTE 2 Use refers to a product, PROCESS or service.
NOTE 3 Slips, lapses, mistakes and ABNORMAL USE can also be reasonably foreseeable, but are not considered
REASONABLY FORESEEABLE MISUSE.
NOTE 4 See also Annex B.
3.8
TRAINING
application-specific OPERATOR-oriented instruction or exercises required for the safe and
effective use of the ME EQUIPMENT
3.9
USE ERROR
act or omission of an act that has a different ME EQUIPMENT response than intended by the
MANUFACTURER or expected by the OPERATOR
NOTE 1 USE ERROR includes slips, lapses, mistakes, and REASONABLY FORESEEABLE MISUSE.
NOTE 2 See also Annex B and D.1.3.
NOTE 3 The physiological response of the PATIENT is not considered part of USE ERROR.
3.10
USE SCENARIO
sequence of events and tasks used to specify and test the USABILITY of the ME EQUIPMENT
3.11
* USABILITY
characteristic that establishes EFFECTIVENESS, EFFICIENCY and OPERATOR learnability and
satisfaction
3.12
USABILITY ENGINEERING
application of knowledge about human behaviour, abilities, limitations, and other
characteristics to the design of tools, machines, ME EQUIPMENT, devices, systems, tasks, jobs,
and environments to achieve adequate USABILITY
3.13
* USABILITY ENGINEERING FILE
set of RECORDS and other documents that are produced by USABILITY ENGINEERING activities
3.14
USABILITY SPECIFICATION
documentation defining the OPERATOR-EQUIPMENT INTERFACE requirements related to USABILITY
3.15
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]

60601-1-6 © IEC:2006 –– 10 – 19 – 60601-1-6 © IEC:2006
4 General requirements
4.1 * Conditions for application to ME EQUIPMENT
The ME EQUIPMENT shall provide adequate USABILITY such that the RISKS resulting from NORMAL
and USE ERROR are acceptable. See also 7.1.1 and 12.2 of the general standard.
USE
Compliance with this subclause is considered to exist when compliance with the other clauses
and subclauses of this collateral standard is demonstrated.
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT
When performing the RISK ANALYSIS step of the RISK MANAGEMENT PROCESS required by 4.2 of
the general standard, the analysis shall consider the following:
– application specification (see 6.2.2.1);
– OPERATOR PROFILE;
– predictable USE ERRORS (see ANNEX C for a list of predictable USE ERRORS);
– * task related requirements;
– * context of use;
– information on HAZARDS known for existing OPERATOR-EQUIPMENT INTERFACES for
ME EQUIPMENT of a similar type, if available;
– results of the review of the OPERATOR-EQUIPMENT INTERFACE (see D.2.2 in this document
and D.7 of ISO 14971:2000).
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
5 ME EQUIPMENT identification, marking and documents
5.1 * ACCOMPANYING DOCUMENTS
A brief description of the ME EQUIPMENT, its physical operating principles and significant
physical and performance characteristics relevant to its USABILITY, shall be included in the
instructions for use. The same information shall also be included in the technical description,
if this is provided as a separate document.
ACCOMPANYING DOCUMENTS for ME EQUIPMENT may be provided electronically, e.g. by
electronic file format or CD-ROM. If the ACCOMPANYING DOCUMENTS are provided
electronically, the USABILITY ENGINEERING PROCESS shall include consideration of which
information also needs to be provided as hard copy or as markings on the ME EQUIPMENT, e.g.
to cover emergency operation.
The ACCOMPANYING DOCUMENTS shall include a description of the OPERATOR PROFILE. The
ACCOMPANYING DOCUMENTS shall be written at a level consistent with the intended OPERATOR
PROFILE.
Compliance is checked by inspecting the ACCOMPANYING DOCUMENTS and the USABILITY
ENGINEERING FILE.
60601-1-6 © IEC:200660601-1-6 © IEC:2006 –– 11 – 21 –
5.2 * TRAINING and materials for TRAINING
If ME EQUIPMENT specific TRAINING is required for the PRIMARY OPERATING FUNCTIONS of the
ME EQUIPMENT, the MANUFACTURER shall:
– provide the necessary materials for TRAINING;
– ensure that these materials are available; or
– provide the TRAINING.
NOTE 1 ME EQUIPMENT-specific TRAINING provides the knowledge and skills required for safe and effective use of
ME EQUIPMENT in addition to the OPERATOR PROFILE.
The INTENDED USE shall be the basis for TRAINING and TRAINING material. The instructions for
use shall indicate whether specific TRAINING for this ME EQUIPMENT is required and shall
indicate the available TRAINING options.
1)
NOTE 2 See IEC 61258 [1].
6 * USE ERROR and USABILITY
6.1 * Safety for the PATIENT, OPERATOR and other persons
A USABILITY ENGINEERING PROCESS shall be conducted to provide safety for the PATIENT,
OPERATOR and other persons related to USABILITY of the OPERATOR-EQUIPMENT INTERFACE.
NOTE 1 To guide the application of USABILITY ENGINEERING principles, the HAZARDS to PATIENTS, OPERATORS and
other persons as listed in ISO 14971 should be considered.
NOTE 2 The following are examples of HAZARDS for the PATIENT:
– unintentional setting of the diagnostic or therapeutic ME EQUIPMENT, e.g. inappropriate X-ray exposure setting
requiring an additional exposure;
– unintentional interruption of delivery of therapy;
– misinterpretation of displayed values followed by an inappropriate treatment;
– confusing data presentation contributing to mental fatigue resulting in increased USE ERROR.
NOTE 3 The following are examples of HAZARDS for the OPERATOR:
– poor anthropometric design leading to musculoskeletal injury;
– repetitive-motion resulting in nerve/tendon injuries;
– poor display contrast resulting in eye fatigue;
– loud noise emanating from the ME EQUIPMENT resulting in hearing impairment.
Compliance with this subclause is considered to exist when compliance with the other clauses
and subclauses of this collateral standard is demonstrated.
6.2 * USABILITY ENGINEERING PROCESS
6.2.1 General
The results of the USABILITY ENGINEERING PROCESS shall be recorded in the USABILITY
ENGINEERING FILE. The USABILITY ENGINEERING PROCESS may vary in form and extent based on
the nature of the ME EQUIPMENT, its intended OPERATOR and its INTENDED USE (see D.3.2). The
records and other documents that make up the USABILITY ENGINEERING FILE may form part of
other documents and files, e.g. a MANUFACTURER’S product file or RISK MANAGEMENT FILE.
—————————
1)
Figures in square brackets refer to the Bibliography.

