IEC 60601-1-6:2010

IEC 60601-1-6 ®
Edition 3.1 2013-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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IEC 60601-1-6 ®
Edition 3.1 2013-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-1186-1

IEC 60601-1-6 ®
Edition 3.1 2013-10
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – 60601-1-6  IEC:2010+A1:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION TO THE AMENDMENT . 7
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 10
4.1 * Conditions for application to ME EQUIPMENT . 10
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT . 11
5 * Replacement of requirements given in IEC 62366 . 11
Annex A (informative) General guidance and rationale . 12
Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the
related elements in IEC 62366:2007 . 14
Annex C (informative) References to items of USABILITY provided in IEC 62366:2007
and their use in other standards . 22
Bibliography . 25
Index of defined terms used with this collateral standard . 27

Table B.1 – Mapping between the elements of IEC 60601-1-6:2006 and the related
4)
elements in IEC 62366:2007+A1— . 14
Table C.1 – References to items of USABILITY in IEC 62366 and their use in other
standards . 22

60601-1-6  IEC:2010+A1:2013 – 3 –
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
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

This Consolidated version of IEC 60601-1-6 bears the edition number 3.1. It consists of
the third edition (2010) [documents 62A/682/FDIS and 62A/689/RVD] and its amendment
1 (2013) [documents 62A/890/FDIS and 62A/898/RVD]. The technical content is identical
to the base edition and its amendment.
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions and deletions are displayed in red, with
deletions being struck through. A separate Final version with all changes accepted is
available in this publication.
This publication has been prepared for user convenience.

– 4 – 60601-1-6  IEC:2010+A1:2013
International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
This third edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance
hereafter referred to as the general standard.
This document cancels and replaces the second edition of IEC 60601-1-6 which has been
technically revised. To allow for equipment manufacturers and testing organizations to make
products and to equip themselves for conducting revised tests in accordance with this third
edition, it is recommended by SC 62A that the content of this document not be adopted for
mandatory implementation earlier than 3 years from the date of publication for equipment
newly designed and not earlier than 5 years from the date of publication for equipment
already in production.
This edition of IEC 60601-1-6 was revised to align with the USABILITY ENGINEERING PROCESS in
IEC 62366.
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 or instructions to modify requirements in IEC 62366: 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 numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 4.1 and 4.2 are all
subclauses of Clause 4).
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;
60601-1-6  IEC:2010+A1:2013 – 5 –
– “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 (*).
To assist the user of this collateral standard in migrating from IEC 60601-1-6:2006 to
1)
IEC 62366:2007+A1— , Table B.1 has been developed. This table maps the clauses and
subclause of IEC 60601-1-6:2006 to the comparable clauses and subclauses in
1)
IEC 62366:2007+A1— . To further assist the user of this collateral standard, Table C.1
relates certain elements of IEC 62366 to other standards, such as parts of the ISO 9241
series, which might be useful in meeting the requirements of IEC 62366.
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 the base publication and its amendment 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 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.

IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

—————————
1)
To be published
– 6 – 60601-1-6  IEC:2010+A1:2013
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. Much of ME EQUIPMENT developed
without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to
use. As healthcare evolves, less skilled OPERATORS including PATIENTS themselves are now
using MEDICAL ELECTRICAL EQUIPMENT while the MEDICAL ELECTRICAL EQUIPMENT itself is
becoming more complicated. In simpler times, the OPERATOR of the MEDICAL ELECTRICAL
EQUIPMENT might be able to cope with an ambiguous, difficult-to-use OPERATOR-EQUIPMENT
INTERFACE. The design of usable MEDICAL ELECTRICAL EQUIPMENT is a challenging endeavour.
The design of the OPERATOR-EQUIPMENT 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 be controlled by the MANUFACTURER. The
relationship of the USABILITY ENGINEERING PROCESS to the RISK MANAGEMENT PROCESS is
described in Figure A.1 of IEC 62366:2007.
The first and second editions of this collateral standard described a USABILITY ENGINEERING
PROCESS that was tailored to the needs of MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT.
They provided guidance on how to implement and execute the PROCESS to improve the safety
of MEDICAL ELECTRICAL EQUIPMENT.
Subclause 1.3 of IEC 60601-1:2005+A1:2012 states that, “Applicable collateral standards
become normative at the date of their publication and shall apply together with this standard.”
Consequently, the second edition of this collateral standard was developed specifically to
align with IEC 60601-1:2005 and published in 2006. All other relevant collateral standards
within the jurisdiction of IEC Subcommittee 62A also were updated and republished between
2006 and 2007 except for IEC 60601-1-1 and IEC 60601-1-4. These collateral standards were
not revised because their requirements were integrated into IEC 60601-1:2005.
After the second edition of this collateral standard was published, IEC Subcommittee 62A, in
partnership with ISO Technical Committee 210, developed and published a general usability
engineering standard applicable to all MEDICAL DEVICES—IEC 62366:2007. IEC 62366 is based
on IEC 60601-1-6, but was refined using the experience gained with applying the first edition
of IEC 60601-1-6. Although the processes described in IEC 60601-1-6:2006 and
IEC 62366:2007 are very similar, they are not identical.
At its Auckland meeting in 2008, IEC Technical Committee 62 approved a project to revise
IEC 60601-1-6 so that it would reduce or eliminate duplication with IEC 62366 and also create
a bridge between IEC 60601-1 and IEC 62366. This third edition of IEC 60601-1-6 creates
that bridge and will enable a MANUFACTURER to conform to the requirements in IEC 60601-
1:2005 that make normative reference to IEC 60601-1-6 by employing a USABILITY
ENGINEERING PROCESS complying with IEC 62366:2007. At a point in the future, that bridge can
be eliminated by revising or amending IEC 60601-1 to include a direct reference to IEC 62366
and, as necessary, adding any additional requirements that are specific to medical electrical
equipment, such as those contained in Clauses 4 and 5 of this collateral standard, to
IEC 60601-1 or as a normative annex to IEC 62366.
This collateral standard is intended to be useful not only for MANUFACTURER(S) of MEDICAL
ELECTRICAL EQUIPMENT, but also for technical committees responsible for the preparation of
particular MEDICAL ELECTRICAL EQUIPMENT standards. It should be noted that clinical
investigations conducted according to ISO 14155-1 and usability testing for verification or
validation according to this standard are two fundamentally different activities and should not
be confused.
60601-1-6  IEC:2010+A1:2013 – 7 –
Amendment 1 removes the reference to the complete life-cycle process (including post-
production monitoring and surveillance). IEC 60601 (the series) is confined to performing a
TYPE TEST of ME EQUIPMENT. It does not extend to the entire life cycle including post-
production monitoring and periodic maintenance of the USABILITY ENGINEERING PROCESS.

