IEC 60601-1:2005/AMD2:2020

IEC 60601-1 ®
Edition 3.0 2020-08
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

IEC 60601-1: 2005-12/AMD2: 2020-07(en)

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and definitions clause of
IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.

need further assistance, please contact the Customer Service

Centre: sales@iec.ch.
IEC 60601-1 ®
Edition 3.0 2020-08
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-8632-6

– 2 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
FOREWORD
This amendment 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.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1389/FDIS 62A/1404/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of the users of this document 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 document using a colour printer.

_____________
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The third edition of IEC 60601-1 was published in 2005 and amended in 2012. Since the
publication of IEC 60601-1:2005/AMD1:2012, the IEC Subcommittee (SC) 62A Secretariat has
been collecting issues from a variety of sources including comments from National Committees
and questions submitted to IEC/SC 62A/Working Group (WG) 14. 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 Amendment 2 and should not wait until the fourth
edition of IEC 60601-1, 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, 109 items were
presented to the National Committees present. A total of 78 items received the required 2/3
majority of the National Committees present and voting and were 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.
The "short list" of issues was documented in the design specification for Amendment 2. The
responsible expert groups were directed to consider each issue assigned to it 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 standard was justified by the problem
statement.
Because this is an amendment to the 2005 edition of IEC 60601-1, the style in force at the time
of publication of IEC 60601-1 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, notes to definitions are
designated as "NOTE" rather than "Note to entry" in Clause 3.
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.
– 4 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
INTRODUCTION
Add, after the existing last paragraph, the following paragraph:
Throughout this document, there are many references to, and requirements incorporated from
IEC 60950-1. Some of these requirements are derived from IEC 60950-1. For example, the
requirements for spaces filled by insulating compound in 8.9.3. In other cases, the requirements
are incorporated by a normative reference to IEC 60950-1:2005. For example, the requirements
for solid insulation forming a MEANS OF OPERATOR PROTECTION in 8.5.1.3. The requirements
incorporated by reference are primarily found in Clause 8 of this document, including many of
the tables used to determine the requirements for MEANS OF PROTECTION, primarily MEANS OF
OPERATOR PROTECTION and INSULATION CO-ORDINATION. The requirements incorporated by
reference are addressed in Amendment 2. The derived requirements will be addressed during
the development of the fourth edition of this document.
1.3 * Collateral standards
Replace the existing second paragraph with:
Applicable collateral standards shall apply together with this standard.
Delete the existing third paragraph.
1.4 * Particular standards
Replace the existing first paragraph with:
In the IEC 60601 series, particular standards specify BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for the particular ME EQUIPMENT and ME SYSTEMS. Particular standards may
modify, replace or delete requirements contained in this standard and applicable collateral
standards as appropriate for the particular ME EQUIPMENT and ME SYSTEMS under consideration.
Replace the existing second paragraph with:
A requirement of a particular standard takes priority over this standard and applicable collateral
standards.
2 * Normative references
Replace the existing second paragraph with:
ATTENTION: Additional collateral standards of the IEC 60601 series, which are issued subsequent
to publication of this standard, shall apply together with this standard when applicable. They shall
be considered as being included among the normative references below. See 1.3.
Replace the following existing references to IEC 60601-1-2, IEC 60601-1-3 modified by
Amendment 1, IEC 60601-1-6 and IEC 60601-1-8 by the following new references:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
Amendment 1:2020
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
ray equipment
Amendment 1:2013
© IEC 2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
Amendment 1:2013
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
Amendment 2:2020
Add the following new reference to the list:
IEC 60747-5-5:2007, Semiconductor devices – Discrete devices – Part 5-5: Optoelectronic
devices – Photocouplers
Replace, in the existing reference to IEC 60825-1,"2007" with "2014".
Replace the existing references to IEC 60950-1 and IEC 62304 by the following new references:
IEC 60950-1:2005, Information technology equipment – Safety – Part 1: General requirements
Amendment 1:2009
Amendment 2:2013
IEC 62304:2006, Medical device software – Software life cycle processes
Amendment 1:2015
Add the following normative references to the existing list:
IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes –
Safety requirements for portable sealed secondary lithium cells, and for batteries made from
them, for use in portable applications – Part 2: Lithium systems
IEC 62368-1:2018, Audio/video, information and communication technology equipment –
Part 1: Safety requirements
Replace the existing references to ISO 7000-DB:2004 by the following new reference:
ISO 7000, Graphical symbols for use on equipment
Replace, in the existing reference to ISO 7010, "2011" with "2019".
Replace, in the existing reference to ISO 14971, "2007" with "2019".
Replace, in the existing reference to ISO 15223-1, "2012" with "2016".
3 * Terminology and definitions
3.38
* HARM
Replace the existing term and definition, modified by Amendment 1, with:
3.38
* HARM
injury or damage to the health of people or animals, or damage to property or the environment
[ISO 14971:2019, definition 3.3, modified – "Or animals" added to the definition.]