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In the case of the modification of existing ME EQUIPMENT design, the USABILITY ENGINEERING
PROCESS may be scaled based on the significance of the modification depending on the
results of the RISK ANALYSIS (see D.3.2.2).
NOTE 1 The MANUFACTURER should conduct iterative design and development. USABILITY ENGINEERING should
begin early and continue through the ME EQUIPMENT design and development life cycle.
NOTE 2 Due to the iterative nature of the USABILITY ENGINEERING PROCESS, the activities described in the following
subclauses may be carried out in any convenient order (see D.2).
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
USABILITY ENGINEERING PROCESS
6.2.2 Input for the
6.2.2.1 * ME EQUIPMENT application specification
The MANUFACTURER shall specify the application of the ME EQUIPMENT in the USABILITY
ENGINEERING FILE.
This specification shall include:
– medical purpose (e.g. conditions(s) or disease(s) to be screened, monitored, treated, or
diagnosed);
– PATIENT population (e.g. age, weight, region of body, health, condition);
– part of the body or type of tissue applied to or interacted with;
– * intended OPERATOR PROFILE; and
– application (e.g. environment, frequency of use, location, mobility).
NOTE This specification contains elements of the INTENDED USE.
A summary of the ME EQUIPMENT application specification shall be included in the instructions
for use.
Compliance is checked by inspecting the USABILITY ENGINEERING FILE and the instructions for
use.
6.2.2.2 PRIMARY OPERATING FUNCTIONS
The MANUFACTURER shall determine the PRIMARY OPERATING FUNCTIONS and record them in the
USABILITY ENGINEERING FILE.
NOTE 1 See also D.5.3, D.5.5, D.5.9, D.5.10 and D.5.14 for a discussion of methods that might be useful in
determining PRIMARY OPERATING FUNCTIONS.
NOTE 2 PRIMARY OPERATING FUNCTIONS should be easily recognizable and self-explanatory to the OPERATOR.
NOTE 3 See element 1.2 of Figure E.1 for an example of PRIMARY OPERATING FUNCTIONS for a hypothetical
ME EQUIPMENT.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
6.2.2.3 * Information for safety as a RISK CONTROL
For RISK CONTROL related to USABILITY, the MANUFACTURER shall decide what information is
required for BASIC SAFETY or ESSENTIAL PERFORMANCE, e.g. warnings or limitation of use in the
ACCOMPANYING DOCUMENTS, marking, etc. Any such information shall be subject to the
USABILITY ENGINEERING PROCESS. Disregarding this information shall be considered ABNORMAL
USE. See also Annex B.
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NOTE 1 RISK CONTROL consists of an integrated approach in which the MANUFACTURER uses one or more of the
following in the priority listed:
a) inherent SAFETY by design;
b) protective measures in the ME EQUIPMENT 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.
The results of the RISK ANALYSIS or a reference to the location of the results of the RISK
ANALYSIS shall be recorded in the USABILITY ENGINEERING FILE.
NOTE 2 The RISK ANALYSIS for the ME EQUIPMENT or for the corresponding generic device type is an input for the
USABILITY SPECIFICATION as required for the USABILITY ENGINEERING PROCESS. Any RESIDUAL RISK evaluation should
consider the results of the USABILITY VALIDATION.
NOTE 3 The evaluation of post-production information (post-market surveillance) should include USABILITY (see
ISO 14971:2000, Clause 9).
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
6.2.3 * USABILITY SPECIFICATION
As part of the USABILITY ENGINEERING PROCESS, the MANUFACTURER shall develop a USABILITY
SPECIFICATION. The USABILITY SPECIFICATION shall be recorded in USABILITY ENGINEERING FILE.
The USABILITY SPECIFICATION may be integrated into other specifications.
The USABILITY SPECIFICATION shall be based on the following:
– application specification (see 6.2.2.1);
– HAZARDS related to the use of the ME EQUIPMENT (results from RISK ANALYSIS as described
in 4.2); and
– predictable USE ERRORS associated with the ME EQUIPMENT.
The USABILITY SPECIFICATION shall describe at least:
– * USE SCENARIOS for the ME EQUIPMENT;
– OPERATOR actions related to the PRIMARY OPERATING FUNCTIONS;
– OPERATOR-EQUIPMENT INTERFACE requirements for the PRIMARY OPERATING FUNCTIONS; and
– requirements for determining whether PRIMARY OPERATING FUNCTIONS are easily
recognizable by the OPERATOR.
NOTE 1 The USABILITY SPECIFICATION should include references to context of use (see the rationale for Subclause
4.2 and D.4.1.2.4).
NOTE 2 For guidance, see D.2.6.
NOTE 3 See Annex E for an example of a USABILITY SPECIFICATION for hypothetical ME EQUIPMENT.
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
6.2.4 * USABILITY VERIFICATION
As part of the ME EQUIPMENT design VERIFICATION PROCESS, the MANUFACTURER shall verify the
OPERATOR-EQUIPMENT interface design according to the USABILITY SPECIFICATION. The results of
the VERIFICATION shall be recorded in USABILITY ENGINEERING FILE.
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.