– 8 – 60601-1-6  IEC:2010+A1:2013
INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge
that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make
normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS
complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process
elements that are inconsistent with a TYPE TEST.
This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that
are required for compliance with the IEC 60601 series.

60601-1-6  IEC:2010+A1:2013 – 9 –
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 a PROCESS for a MANUFACTURER to analyse, specify,
design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL
of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.
PERFORMANCE
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 collateral standard has been complied
with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met
(see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated
with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE
EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).
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 (IEC 60601-1:2005+A1:2012);
• "this collateral standard" designates IEC 60601-1-6 alone (IEC 60601-1-6:2010+A1:2013);
• "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.

– 10 – 60601-1-6  IEC:2010+A1:2013
NOTE The way in which these referenced documents are cited determines the extent (in whole or in part) to
which they apply.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
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
Amendment 1:2012
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
2)
Amendment 1:—
ISO 14971:2007, 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-
2)
1:2005+A1:2012, IEC 60601-1-8:2006+A1:2012, IEC 62366:2007+A1:— and the following
definitions apply.
NOTE An index of defined terms used with this collateral standard is found beginning on page 24 27.
3.1
* 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.
3.2
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
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
USE and USE ERROR are acceptable. See also 7.1.1 and 12.2 of the general standard.
Compliance with this subclause is considered to exist when compliance with 4.2 and other
clauses and subclauses of this collateral standard is demonstrated.
—————————
2)
To be published
60601-1-6  IEC:2010+A1:2013 – 11 –
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT
3)
A USABILITY ENGINEERING PROCESS complying with IEC 62366:2007+A1:— shall be performed
except:
– the planning for and execution of production and post-production monitoring in the context
of applying the USABILITY ENGINEERING PROCESS within the framework of ISO 14971, and
– maintenance of the USABILITY ENGINEERING PROCESS.
In applying IEC 62366, the terms in this collateral standard and those in IEC 60601-
1:2005+A1:2012 shall be used as follows:
• The term “MEDICAL DEVICE” shall assume the same meaning as ME EQUIPMENT.
• The term “USER” shall assume the same meaning as OPERATOR.
• The term “PATIENT” shall include animals.
• The term "SAFETY” shall assume the same meaning as BASIC SAFETY and ESSENTIAL
PERFORMANCE.
• The term “USER INTERFACE” shall assume the same meaning as OPERATOR-EQUIPMENT
INTERFACE.
• The term “USER PROFILE” shall assume the same meaning as OPERATOR PROFILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE. Evidence of
compliance with this clause and all requirements of this standard referring to inspection of the
USABILITY ENGINEERING FILE are satisfied if the MANUFACTURER has:
– established a USABILITY ENGINEERING PROCESS;
– established acceptance criteria for USABILITY; and
– demonstrated that the acceptance criteria for USABILITY have been met.
5 * Replacement of requirements given in IEC 62366
In addition to requirements of IEC 62366 the following replacements shall apply:
Replace the first two paragraphs including NOTES 1 and 2 of Clause 6 of
3)
IEC 62366:2007+A1— by:
The instructions for use shall include a brief description of the ME EQUIPMENT, its physical
operating principles and significant physical and performance characteristics relevant to its
USABILITY. The same information shall also be included in the technical description, if this is
provided as a separate document.
NOTE An important purpose of this description is to help the OPERATOR to develop a correct mental model of the
ME EQUIPMENT.
The instructions for use shall contain a summary of the application specification.
—————————
3)
To be published
– 12 – 60601-1-6  IEC:2010+A1:2013
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.
Subclause 1.1 – Scope
This collateral standard focuses on the USABILITY of the OPERATOR-EQUIPMENT INTERFACE of
ME EQUIPMENT. USABILITY, in general, includes attributes such as OPERATOR satisfaction and
EFFICIENCY. These attributes might be related to the BASIC SAFETY or ESSENTIAL PERFORMANCE
of the ME EQUIPMENT. A degradation of these attributes can increase the probability of USE
ERROR. Examples of attributes that are not considered could include the aesthetics of the
ME EQUIPMENT or the amount of supplies consumed.
Definition 3.1 – 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.
ME EQUIPMENT
Subclause 4.1 – Conditions for application to
This collateral standard specifies requirements addressing particular RISKS associated with
USABILITY. When these requirements are complied with, the RESIDUAL RISKS associated with
USABILITY are presumed to be acceptable unless there is OBJECTIVE EVIDENCE to the contrary.
This follows from 4.2 of the general standard, which states “Where this standard or any of its
collateral or particular standards specify verifiable requirements addressing particular RISKS,
and these requirements are complied with, the RESIDUAL RISKS addressed by these