– 6 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
3.39
HAZARD
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.4]
3.40
* HAZARDOUS SITUATION
Replace the existing term and definition, modified by Amendment 1, with:
3.40
* HAZARDOUS SITUATION
circumstance in which people, property, or the environment is/are exposed to one or more
HAZARDS
[ISO 14971:2019, definition 3.5, modified – Note 1 to entry deleted.]
3.44
INTENDED USE
INTENDED PURPOSE
Replace the existing term and definition, modified by Amendment 1, with:
3.44
INTENDED USE
INTENDED PURPOSE
use for which a product, PROCESS or service is intended according to the specifications,
instructions and information provided by the MANUFACTURER
NOTE 1 The intended medical indication, PATIENT population, part of the body or type of tissue interacted with, user
profile, use environment, and operating principle are typical elements of the INTENDED USE.
NOTE 2 INTENDED USE should not be confused with NORMAL USE. While both include the concept of use as intended
by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the
medical purpose, but maintenance, transport, etc. as well.
[ISO 14971:2019, definition 3.6, modified – Note 2 added.]
3.55
MANUFACTURER
Replace the existing term and definition, modified by Amendment 1, with:
3.55
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging, or labelling
of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM,
regardless of whether these operations are performed by that person himself or on his behalf
by another person(s)
NOTE 1 ISO 13485 [30] defines “labelling” as "label, instructions for use, and any other information that is related
to identification, technical description, INTENDED PURPOSE and proper use of the ME EQUIPMENT or ME SYSTEM, but
excluding shipping documents".
NOTE 2 “Adapting” includes making substantial modifications to ME EQUIPMENT or an ME SYSTEM already in use.
NOTE 3 In some jurisdictions, the RESPONSIBLE ORGANIZATION can be considered a MANUFACTURER when involved
in the activities described.
NOTE 4 Adapted from ISO 14971:2019, definition 3.9.

© IEC 2020
3.72
OBJECTIVE EVIDENCE
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.11]
3.88
PROCEDURE
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.13, modified – Note 1 to entry deleted.]
3.89
PROCESS
Replace the existing term and definition, modified by Amendment 1, with:
3.89
PROCESS
set of interrelated or interacting activities that use inputs to deliver an intended result
NOTE 1 Whether the “intended result” of a PROCESS is called output, product or service depends on the context of
the reference.
NOTE 2 Inputs to a PROCESS are generally the outputs of other PROCESSES and outputs of a PROCESS are generally
the inputs to other PROCESSES.
NOTE 3 Two or more interrelated and interacting PROCESSES in series can also be referred to as a PROCESS.
[ISO 14971:2019, definition 3.14]
3.98
RECORD
Add the following NOTES and replace the existing source statement for definition, modified by
Amendment 1, with:
NOTE 1 RECORDS can be used, for example, to formalize traceability and to provide evidence of VERIFICATION,
preventive action and corrective action.
NOTE 2 Generally RECORDS need not be under revision control.
[ISO 14971:2019, definition 3.16]
3.100
RESIDUAL RISK
Replace the existing term and definition, modified by Amendment 1, with:
3.100
RESIDUAL RISK
RISK remaining after RISK CONTROL measures have been implemented
[ISO 14971:2019, definition 3.17]
3.102
RISK
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.18]

– 8 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
3.103
RISK ANALYSIS
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.19]
3.104
RISK ASSESSMENT
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.20]
3.105
RISK CONTROL
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.21]
3.106
RISK EVALUATION
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.23]
3.107
RISK MANAGEMENT
Replace the existing term and definition, modified by Amendment 1, with:
3.107
RISK MANAGEMENT
systematic application of management policies, PROCEDURES and practices to the tasks of
analysing, evaluating, controlling and monitoring RISK
NOTE For the purposes of this standard, RISK MANAGEMENT does not include planning for or monitoring of production
and post-production information; whereas this is required for compliance with ISO 14971 (see 4.2.2).
[ISO 14971:2019, definition 3.24, modified – NOTE added.]
3.108
RISK MANAGEMENT FILE
Replace the existing NOTE and source statement for definition, modified by Amendment 1, with:
NOTE All safety related information including MANUFACTURER'S calculations, test results, etc. is considered to be
part of the RISK MANAGEMENT FILE. See also 4.2.
[ISO 14971:2019, definition 3.25, modified – NOTE added.]
3.114
SEVERITY
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.27]