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6.2.5 Usability validation plan
The MANUFACTURER shall develop 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 (see Table D.5); and
– the involvement of representative intended OPERATORS (see D.4.3.2).
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 1 The MANUFACTURER should apply one or more methods for the USABILITY VALIDATION of PRIMARY OPERATING
FUNCTIONS of the ME EQUIPMENT depending on the INTENDED USE. Examples of these methods are found in Clause
D.5.
NOTE 2 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:
– worst case USE SCENARIOS derived from:
• the application specification (see 6.2.2.1),
• predictable USE ERRORS, and
• the results of the RISK ANALYSIS; and
– USE SCENARIOS representing frequent application situations identified in the USABILITY
SPECIFICATION.
The USABILITY VALIDATION plan shall be recorded in the USABILITY ENGINEERING FILE.
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
6.2.6 * USABILITY VALIDATION
The MANUFACTURER shall validate OPERATOR-EQUIPMENT INTERFACE design according to the
USABILITY VALIDATION plan. The results shall be recorded, including any required design
modification needed to satisfy the criteria as defined in the USABILITY VALIDATION plan.
NOTE 1 The ACCOMPANYING DOCUMENTS are part of the ME EQUIPMENT and are also subject to activities for
validating USABILITY.
NOTE 2 Individuals that were not directly involved in the OPERATOR-EQUIPMENT INTERFACE design should be
involved in the USABILITY VALIDATION.
Compliance is checked by inspecting the USABILITY ENGINEERING FILE.

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Annex A
(informative)
General guidance and rationale

A.1 General guidance
This annex provides a concise rationale for the important requirements of this collateral
standard. Its purpose is to promote effective application of the collateral standard by
explaining the reasons for the requirements and provide additional guidance where
appropriate.
A.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclauses in this collateral standard,
with clause and subclause numbers parallel to those in the body of the document.
Definition 3.4 – OPERATOR-EQUIPMENT INTERFACE
The OPERATOR-EQUIPMENT INTERFACE includes all means of communication between the
ME EQUIPMENT to the OPERATOR and the OPERATOR to the ME EQUIPMENT. These means include,
but are not limited to:
– markings and ACCOMPANYING DOCUMENTS;
– lights;
– video displays;
– push buttons;
– touch screens;
– auditory and visual INFORMATION SIGNALS;
– ALARM SIGNALS;
– vibratory signals;
– keyboard and mouse; and
– haptic controls.
Definition 3.6 – PRIMARY OPERATING FUNCTION
For the purposes of this collateral standard, a PRIMARY OPERATING FUNCTION is a function that
is directly related to the BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME EQUIPMENT in
NORMAL USE or a function that is frequently used. Examples of PRIMARY OPERATING FUNCTION
that directly relate to BASIC SAFETY or ESSENTIAL PERFORMANCE include:
– inactivating an ALARM SIGNAL (temporarily or indefinitely);
– setting ALARM LIMITS;
– setting X-ray exposure parameters (e.g. kV , mA);
p
– setting infusion parameters (e.g. flow rate);
– setting gas flow rates and anaesthetic vaporizer concentration.

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Frequently used functions are included in the PRIMARY OPERATING FUNCTIONS because
inadequate USABILITY of the frequently used functions adds to OPERATORS’ workloads and can
increase the probability of USE ERRORS affecting safety-related functions. A collection of
relatively minor shortcomings in the design of OPERATOR-EQUIPMENT INTERFACES can raise the
probability of USE ERRORS and their consequences, particularly when they involve frequently
used functions. Examples of such shortcomings include poor labelling, ambiguous control-
display relationships, difficult to read indicators, connectors that lack the proper sha
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