60601-1-6  IEC:2010+A1:2013 – 13 –
requirements shall be presumed to be acceptable unless there is OBJECTIVE EVIDENCE to the
contrary.”
The criteria for judging RISK acceptability are established by the USABILITY VALIDATION plan,
which specifies the criteria for determining successful VALIDATION of the USABILITY of the
PRIMARY OPERATING FUNCTIONS.
Subclause 4.2 – USABILITY ENGINEERING PROCESS for ME EQUIPMENT
The first edition of this collateral standard was published in 2004, and introduced a USABILITY
ENGINEERING PROCESS tailored to ME EQUIPMENT. The second edition was published in 2006
and was intended to align the collateral standard with the third edition of IEC 60601-1 —
principally the inclusion in IEC 60601-1:2005 of the requirement to conduct a RISK
MANAGEMENT PROCESS following ISO 14971. The USABILITY ENGINEERING PROCESS described in
the second edition of IEC 60601-1-6 was little altered from that in the first edition.
Shortly after the publication of the 2004 edition of IEC 60601-1-6, IEC Subcommittee 62A
formed a joint project with ISO Technical Committee 210 to develop a general USABILITY
ENGINEERING PROCESS standard applicable to all MEDICAL DEVICES as defined in the ISO quality
system standard, ISO 13485:2003. This project was similar in scope to the effort that took the
RISK MANAGEMENT PROCESS described in IEC 60601-1-4 and generalized it to produce
ISO 14971. The result of the joint IEC/SC 62A – ISO/TC 210 USABILITY standard project was
IEC 62366:2007.
While the USABILITY ENGINEERING PROCESS described in IEC 62366 is more mature and refined
than the PROCESS in the second edition of IEC 60601-1-6, it is fundamentally the same
PROCESS involving the same elements.
The scope of IEC 60601-1 and of this collateral standard is confined to performing a TYPE
TEST of ME EQUIPMENT; it does not extend to life-cycle monitoring. For this reason, the
monitoring of production and post-production information and the planning thereof, as
required by the ISO 14971 framework, is excluded from the USABILITY ENGINEERING PROCESS
described in this standard. The requirement in IEC 62366 for periodic maintenance of the
USABILITY ENGINEERING PROCESS is also excluded.
As with the RISK MANAGEMENT PROCESS before it, the existence of a generalized standard for
USABILITY ENGINEERING eliminates the need for much, but not all, of the content in the second
edition of IEC 60601-1-6. For example, IEC 62366 defines the USER as the “person using, i.e.
operating or handling, the MEDICAL DEVICE”. This definition includes those who clean, maintain
or install the MEDICAL DEVICE. In IEC 60601-1:2005+A1:2012, persons performing those
functions are described as SERVICE PERSONNEL. This subclause bridges between the general
PROCESS requirement in IEC 62366 and the specific application to ME EQUIPMENT.
Clause 5 – Replacement of requirements given in IEC 62366
Clause 6 of IEC 62366:2007 specifies the general requirements for the material to be included
in the ACCOMPANYING DOCUMENT, if such a document is provided. The ACCOMPANYING
DOCUMENT is required to include a summary of the application specification (see 5.1 of
IEC 62366). This replacement paragraph clarifies that for ME EQUIPMENT the summary is
described in the same terms used in subclause 7.9.2.5 of IEC 60601-1:2005+A1:2012 to
specify the ME EQUIPMENT description.
In IEC 60601-1, the ACCOMPANYING DOCUMENTS consist of the instructions for use and the
technical description. IEC 62366, on the other hand, discusses the ACCOMPANYING DOCUMENT
without specifically identifying any sub-parts. IEC 60601-1 anticipates that the instructions for
use and the technical description can be provided as separate physical documents. If they
are, then the summary of the application specification is required to appear in both
documents.
– 14 – 60601-1-6  IEC:2010+A1:2013
Annex B
(informative)
Mapping between the elements of IEC 60601-1-6:2006 and
the related elements in IEC 62366:2007