© IEC 2020
3.136
USABILITY
Replace the existing term and definition, modified by Amendment 1, with:
3.136
USABILITY
characteristic of the OPERATOR interface that facilitates use and thereby establishes
effectiveness, efficiency, and OPERATOR satisfaction in the intended use environment
[IEC 62366-1:2015, definition 3.16, modified – Replace "user" with "OPERATOR" in two places
and delete Note 1 to entry.]
3.137
USABILITY ENGINEERING
Replace the existing term and definition, modified by Amendment 1, with:
3.137
USABILITY ENGINEERING
HUMAN FACTORS ENGINEERING
application of knowledge about human behaviour, abilities, limitations, and other characteristics
to the design of ME EQUIPMENT (including software), systems and tasks to achieve adequate
USABILITY
[IEC 62366-1:2015, definition 3.17, modified – Replace "medical devices" with "ME EQUIPMENT"
and delete Note 1 to entry.]
3.138
VERIFICATION
Replace the existing NOTES and source statement or definition, modified by Amendment 1,
with:
NOTE 1 The OBJECTIVE EVIDENCE needed for a VERIFICATION can be the result of an inspection or of other forms of
determination such as performing alternative calculations or reviewing documents.
NOTE 2 The activities carried out for VERIFICATION are sometimes called a qualification PROCESS.
NOTE 3 The word “verified” is used to designate the corresponding status.
[ISO 14971:2019, definition 3.31]
3.146
PRIMARY OPERATING FUNCTION
Replace the existing term and definition, added by Amendment 1, with:
3.146
PRIMARY OPERATING FUNCTION
function that involves OPERATOR interaction that is related to the safety of the ME EQUIPMENT
[IEC 62366-1:2015, definition 3.11, modified – Replace "user" with "OPERATOR" and "medical
device" with "ME EQUIPMENT", and delete Note 1 to entry and Note 2 to entry.]
3.147
USABILITY ENGINEERING FILE
For the existing definition, added by Amendment 1, replace "[IEC 62366:2007, definition 3.19]"
with "[IEC 62366-1:2015, definition 3.18]".

– 10 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
Add, after the existing definition 3.147, added by Amendment 1, the following new terms and
definitions:
3.148
ELECTROMAGNETIC DISTURBANCE
EM DISTURBANCE
any electromagnetic phenomenon that could degrade the performance of a device, equipment
or system
NOTE An ELECTROMAGNETIC DISTURBANCE can be electromagnetic noise, an unwanted signal or a change in the
propagation medium itself.
[IEC 60601-1-2:2014, definition 3.3]
3.149
HIGH PRIORITY
indicating that immediate OPERATOR response is required
NOTE 1 The priority is assigned through RISK ANALYSIS.
NOTE 2 Immediate implies the interruption of current workflow is expected.
[IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD2:2020, definition 3.22, modified – Internal
reference to IEC 60601-1-8, 6.1.2 in NOTE 1 deleted and bibliographic citations removed from
NOTE 2.]
3.150
* INFORMATION SIGNAL
any signal that is not an ALARM SIGNAL or a reminder signal
EXAMPLE 1 ECG waveform
EXAMPLE 2 SpO2 tone
EXAMPLE 3 Fluoroscopy beam-on indication
NOTE An advisory is a type of INFORMATION SIGNAL.
[SOURCE: IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD2:2020, definition 3.23]
3.151
LOW PRIORITY
indicating that OPERATOR awareness is required and future action might be needed
NOTE 1 The priority is assigned through RISK ANALYSIS.
NOTE 2 Awareness implies the planning of future workflow is expected.
[IEC 60601-1-8:2006/AMD2:2020, definition 3.27, modified – Internal reference to IEC 60601-
1-8, 6.1.2 in NOTE 1 deleted and bibliographic citations removed from NOTE 2.]
3.152
* MAXIMUM EQUIPMENT PRESSURE
the maximum gauge pressure to which a part of ME EQUIPMENT can be subjected in NORMAL
CONDITION and SINGLE FAULT CONDITION
3.153
MEDIUM PRIORITY
indicating that prompt OPERATOR response is required
NOTE 1 The priority is assigned through RISK ANALYSIS.