This annex contains a mapping of the clauses and subclause of IEC 60601-1-6:2006 to the
4)
comparable clauses and subclauses in IEC 62366:2007+A1— . Table B.1 is intended to
provide a tool to assist users of IEC 60601-1-6:2006 to trace requirements between that
4)
.
edition and their equivalent requirements in IEC 62366:2007+A1—
Table B.1 – Mapping between the elements of IEC 60601-1-6:2006
4)
and the related elements in IEC 62366:2007+A1—
Related elements in
4)
IEC 60601-1-6:2006 IEC 62366:2007+A1—
Clause Title Clause Title
1 Scope, object and related standards 1 Scope
4)
NOTE IEC 62366:2007+A1— applies to
MEDICAL DEVICES as defined in 3.11. That
definition is identical to that in
ISO 13485:2003.
2 Normative references 2 Normative references
3 Terms and definitions 3 Terms and definitions
3.1 ABNORMAL USE 3.1 ABNORMAL USE
IEC 60601-1: ACCOMPANYING DOCUMENT 3.2 ACCOMPANYING DOCUMENT
2005+A1:2012,
3.4
IEC 60601-1-8: ALARM LIMIT 3.3 ALARM LIMIT
2006+A1:2012,
3.3
IEC 60601-1-8: ALARM OFF 3.4 ALARM OFF
2006+A1:2012,
3.4
IEC 60601-1-8: ALARM SIGNAL 3.5 ALARM SIGNAL
2006+A1:2012,
3.9
IEC 60601-1-8: ALARM SYSTEM 3.6 ALARM SYSTEM
2006+A1:2012,
3.11
IEC 60601-1: BASIC SAFETY
2005+A1:2012,
SAFETY
3.10
ISO 14971:
NOTE SAFETY is used as defined term in
2007, 2.24
IEC 60601-1: ESSENTIAL PERFORMANCE
IEC 62366.
2005+A1:2012,
3.27
3.7 CORRECT USE
NOTE This is a new term in IEC 62366, and
is defined as “NORMAL USE without USE ERROR.”
3.2 EFFECTIVENESS 3.8 EFFECTIVENESS
3.3 EFFICIENCY 3.9 EFFICIENCY
—————————
4)
To be published
60601-1-6  IEC:2010+A1:2013 – 15 –
Table B.1 (continued)
Related elements in
5)
IEC 60601-1-6:2006
IEC 62366:2007+A1—
Clause Title Clause Title
NOTE Not a defined term in IEC 62366.
IEC 60601-1: HAND-HELD
2005+A1:2012,
3.37
IEC 60601-1: HARM ISO 14971: HARM
2005+A1:2012, 2007, 2.2
3.38
IEC 60601-1: HAZARD ISO 14971: HAZARD
2005+A1:2012, 2007, 2.3
3.39
IEC 60601-1: HAZARDOUS SITUATION ISO 14971: HAZARDOUS SITUATION
2005+A1:2012, 2007, 2.4
3.40
IEC 60601-1-8: INFORMATION SIGNAL 3.10 INFORMATION SIGNAL
2006+A1:2012,
3.23
IEC 60601-1: INTENDED USE ISO 14971: INTENDED USE
2005+A1:2012, 2007, 2.5
3.44
IEC 60601-1: MANUFACTURER ISO 14971: MANUFACTURER
2005+A1:2012, 2007, 2.8
3.55
IEC 60601-1: MEDICAL ELECTRICAL EQUIPMENT 3.11 MEDICAL DEVICE
2005+A1:2012,
3.63
IEC 60601-1: NORMAL USE 3.12 NORMAL USE
2005+A1:2012,
NOTE The phrase, “or in accordance with
3.71
generally accepted practice for those MEDICAL
DEVICES provided without instructions for use”
has been added to deal with MEDICAL DEVICES,
such as simple surgical instruments that are
not accompanied by instructions for use.
IEC 60601-1: OBJECTIVE EVIDENCE ISO 14971: OBJECTIVE EVIDENCE
2005+A1:2012, 2007, 2.10
3.72
IEC 60601-1: OPERATOR 3.23 USER
2005+A1:2012,
NOTE In IEC 62366, the USER includes but is
3.73
not limited to cleaners, maintainers and
installers. In IEC 60601-1:2005+A1:2012,
individuals who install, assemble, maintain or
repair ME EQUIPMENT are described as “SERVICE
PERSONNEL.”
3.4 OPERATOR-EQUIPMENT INTERFACE 3.24 USER INTERFACE
NOTE The word “communicate” was replaced
by “interact”.
3.5 OPERATOR PROFILE 3.25 USER PROFILE
IEC 60601-1: PATIENT 3.13 PATIENT
2005+A1:2012,
NOTE “Animal” has been deleted from the
3.76
IEC 60601-1 definition.
3.6 PRIMARY OPERATING FUNCTION 3.14 PRIMARY OPERATING FUNCTION
IEC 60601-1: PROCESS ISO 14971: PROCESS
2005+A1:2012, 2007, 2.13
3.89
NOTE Not a defined term in IEC 62366.
3.7 REASONABLY FORESEEABLE MISUSE

—————————
5)
To be published
– 16 – 60601-1-6  IEC:2010+A1:2013
Table B.1 (continued)
Related elements in
6)
IEC 60601-1-6:2006
IEC 62366:2007+A1—
Clause Title Clause Title
IEC 60601-1- REMINDER SIGNAL 3.15 REMINDER SIGNAL
8:2006
+A1:2012, 3.34
IEC 60601-1: RESIDUAL RISK ISO 14971: RESIDUAL RISK
2005+A1:2012, 2007, 2.15
3.100
IEC 60601-1: RESPONSIBLE ORGANIZATION 3.16 RESPONSIBLE ORGANIZATION
2005+A1:2012,
3.101
IEC 60601-1: RISK ISO 14971: RISK
2005+A1:2012, 2007, 2.16
3.102
IEC 60601-1: RISK ANALYSIS ISO 14971: RISK ANALYSIS
2005+A1:2012, 2007, 2.17
3.103
IEC 60601-1: RISK CONTROL ISO 14971: RISK CONTROL
2005+A1:2012, 2007, 2.19
3.105
IEC 60601-1: RISK EVALUATION ISO 14971: RISK EVALUATION
2005+A1:2012, 2007, 2.21
3.106
IEC 60601-1: RISK MANAGEMENT ISO 14971: RISK MANAGEMENT
2005+A1:2012, 2007, 2.22
3.107
IEC 60601-1: RISK MANAGEMENT FILE ISO 14971: RISK MANAGEMENT FILE
2005+A1:2012, 2007, 2.23
3.108
IEC 60601-1, SEVERITY ISO 14971: SEVERITY
2005+A1:2012, 2007, 2.25
3.114
NOTE Not a defined term in IEC 62366.
3.8 TRAINING
3.9 USE ERROR 3.21 USE ERROR
3.10 USE SCENARIO 3.22 USE SCENARIO
NOTE The phrase “used to specify and test
the USABILITY of the ME EQUIPMENT” is replaced
by “as performed by a specified USER in a
specified environment” to make the definition
more general.
3.11 USABILITY 3.17 USABILITY
NOTE 1 The phrase “of the USER INTERFACE”
has been inserted into the definition.
NOTE 2 Impaired EFFICIENCY can also lead to
USE ERRORS. The OPERATOR might be induced
to take inappropriate short cuts if the
ME EQUIPMENT does not meet their
expectations.
3.12 USABILITY ENGINEERING 3.18 USABILITY ENGINEERING
3.13 USABILITY ENGINEERING FILE 3.19 USABILITY ENGINEERING FILE
3.14 USABILITY SPECIFICATION 3.20 USABILITY SPECIFICATION
3.15 VALIDATION 3.26 VALIDATION

—————————
6)
To be published
60601-1-6  IEC:2010+A1:2013 – 17 –
Table B.1 (continued)
Related elements in
7)
IEC 60601-1-6:2006
IEC 62366:2007+A1—
Clause Title Clause Title
IEC 60601-1: VERIFICATION ISO 14971: VERIFICATION
2005+A1:2012, 2007, 2.28
3.138
3.27 USER INTERFACE OF UNKNOWN
PROVENANCE
UOUP
NOTE Amendment 1 to IEC 62366 added a
new term that was not in IEC 60601-1.6:2006.
4 General requirements 4 Principles
4.1 Conditions for application to 4.1.2 RESIDUAL RISK
ME EQUIPMENT
This requirement is covered in 4.1 of this
collateral standard as well as in 4.1.2 of
IEC 62366.
NOTE This subclause in IEC 62366 mimics
the statement in the fourth bullet of 4.2 of
IEC 60601-1:2005+A1:2012 and closes the
loop with respect to the acceptability of
RESIDUAL RISKS associated with USABILITY when
the process described in IEC 62366 has been
complied with and the acceptance criteria
document in the USABILITY VALIDATION plan have
been met.
5.3.1 Identification of characteristics related to
SAFETY
NOTE In IEC 62366, the list of items to be
considered in that part of the RISK ANALYSIS
specified in ISO 14971:2007, 4.2 has been
reduced to:
– the application specification including the
user profile(s); and
– the frequently used functions
...

IEC 60601-1-6 ®
Edition 3.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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IEC 60601-1-6 ®
Edition 3.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8706-4

IEC 60601-1-6 ®
Edition 3.2 2020-07
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – IEC 60601-1-6:2010+AMD1:2013
+AMD2:2020 CSV  IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 10
4 General requirements . 11
4.1 * Conditions for application to ME EQUIPMENT . 11
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT . 11
5 * Replacement of requirements given in IEC 62366 ME EQUIPMENT ACCOMPANYING
DOCUMENTS . 12
Annex A (informative) General guidance and rationale . 14
Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the
related elements in IEC 62366:2007 .
Annex C (informative) References to items of USABILITY provided in IEC 62366:2007
and their use in other standards .
Bibliography . 28
Index of defined terms used with this collateral standard . 30

Table B.1 – Mapping between the elements of IEC 60601-1-6:2006 and the related
4)
elements in IEC 62366:2007+A1— .
Table C.1 – References to items of USABILITY in IEC 62366 and their use in other
standards .

+AMD2:2020 CSV  IEC 2020
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
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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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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
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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.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-1-6 edition 3.2 contains the third edition (2010-01) [documents 62A/682/FDIS
and 62A/689/RVD], its amendment 1 (2013-10) [documents 62A/890/FDIS and
62A/898/RVD] and its amendment 2 (2020-07) [documents 62A/1391/FDIS and
62A/1406/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
– 4 – IEC 60601-1-6:2010+AMD1:2013
+AMD2:2020 CSV  IEC 2020
International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
This third edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance
hereafter referred to as the general standard.
This document cancels and replaces the second edition of IEC 60601-1-6 which has been
technically revised. To allow for equipment manufacturers and testing organizations to make
products and to equip themselves for conducting revised tests in accordance with this third
edition, it is recommended by SC 62A that the content of this document not be adopted for
mandatory implementation earlier than 3 years from the date of publication for equipment
newly designed and not earlier than 5 years from the date of publication for equipment
already in production.
This edition of IEC 60601-1-6 was revised to align with the USABILITY ENGINEERING PROCESS in
IEC 62366-1.
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 or instructions to modify requirements in IEC 62366-1: 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 numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 4.1 and 4.2 are all
subclauses of Clause 4).
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;
+AMD2:2020 CSV  IEC 2020
– “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 (*).
To assist the user of this collateral standard in migrating from IEC 60601-1-6:2006 to
1)
IEC 62366:2007+A1— , Table B.1 has been developed. This table maps the clauses and
subclause of IEC 60601-1-6:2006 to the comparable clauses and subclauses in
1)
IEC 62366:2007+A1— . To further assist the user of this collateral standard, Table C.1
relates certain elements of IEC 62366 to other standards, such as parts of the ISO 9241
series, which might be useful in meeting the requirements of IEC 62366.
To assist the user to implement the USABILITY ENGINEERING PROCESS, the Technical Report
2)
IEC TR 62366-2 [1] is available. IEC TR 62366-2 contains tutorial information to assist
MANUFACTURERS in complying with this standard. The Technical Report also goes beyond
safety-related aspects and offers more detailed descriptions of USABILITY ENGINEERING
methods that can be applied to the development of ME EQUIPMENT.
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 the base publication and its amendments 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 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.

IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

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2)
Figures in square brackets refer to the Bibliography.

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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. Much of ME EQUIPMENT developed
without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to
use. As healthcare evolves, less skilled OPERATORS including PATIENTS themselves are now
using MEDICAL ELECTRICAL EQUIPMENT while the MEDICAL ELECTRICAL EQUIPMENT itself is
becoming more complicated. In simpler times, the OPERATOR of the MEDICAL ELECTRICAL
EQUIPMENT might be able to cope with an ambiguous, difficult-to-use OPERATOR-EQUIPMENT
INTERFACE. The design of usable MEDICAL ELECTRICAL EQUIPMENT is a challenging endeavour.
The design of the OPERATOR-EQUIPMENT INTERFACE to achieve adequate (safe) safe use
(adequate 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 be controlled by the MANUFACTURER. The
relationship of the USABILITY ENGINEERING PROCESS to the RISK MANAGEMENT PROCESS is
described in Figure A.1 of IEC 62366:2007 Figure A.4 of IEC 62366-1:2015.
The first and second editions of this collateral standard described a USABILITY ENGINEERING
PROCESS that was tailored to the needs of MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT.
They provided guidance on how to implement and execute the PROCESS to improve the safety
of MEDICAL ELECTRICAL EQUIPMENT.
Subclause 1.3 of IEC 60601-1:2005+A1:2012 states that, “Applicable collateral standards
become normative at the date of their publication and shall apply together with this standard.”
Consequently, the second edition of this collateral standard was developed specifically to
align with IEC 60601-1:2005 and published in 2006. All other relevant collateral standards
within the jurisdiction of IEC Subcommittee 62A also were updated and republished between
2006 and 2007 except for IEC 60601-1-1 and IEC 60601-1-4. These collateral standards were
not revised because their requirements were integrated into IEC 60601-1:2005.
After the second edition of this collateral standard was published, IEC Subcommittee 62A, in
partnership with ISO Technical Committee 210, developed and published a general usability
engineering standard applicable to all MEDICAL DEVICES—IEC 62366:2007. IEC 62366 is based
on IEC 60601-1-6, but was refined using the experience gained with applying the first edition
of IEC 60601-1-6. Although the processes described in IEC 60601-1-6:2006 and
IEC 62366:2007 are very similar, they are not identical.
At its Auckland meeting in 2008, IEC Technical Committee 62 approved a project to revise
IEC 60601-1-6 so that it would reduce or eliminate duplication with IEC 62366 and also create
a bridge between IEC 60601-1 and IEC 62366. This third edition of IEC 60601-1-6 creates
that bridge and will enable a MANUFACTURER to conform to the requirements in IEC 60601-
1:2005 that make normative reference to IEC 60601-1-6 by employing a USABILITY
ENGINEERING PROCESS complying with IEC 62366:2007. At a point in the future, that bridge can
be eliminated by revising or amending IEC 60601-1 to include a direct reference to IEC 62366
and, as necessary, adding any additional requirements that are specific to medical electrical
equipment, such as those contained in Clauses 4 and 5 of this collateral standard, to
IEC 60601-1 or as a normative annex to IEC 62366.
This collateral standard is intended to be useful not only for MANUFACTURER(S) of MEDICAL
ELECTRICAL EQUIPMENT, but also for technical committees responsible for the preparation of
particular MEDICAL ELECTRICAL EQUIPMENT standards. It should be noted that clinical
investigations conducted according to ISO 14155-1 [2] and usability testing for verification or
validation USABILITY TESTS for FORMATIVE EVALUATION or SUMMATIVE EVALUATION according to
this standard are two fundamentally different activities and should not be confused.

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Amendment 1 removes the reference to the complete life-cycle process (including post-
production monitoring and surveillance). IEC 60601 (the series) is confined to performing a
TYPE TEST of ME EQUIPMENT. It does not extend to the entire life cycle including post-
production monitoring and periodic maintenance of the USABILITY ENGINEERING PROCESS.

INTRODUCTION to Amendment 1
The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge
that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make
normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS
complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process
elements that are inconsistent with a TYPE TEST.
This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that
are required for compliance with the IEC 60601 series.

INTRODUCTION to Amendment 2
The third edition of IEC 60601-1-6 was published in 2010 and amended in 2013. Since the
publication of IEC 60601-1-6:2010+A1:2013, the IEC Subcommittee (SC) 62A Secretariat has
been collecting issues from a variety of sources including comments from National
Committees. At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the
subcommittee initiated a process to identify high-priority issues that need to be considered in
an amendment and should not wait until the fourth edition of IEC 60601-1-6, which is
presently targeted for publication sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2
were those approved by a 2/3 majority of the National Committees present and voting at the
Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, nine items were
presented to the National Committees present. All nine items received the required 2/3
majority of the National Committees present and voting and have been included in the "short
list" for consideration in preparing Amendment 2. All remaining issues have been placed on a
"long list" for consideration in the fourth edition of IEC 60601-1-6.
The "short list" of issues was documented in the design specification for Amendment 2.
MEDICAL
Because these issues are closely related to the application of IEC 62366-1 to
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, the work was assigned to IEC/SC
62A-ISO/TC 210 Joint Working Group (JWG) 4. JWG 4 was directed to consider each issue
described in Clause 6 of the design specification and develop an appropriate solution for the
identified problem. That final solution in this amendment can encompass any technical
solution proposed by the author of the issue or it can involve a different solution developed by
the expert group. The expert group can also have recommended that no change to the
document was justified by the problem statement.
This amendment updates the references from the now obsolete IEC 62366:2007 to the current
USABILITY ENGINEERING PROCESS standard, IEC 62366-1:2015+A1:2020.
Because this is an amendment to IEC 60601-1-6:2010, the style in force at the time of
publication of IEC 60601-1-6 has been applied to this amendment. The style specified in
ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style
guidance would not result in additional editorial changes. For example, references to
amendments take the following form: "IEC 60601-1:2005+A1:2012+A2:2020".