© IEC 2020
NOTE 2 Prompt implies the re-planning of current workflow is expected.
[IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD2:2020, definition 3.28, modified – Internal
reference to IEC 60601-1-8, 6.1.2 in NOTE 1 deleted and bibliographic citations removed from
NOTE 2.]
3.154
SAFETY SIGN
sign giving a general safety message, obtained by a combination of a colour and geometric
shape and which, by the addition of a graphical symbol, gives a general or particular safety
message
[ISO 7010:2019, definition 3.3, modified – Replace "gives a particular safety message" with "
gives a general or particular safety message".]
4.2.1 Introduction to RISK MANAGEMENT
Replace, in the existing second paragraph, added by Amendment 1, "ISO 14971" with
"ISO 14971:2019" (3 places).
4.2.2 General requirement for RISK MANAGEMENT
Replace, in the introductory paragraph before the dashes, added by Amendment 1,
"ISO 14971:2007" with "ISO 14971:2019".
Replace the existing first and second dashes, added by Amendment 1, with:
– the planning for and execution of production and post-production monitoring (subclause 4.1,
fourth dash, subclause 4.4, item g), and Clause 10 of ISO 14971:2019), and
– periodic reviews of the suitability of the RISK MANAGEMENT PROCESS (third paragraph of
ISO 14971:2019, subclause 4.2).
Figure 6 – Standard test finger (see 5.9.2.1)
Replace, in the existing NOTE 3 of this figure, the reference to "IEC 60950-1" with
"IEC 60950-1:2005".
6.3 * Protection against harmful ingress of water or particulate matter
Delete, in the existing title, the asterisk (*).
7.1.2 * Legibility of markings
Replace, in the existing first dash, "safety signs" with "SAFETY SIGNS".
7.2.3 * Consult ACCOMPANYING DOCUMENTS
Replace the existing subclause, modified by Amendment 1, with:
When the MANUFACTURER uses consulting the ACCOMPANYING DOCUMENTS as a primary RISK
CONTROL measure for a specific RISK (e.g. the instructions for use contain information for safety)
and the USABILITY ENGINEERING PROCESS determines that marking the ME EQUIPMENT is required
for the effectiveness of the RISK CONTROL, the ME EQUIPMENT shall be marked with the refer to
instruction manual/booklet mandatory action SAFETY SIGN ISO 7010-M002 (see Table D.2,
SAFETY SIGN 10).
Otherwise, symbol ISO 7000-1641 (2004-01) (see Table D.1, symbol 11) may be used to advise
the OPERATOR of the location of the instructions for use or to consult the ACCOMPANYING
DOCUMENTS.
– 12 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
7.2.5 ME EQUIPMENT intended to receive power from other equipment
Replace, in the existing second dash modified by Amendment 1, "safety sign" with "SAFETY SIGN"
in two places.
7.2.9 IP classification
Replace the existing second paragraph with:
If the IP classification of the ENCLOSURE of the ME EQUIPMENT or its parts is not specified (i.e.
IPXX) or is specified as IP00, IPX0 or IP0X, then the ME EQUIPMENT or its parts need not be
marked as such.
7.2.10 * APPLIED PARTS
Replace, in the final paragraph, "safety sign" with "SAFETY SIGN" in two places.
7.2.13 Physiological effects (safety signs and warning statements)
Replace, in the existing title, "safety signs" with "SAFETY SIGNS", and in the existing first
paragraph, "safety sign" with "SAFETY SIGN" in two places.
7.2.17 Protective packaging
Replace, in the existing third paragraph, "safety sign" with "SAFETY SIGN".
IGH VOLTAGE parts
7.3.2 * H
Replace, in the existing paragraph, modified by Amendment 1, "safety sign" with "SAFETY SIGN".
7.3.3 Batteries
Replace the existing third paragraph with:
Where lithium batteries or fuel cells are incorporated and where incorrect replacement (e.g.
reversed polarity) would result in a HAZARDOUS SITUATION (such as excessive temperatures, fire
or explosion), a warning indicating that replacement by inadequately trained personnel could
result in such a HAZARDOUS SITUATION shall be given in addition to the identifying marking
referring to information stated in the ACCOMPANYING DOCUMENTS.
7.3.7 Supply terminals
Delete, in the existing first paragraph, modified by Amendment 1, "unless it can be
demonstrated that no unacceptable RISK can result if connections are interchanged".
7.4.1 * Power switches
Delete, in the existing first paragraph modified by Amendment 1, "or its parts,".
Add, after the third dash of the existing third paragraph modified by Amendment 1, the following
paragraphs:
Switches used to control power to parts of ME EQUIPMENT shall have their “on” and “off”
positions:
– marked with symbols as specified above; or
– with IEC 60417-5264 (2002-10) and IEC 60417-5265 (2002-10) (see Table D.1, symbols 16
and 17); or
© IEC 2020
– indicated by an adjacent indicator light; or
– indicated by other unambiguous means.
A switch that brings the ME EQUIPMENT into the "stand-by" condition may be indicated by use of
symbol IEC 60417-5009 (2015-03) (see Table D.1, Symbol 29).
7.4.2 * Control devices
Delete, in the existing first paragraph, modified by Amendment 1, ", e.g. by use of symbols
IEC 60417-5264 (2002-10) and IEC 60417-5265 (2002-10) (see Table D.1, symbols 16 and 17)"
Delete the existing final paragraph, modified by Amendment 1.
7.5 Safety signs
Replace, in the existing title, "Safety signs" with "SAFETY SIGNS", in the existing first paragraph,
modified by Amendment 1, "safety sign" with "SAFETY SIGN" in three places, and in the existing
second paragraph, "safety sign" with "SAFETY SIGN".
Replace, in existing list item a), "safety sign" with "SAFETY SIGN" and "safety signs" with "SAFETY
SIGNS".
Replace, in existing list items b), c) and d), "safety sign" with "SAFETY SIGN".
Replace, in the existing third paragraph, "safety sign" with "SAFETY SIGN", and in NOTE 2,
replace "safety signs" with "SAFETY SIGNS".
Replace, in the existing fourth and fifth paragraphs, "safety signs" with "SAFETY SIGNS".
7.8.1 Colours of indicator lights
Add an asterisk (*) at the beginning of the subclause title.