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Users of this document should note that when constructing the dated references to specific
elements in a standard, such as definitions, amendments are only referenced if they modified
the text being cited. For example, if a reference is made to a definition that has not been
modified by an amendment, then the reference to the amendment is not included in the dated
reference.
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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 a PROCESS for a MANUFACTURER to analyse, specify,
design, VERIFY and VALIDATE USABILITY develop and evaluate the USABILITY, as it relates to
BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter
referred to as ME EQUIPMENT.
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 collateral standard has been complied
with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met
(see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated
with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE
EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied
with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL
is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the
PERFORMANCE
contrary.
NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.
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 (IEC 60601-1:2005+A1:2012),
including any amendments;
• "this collateral standard" designates IEC 60601-1-6 alone (IEC 60601-1-6:2010+A1:2013),
including any amendments;
• "this standard" designates the combination of the general standard and this collateral
standard.
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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.
NOTE The way in which these referenced documents are cited determines the extent (in whole or in part) to
which they apply.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
Amendment 2:2020
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
Amendment 1:2012
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
3)
Amendment 1:—
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
Amendment 1:2020
ISO 14971:20072019, 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-
3)
1:2005+A1:2012, IEC 60601-1-8:2006+A1:2012, IEC 62366:2007+A1:— and the following
definitions apply.
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, ISO 14971:2019 and the
following definitions apply.
NOTE An index of defined terms used with this collateral standard is found beginning on page 30.
3.1
* 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.
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means by which the OPERATOR and the ME EQUIPMENT interact
Note 1 to entry: The ACCOMPANYING DOCUMENTS are considered part of the ME EQUIPMENT and its OPERATOR
INTERFACE.
Note 2 to entry: OPERATOR INTERFACE includes all the elements of the ME EQUIPMENT with which the OPERATOR
interacts including the physical aspects of the ME EQUIPMENT 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, the MANUFACTURER may treat the combination of ME EQUIPMENT
and other equipment as a single OPERATOR INTERFACE.
Note 4 to entry: See IEC 62366-1:2015, 3.26.
3.2
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
summary of the mental, physical and demographic traits of the OPERATOR GROUP, as well as
characteristics, such as knowledge, skills and abilities, which can have a bearing on design
decisions
[SOURCE: IEC 62366-1:2015+A1:2020, definition 3.29, modified — Replaced "a USER GROUP"
with "the OPERATOR GROUP".]
3.3
OPERATOR GROUP
subset of OPERATORS who are differentiated from other OPERATORS by factors that are likely to
influence their interactions with the ME EQUIPMENT
Note 1 to entry: Attributes of OPERATOR GROUPS can include age, culture, expertise.
[SOURCE: IEC 62366-1:2015+A1:2020, 3.25, modified – Replaced "USER" with "OPERATOR"
and "MEDICAL DEVICE" with "ME EQUIPMENT".]
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
USE and USE ERROR NORMAL USE, i.e. CORRECT USE and USE ERROR, are acceptable. See also
7.1.1 and 12.2 of the general standard.
Compliance with this subclause is considered to exist when compliance with 4.2 and other
clauses and subclauses of this collateral standard is demonstrated.
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT
4)
USABILITY ENGINEERING PROCESS complying with IEC 62366A1:— shall be performed
A
except:
the planning for and execution of production and post-production monitoring in the context
of applying the USABILITY ENGINEERING PROCESS within the framework of ISO 14971, and
maintenance of the USABILITY ENGINEERING PROCESS.
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In applying IEC 62366, the terms in this collateral standard and those in IEC 60601-
1:2005+A1:2012 shall be used as follows:
• The term “MEDICAL DEVICE” shall assume the same meaning as ME EQUIPMENT.
• The term “USER” shall assume the same meaning as OPERATOR.
• The term “PATIENT” shall include animals.
• The term "SAFETY” shall assume the same meaning as BASIC SAFETY and ESSENTIAL
PERFORMANCE.
• The term “USER INTERFACE” shall assume the same meaning as OPERATOR-EQUIPMENT
INTERFACE.
• The term “USER PROFILE” shall assume the same meaning as OPERATOR PROFILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE. Evidence of
compliance with this clause and all requirements of this standard referring to inspection of the
USABILITY ENGINEERING FILE are satisfied if the MANUFACTURER has:
– established a USABILITY ENGINEERING PROCESS;
– established acceptance criteria for USABILITY; and
– demonstrated that the acceptance criteria for USABILITY have been met.
A USABILITY ENGINEERING PROCESS complying with IEC 62366-1:2015+A1:2020 shall be
performed except:
‒ the planning for and execution of production and POST-PRODUCTION monitoring in the
context of applying the USABILITY ENGINEERING PROCESS within the framework of
ISO 14971, and
‒ maintenance of the USABILITY ENGINEERING PROCESS.
In applying IEC 62366-1:2015+A1:2020, the terms in this collateral standard and those in
IEC 60601-1:2005+A1:2012+A2:2020 shall be used as follows.
‒ The term "ACCOMPANYING DOCUMENTATION" shall assume the same meaning as
ACCOMPANYING DOCUMENTS.
‒ The term "MEDICAL DEVICE" shall assume the same meaning as ME EQUIPMENT.
‒ The term "USER" shall assume the same meaning as OPERATOR.
‒ The term "PATIENT" shall include animals.
‒ The term "SAFETY" shall assume the same meaning as BASIC SAFETY and ESSENTIAL
PERFORMANCE.
USER GROUP" shall assume the same meaning as OPERATOR GROUP.
‒ The term "
‒ The term "USER INTERFACE" shall assume the same meaning as OPERATOR INTERFACE.
USER PROFILE" shall assume the same meaning as OPERATOR PROFILE.
‒ The term "
Compliance is checked by inspection of the USABILITY ENGINEERING FILE. Evidence of
compliance with this clause and all requirements of this standard referring to inspection of the
USABILITY ENGINEERING FILE are satisfied if the MANUFACTURER has demonstrated compliance
with IEC 62366-1:2015+A1:2020.
5 * Replacement of requirements given in IEC 62366 ME EQUIPMENT
ACCOMPANYING DOCUMENTS
In addition to requirements of IEC 62366 the following replacements shall apply:

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Replace the first two paragraphs including NOTES 1 and 2 of Clause 6 of
5)
IEC 62366:2007+A1— by:
The instructions for use shall include a brief description of the ME EQUIPMENT, its physical
operating principles and significant physical and performance characteristics relevant to its
USABILITY use. The same information shall also be included in the technical description, if this
is provided as a separate document.
NOTE An important purpose of this description is to help the OPERATOR to develop a correct mental model of the
ME EQUIPMENT.
The instructions for use shall contain a summary of the application specification USE
SPECIFICATION as specified in IEC 62366-1:2015+A1:2020, 5.1.
Compliance is checked by inspection.

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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.
Subclause 1.1 – Scope
This collateral standard focuses on the USABILITY of the OPERATOR-EQUIPMENT INTERFACE of
ME EQUIPMENT. USABILITY, in general, includes attributes such as OPERATOR satisfaction and
EFFICIENCY. These attributes might be related to the BASIC SAFETY or ESSENTIAL PERFORMANCE
of the ME EQUIPMENT. A degradation of these attributes can increase the probability of USE
ERROR. Examples of attributes that are not considered could include the aesthetics of the
ME EQUIPMENT or the amount of supplies consumed.
Definition 3.1 – 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.
– elements that require manual manipulation;
– cables and tubing connections;
– accessories;
– handles;
– force required to move the weight;
– work surface height;
– dimensions that affect reach requirements;

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– markings and ACCOMPANYING DOCUMENTS;
– video displays;
– push buttons;
– touch screens;
– auditory, vibratory, tactile, and visual signals to inform OPERATORS;
– voice recognition;
– keyboard and mouse; and
– haptic controls.
Subclause 4.1 – Conditions for application to ME EQUIPMENT
This collateral standard specifies requirements addressing particular RISKS associated with
USABILITY use-related RISKS. When these requirements are complied with, the RESIDUAL RISKS
associated with USABILITY use-related RISKS are presumed to be acceptable unless there is
OBJECTIVE EVIDENCE to the contrary. This follows from 4.2 of the general standard, which
states “Where this standard or any of its collateral or particular standards specify verifiable
requirements addressing particular RISKS, and these requirements are complied with, the
RESIDUAL RISKS addressed by these requirements shall be presumed to be acceptable unless
there is OBJECTIVE EVIDENCE to the contrary.”
The criteria for judging RISK acceptability are established by the USABILITY VALIDATION plan,
which specifies the criteria for determining successful VALIDATION of the USABILITY of the
PRIMARY OPERATING FUNCTIONS described in the SUMMATIVE EVALUATION plan, which specifies
the criteria for determining that the OPERATOR INTERFACE can be used safely.
Subclause 4.2 – USABILITY ENGINEERING PROCESS for ME EQUIPMENT
The first edition of this collateral standard was published in 2004, and introduced a USABILITY
tailored to ME EQUIPMENT. The second edition was published in 2006
ENGINEERING PROCESS
and was intended to align the collateral standard with the third edition of IEC 60601-1 —
principally the inclusion in IEC 60601-1:2005 of the requirement to conduct a RISK
MANAGEMENT PROCESS following ISO 14971. The USABILITY ENGINEERING PROCESS described in
the second edition of IEC 60601-1-6 was little altered from that in the first edition.
Shortly after the publication of the 2004 edition of IEC 60601-1-6, IEC Subcommittee 62A
USABILITY
formed a joint project with ISO Technical Committee 210 to develop a general
ENGINEERING PROCESS standard applicable to all MEDICAL DEVICES as defined in the ISO quality
system standard, ISO 13485:2003. This project was similar in scope to the effort that took the
RISK MANAGEMENT PROCESS described in IEC 60601-1-4 and generalized it to produce
ISO 14971. The result of the joint IEC/SC 62A – ISO/TC 210 USABILITY standard project was
IEC 62366:2007.
While the USABILITY ENGINEERING PROCESS described in IEC 62366 is more mature and refined
than the PROCESS in the second edition of IEC 60601-1-6, it is fundamentally the same
PROCESS involving the same elements.
The scope of IEC 60601-1 and of this collateral standard is confined to performing a TYPE
TEST of ME EQUIPMENT; it does not extend to life-cycle monitoring. For this reason, the
monitoring of production and post-production information and the planning thereof, as
required by the ISO 14971 framework, is excluded from the USABILITY ENGINEERING PROCESS
describ
...