– 14 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
Table 2 – Colours of indicator lights and their meaning for ME EQUIPMENT
Replace the existing table and its title with the following new table:
Table 2 – Colours and meanings of indicator lights
and alarm indicator lights for ME EQUIPMENT
a
Name On when Alarm indicator Accompanied by Operator
Indicator light
light sound requirement
b c
HAZARDOUS Red, not flashing – Avoidance of a
Warning –
SITUATION is to be HAZARDOUS
avoided which
SITUATION
could cause death
or serious injury
b
HAZARDOUS Yellow, not – – Avoidance of a
Caution
SITUATION is to be flashing HAZARDOUS
avoided SITUATION which
could cause minor
or moderate injury
or equipment
damage
Ready for use ME EQUIPMENT is Green – – –
ready for use
d d
HIGH PRIORITY Interruption of – Immediate action
Red, flashing Typically
ALARM CONDITION current workflow is to prevent injury
needed
d d
MEDIUM PRIORITY Re-planning of – Prompt action to
Yellow, flashing Typically
ALARM CONDITION current workflow is prevent injury
needed
d
LOW PRIORITY Planning of future – Yellow or cyan, Awareness for
Optional
d
ALARM CONDITION workflow is future action
not flashing
needed
Other Situations other Any colour other – – –
than that of red, than red, yellow,
yellow or green cyan or green
a
These indicator lights are INFORMATION SIGNALS and IEC 60601-1-8 requires that they be perceived as different
than visual ALARM SIGNALS.
b
Such warnings and cautions are frequently accompanied by a SAFETY SIGN.
c
Sound may be utilized, but IEC 60601-1-8 requires that it be perceived as different than auditory ALARM SIGNALS.
d
As specified in IEC 60601-1-8.

7.9.2.1 * General
Replace, in the existing fourth paragraph, "safety signs" with "SAFETY SIGNS".
7.9.3.1 * General
Replace, in the second dash of the existing second paragraph, modified by Amendment 1,
"safety signs" with "SAFETY SIGNS".
8.4.2 ACCESSIBLE PARTS and APPLIED PARTS
Renumber the existing NOTE as NOTE 1.
Add, after the final paragraph of existing list item c) modified by Amendment 1, the following
text:
© IEC 2020
If the ME EQUIPMENT has SIP/SOP connectors or separate power supply output connectors,
measure the voltage of all conductive ACCESSIBLE PARTS of the SIP/SOP connectors or power
output connectors to earth:
– Connect a resistor of 10 kΩ ± 500 Ω (8 W for measurements up to 280 V r.m.s.) between
the SIP/SOP-pin (or other output connector) to earth.
– Connect in parallel to the 10 kΩ resistor a peak voltmeter or an oscilloscope to measure
the voltage.
If the voltage measured above is less than or equal to 60 V d.c. or 42,4 V peak a.c., a
subsequent LEAKAGE CURRENT test is not necessary.
NOTE 2 A similar approach exists in IEC 60950-1:2005, 1.4.9.
NOTE 3 10 kΩ has been selected, because it is a value higher than the body impedance of the OPERATOR
(= 1 kΩ) and lower than the expected impedance of the insulation barrier (approximately 1 MΩ). Furthermore,
IEC 60950-1:2005, 1.4.9 used a 5 kΩ resistor and therefore using a 10 kΩ resistor provides greater safety.
If the voltage measurement above exceeds the specified levels, then the TOUCH CURRENT
from SIP/SOP connectors to earth and from any separate power supply output connectors to
earth shall be measured.
Measure the TOUCH CURRENT derived from the SUPPLY MAINS by applying the limits in 8.7.3 c)
from the connectors described above in:
– NORMAL CONDITION including open FUNCTIONAL EARTH CONDUCTOR (if applicable); and
– SINGLE FAULT CONDITION (respectively open neutral conductor; open PROTECTIVE EARTH
CONDUCTOR (if applicable)).
NOTE 4 If the SIP/SOP circuit is completely isolated from the floating (non-earth referenced) SECONDARY CIRCUIT
by an own insulation barrier of at least 1 MOOP based on MAINS VOLTAGE, i.e. a SEPARATION DEVICE according to
16.5, the measurement of the SIP/SOP connector to earth TOUCH CURRENT does not need to be conducted. In
such cases it is sufficient to evaluate the effectiveness of the SEPARATION DEVICE by measurement according to
8.7.4.7 c).
NOTE 5 For CLASS I ME EQUIPMENT with earth referenced SECONDARY CIRCUITS in NORMAL CONDITION, the
LEAKAGE CURRENT derived from the SUPPLY MAINS will be superimposed by the secondary voltage generated
current. However, the SUPPLY MAINS derived LEAKAGE CURRENT will usually be equal to the TOUCH CURRENT
measured on parts connected to the PROTECTIVE EARTH TERMINAL both in NORMAL CONDITION and in SINGLE FAULT
CONDITION (open neutral conductor; open PROTECTIVE EARTH CONDUCTOR). If in doubt, the measurement can
usually be done by setting the voltage meter to AC-measurement only or by using an oscilloscope or any other
equivalent method to assure that the secondary voltage will not influence the measurement result.
8.5.1.1 General
Replace the existing second paragraph with:
Each MEANS OF PROTECTION shall be categorized in relation to the ME EQUIPMENT part(s) which
it protects from exceeding permitted limits. It is a MEANS OF PATIENT PROTECTION if it protects
APPLIED PARTS or parts that are identified according to 4.6 as needing to be subject to the same
requirements as APPLIED PARTS. Otherwise the requirements for either MOPP or MOOP shall be
used as shown in Figure 40.
Replace the existing NOTE, modified by Amendment 1, with:
NOTE Coatings and other insulation that are intended as a MEANS OF PROTECTION and that comply with
IEC 60950-1:2005 or IEC 62368-1:2018 can be used as a MEANS OF OPERATOR PROTECTION but not automatically as
a MEANS OF PATIENT PROTECTION. For MEANS OF PATIENT PROTECTION, considerations can arise as a result of the RISK
.
MANAGEMENT PROCESS
Add, after the existing sixth paragraph, added by Amendment 1, the following new figure:

– 16 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
Figure 40 – Identification of MEANS OF PATIENT PROTECTION
and MEANS OF OPERATOR PROTECTION
8.5.1.2 * MEANS OF PATIENT PROTECTION (MOPP)
Add, after the existing second paragraph, the following NOTES:
NOTE 1 Barriers providing 2 MOOP with AIR CLEARANCE values according to Table 13 to Table 15 (inclusive) or
according to IEC 60950-1:2005, IEC 60950-1:2005/AMD1:2009 and IEC 60950-1:2005/AMD2:2013 meet the
requirements for 1 MOPP according to Table 12 for WORKING VOLTAGES up to 707 V d.c. / 500 V r.m.s. At higher
WORKING VOLTAGES, 2 MOOP does not necessarily provide 1 MOPP.
Barriers providing REINFORCED INSULATION (2 MOOP) with AIR CLEARANCE values according to IEC 62368-1:2018 for
WORKING VOLTAGES up to and including 354 V d.c. / 250 V r.m.s. meets the requirements for 1 MOPP according to
Table 12. At higher WORKING VOLTAGES, REINFORCED INSULATION (2 MOOP) does not necessarily provide 1 MOPP.
See also 8.5.1.3.
NOTE 2 Barriers providing REINFORCED INSULATION (2 MOOP) with CREEPAGE DISTANCES according to
IEC 62368-1:2018, Table 17 and Table 18 or IEC 60950-1:2005, IEC 60950-1:2005/AMD1:2009,
IEC 60950-1:2005/AMD2:2013, Table 2N meet the requirements for 1 MOPP according to Table 12.
Add after the existing fifth paragraph, added by Amendment 1, the following text:

© IEC 2020
NOTE 3 When fitting Y capacitors across barriers, the dielectric strength requirement is to be considered. For
example, for voltages in the range of 212 V peak to 354 V peak, two MEANS OF PATIENT PROTECTION are tested at
4 000 V a.c.; therefore, Y1 capacitors are used. Two Y2 capacitors in series would not withstand this voltage as they
are rated at 1 500 V a.c. each. For voltages below 212 V peak, two Y2 capacitors would suffice as the dielectric
strength requirement is 3 000 V a.c.
Opto-couplers complying with IEC 60747-5-5:2007, or a later edition, are considered equivalent
to the requirements of 8.8.2 and 8.9.3.
All of the following apply:
– AIR CLEARANCE at the outside of the opto-coupler;
– CREEPAGE DISTANCE at the outside of the opto-coupler; and
– dielectric strength across the opto-coupler.
NOTE 4 The factor of 1,6 on insulation test voltage is only used for thermal cycling tests (8.9.3), as also in other
safety standards (e.g. IEC 62368-1, IEC 60950-1). IEC 60747-5-5 applies different test methods. Because
compliance with IEC 60747-5-5 is regarded as equivalent to the thermal cycling test, the 1,6 factor is not required.
This is the same approach used in IEC 62368-1:2018, 5.4.4.4.
NOTE 5 Distance through insulation (0,4 mm) and thermal cycling testing are not required because compliance with
the component standards addresses the RISK of pin holes and thermal effects on the insulating compound.
8.5.1.3 MEANS OF OPERATOR PROTECTION (MOOP)
Replace the second dash of the existing first paragraph with:
– comply with the requirements of IEC 60950-1:2005, IEC 60950-1:2005/AMD1:2009 and
IEC 60950-1:2005/AMD2:2013 for INSULATION CO-ORDINATION; or
– comply with the requirements of IEC 62368-1:2018 for INSULATION CO-ORDINATION.
Replace the second dash of the existing second paragraph with:
– comply with the requirements of IEC 60950-1:2005, IEC 60950-1:2005/AMD1:2009 and
IEC 60950-1:2005/AMD2:2013 for INSULATION CO-ORDINATION; or
– comply with the requirements of IEC 62368-1:2018 for INSULATION CO-ORDINATION.
Replace the second dash of the existing third paragraph with:
– comply with the requirements and tests of IEC 60950-1:2005,
IEC 60950-1:2005/AMD1:2009 and IEC 60950-1:2005/AMD2:2013 for protective earthing;
or
– comply with the requirements of IEC 62368-1:2018 for protective earthing.
Add, after the existing fourth paragraph, added by Amendment 1, the following text:
Opto-couplers complying with IEC 60747-5-5:2007, or a later edition, are considered equivalent
to the requirements of 8.8.2 for distances through solid insulation and 8.9.3 for spaces filled by
insulating compound.
The following apply:
– AIR CLEARANCE at the outside of the opto-coupler;
– CREEPAGE DISTANCE at the outside of the opto-coupler; and
– dielectric strength across the opto-coupler.
NOTE 1 The factor of 1,6 on insulation test voltage is only used for thermal cycling tests (8.9.3), as also in other
safety standards (e.g. IEC 62368-1, IEC 60950-1). IEC 60747-5-5 applies different test methods. Because
compliance with IEC 60747-5-5 is regarded as equivalent to the thermal cycling test, the 1,6 factor is not required.
This is the same approach used in IEC 62368-1:2018, 5.4.4.4.
NOTE 2 Distance through insulation (0,4 mm) and thermal cycling testing are not required because compliance with
the component standards addresses the RISK of pin holes and thermal effects on the insulating compound.

– 18 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
Renumber the existing NOTE modified by Amendment 1 following the existing fifth paragraph,
as "NOTE 3".
Replace, in the first, second and fourth dashes of the existing sixth paragraph, the reference to
"IEC 60950-1" with "IEC 60950-1:2005, IEC 60950-1:2005/AMD1:2009 and
IEC 60950-1:2005/AMD2:2013 or IEC 62368-1:2018".
Delete the existing seventh paragraph.
8.5.2.2 * TYPE B APPLIED PARTS
Add the following sentence at the end of the existing second dash of the first paragraph:
In this case, the test in 8.7.4.7 d) does not apply.
8.5.2.3 * PATIENT LEADS or PATIENT cables
Replace, in the existing first dash of the first paragraph, modified by Amendment 1, "remote"
with "distal".
8.5.3 * MAXIMUM MAINS VOLTAGE
Replace, in the existing first dash, "unless this is" with "unless the highest RATED supply voltage
is", and replace "250 V" with "240 V".
Replace, in the existing third dash, "250 V" with "240 V".
8.5.4 * WORKING VOLTAGE
Add before the existing first dash, the following text and figure:
– For WORKING VOLTAGE measurement, all circuits shall be connected to earth with the
exception of floating parts providing at least one MEANS OF PROTECTION to earth in which
case the highest measured voltage on either side of the barrier is the WORKING VOLTAGE (see
Figure 41).
© IEC 2020
a)
For Case 1, the floating circuit is isolated from earth by 1 MOP based on the floating circuit voltage U . The
WORKING VOLTAGE (U ) of the mains barrier is the highest voltage of one side of the barrier, i.e. U or U whichever
w 1 2
is greater in magnitude.
b)
For Case 2, the floating circuit is not isolated by at least 1 MOP to earth based on the floating circuit voltage U .
For the measurement of the WORKING VOLTAGE (U ) of the mains barrier both sides have to be earthed to obtain
w
repeatable worst-case results.
Figure 41 – WORKING VOLTAGE measurement
8.5.5.1 * Defibrillation protection
Add, after the existing NOTE 2, modified by Amendment 1, the following text:
The differential-mode test shall not be performed on an APPLIED PART with multiple PATIENT
CONNECTIONS if, based on the INTENDED USE, the PATIENT CONNECTIONS are intended to be
completely within the body and in close proximity to each other where it can be assumed that
they will all be at the same voltage potential when the PATIENT is defibrillated.
8.5.5.2 Energy reduction test
Add, after the existing first paragraph, the following text:
If the INTENDED USE of one APPLIED PART with multiple PATIENT CONNECTIONS that are all within
close proximity to each other and completely within the body, these PATIENT CONNECTIONS are
treated as a single PATIENT CONNECTION.
8.6.1 * Applicability of requirements
Replace, in the existing paragraph, the reference to "IEC 60950-1" with "IEC 60950-1:2005,
IEC 60950-1:2005/AMD1:2009 and IEC 60950-1:2005/AMD2:2013 or IEC 62368-1:2018".
8.6.4 * Impedance and current-carrying capability
Replace the sixth paragraph of existing list item a), modified by Amendment 1, with:
Testing shall be carried out using a DETACHABLE POWER SUPPLY CORD as provided or specified
(length and cross-sectional area) by the MANUFACTURER.

– 20 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
Add, after the existing ninth paragraph of list item a), modified by Amendment 1, the following
text:
The highest RATED current is the RATED current of the over-current protection in the
ME EQUIPMENT, when present, for all circuits located behind the over-current protection. From
the SUPPLY MAINS to the over-current protection in the ME EQUIPMENT, the highest RATED current
RATED current of the over-current protection device in the building installation.
is the
NOTE When protective earth is relied on as a MEANS OF PROTECTION, the test current is determined based on the
location where a fault could occur. If the prospective fault is in the mains supply circuit prior to the over-current
protection included in the ME EQUIPMENT, the test current for that part of the protective earth circuit is based on the
rating of the external over-current protection included in the building infrastructure or specified in the ACCOMPANYING
DOCUMENTS (1,5 times the interrupt rating of the external over-current protection). If the prospective fault is in the
mains supply circuit after the over-current protection included in the ME EQUIPMENT, the test current is based on the
rating of the over-current protection included in the ME EQUIPMENT (1,5 times the interrupt rating of the ME EQUIPMENT
over-current protection). In either case, the minimum test current is 25 A.
8.7.3 *
...