IEC TS 60601-4-2:2024

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

IEC TS 60601-4-2:2024 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM, respectively.
The object of this document is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES.
IEC TS 60601-4-2:2024 cancels and replaces the first edition of IEC TR 60601-4-2 published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TR 60601-4-2:2016:
a) aligned with IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
b) updated references,
c) changed conducted disturbance cable length exclusion (Table 6) from 3 m to 1 m and added a citation of IEC 61000-4-6:2013, Annex B.

General Information

• Status: Published
• Publication Date: 19-Mar-2024
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.100.20 - Immunity
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 20-Mar-2024
• Completion Date: 15-Mar-2024

Relations

• Revises: IEC TR 60601-4-2:2016 - Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
• Effective Date: 27-Oct-2023

Overview

IEC TS 60601-4-2:2024 - "Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems" is a Technical Specification from IEC that provides guidance on assessing the performance of ME EQUIPMENT and ME SYSTEMS in the presence of electromagnetic (EM) disturbances. It replaces IEC TR 60601-4-2:2016 and aligns with relevant parts of the IEC 60601 series to help manufacturers, test laboratories and regulators interpret immunity requirements and demonstrate safe operation in real-world EM environments.

Key topics and requirements

• Scope and purpose: Guidance for evaluating medical electrical equipment/systems (ME EQUIPMENT / ME SYSTEM) under EM disturbances and documenting test plans and reports.
• Alignment with IEC 60601-1-2: Aligned with IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 for consistent immunity assessment and performance criteria.
• Updated normative references and mappings (Annex F) to help integrate this TS into conformity workflows.
• Changes to conducted disturbance exclusions: The conducted disturbance cable length exclusion in Table 6 was revised from 3 m to 1 m, affecting which cables/ports are subject to testing.
• ESD and connector testing: Expanded guidance on electrostatic discharge (ESD) application to connectors, exclusions and parts to be tested; citation added to IEC 61000-4-6:2013 Annex B for conducted RF immunity considerations.
• Test planning and documentation: Recommended minimum test plan and required test-report contents (tables and annexes provide templates and examples).
• Ports, patient-coupling and simulation: Definitions and recommendations for enclosure ports, power ports (AC/DC), patient-coupling ports, and patient physiological simulation during immunity testing.
• Performance criteria and environments: Guidance on establishing immunity performance criteria, special environments, and mitigations (Annexes C and D).

Applications - who uses this standard

• Medical device manufacturers - to design for EMC robustness and prepare conformity evidence.
• EMC test laboratories - to interpret test scope, connector/port testing and reporting requirements.
• Regulatory and conformity assessors - to evaluate immunity performance and documentation against IEC 60601 series expectations.
• Clinical engineers and system integrators - for system-level EMC assessments of permanently installed or large ME SYSTEMS.
• Risk managers - to define performance criteria and mitigations in specific EM environments.

Related standards

• IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 - general EMC requirements for medical electrical equipment.
• IEC 61000-4-6:2013 - conducted RF immunity (referenced, Annex B cited).
• Other parts of the IEC 60601 series covering safety and performance for medical electrical equipment.

Keywords: IEC TS 60601-4-2:2024, electromagnetic immunity, medical electrical equipment, ME SYSTEM, EMC testing, ESD connectors, IEC 60601-1-2, IEC 61000-4-6.

Standards Content (Sample)

IEC TS 60601-4-2 ®
Edition 1.0 2024-03
TECHNICAL
SPECIFICATION
Medical electrical equipment –
Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance
of medical electrical equipment and medical electrical systems

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 Secretariat Tel.: [phone]
3, rue de Varembé [e-mail]
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 IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews, graphical symbols and the glossary.
committee, …). It also gives information on projects, replaced With a subscription you will always have access to up to date
and withdrawn publications. content tailored to your needs.

IEC Just Published - webstore.iec.ch/justpublished
Electropedia - www.electropedia.org
Stay up to date on all new IEC publications. Just Published
The world's leading online dictionary on electrotechnology,
details all new publications released. Available online and once
containing more than 22 500 terminological entries in English
a month by email.
and French, with equivalent terms in 25 additional languages.

Also known as the International Electrotechnical Vocabulary
IEC Customer Service Centre - webstore.iec.ch/csc
(IEV) online.
If you wish to give us your feedback on this publication or need

further assistance, please contact the Customer Service
Centre: [e-mail].
IEC TS 60601-4-2 ®
Edition 1.0 2024-03
TECHNICAL
SPECIFICATION
Medical electrical equipment –

Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance

of medical electrical equipment and medical electrical systems

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01; 33.100.20 ISBN 978-2-8322-8289-2

– 2 – IEC TS 60601-4-2:2024 © IEC 2024
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
0.1 * General . 8
0.2 Purpose of this document . 8
0.3 How to use this document . 8
0.4 IMMUNITY TEST LEVELS . 9
1 Scope . 10
2 Normative references . 10
3 Terms and definitions . 12
4 General recommendations . 15
4.1 Concurrent and sequential testing . 15
4.2 General test conditions . 15
4.2.1 Configurations . 15
4.2.2 Artificial hand . 16
4.2.3 Power input voltages and frequencies . 17
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents . 17
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts for which the
connector testing exemption specified in 8.13.2 d) is used . 17
5.2 ACCOMPANYING DOCUMENTS . 17
5.2.1 General . 17
5.2.2 Instructions for use . 17
5.2.3 Requirements applicable to ME EQUIPMENT and ME SYSTEMS for which
the connector testing exemption specified in 8.13.2 d) is used . 17
5.2.4 * Technical description . 18
6 Documentation of the tests . 18
6.1 Test plan . 18
6.2 Test report . 19
7 * EMISSIONS . 19
8 IMMUNITY recommendations . 19
8.1 General . 19
8.2 PATIENT physiological simulation . 20
8.3 Termination of PATIENT-COUPLED parts . 21
8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 21
8.5 Subsystems . 21
8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS . 21
8.7 Operating modes . 22
8.8 Non-ME EQUIPMENT . 22
8.9 * Environments of INTENDED USE . 22
8.10 * Performance criteria . 23
8.11 * IMMUNITY TEST LEVELS . 23
8.12 * IMMUNITY to proximity fields from RF wireless communications equipment . 30
8.13 * ESD testing of connectors . 31
8.13.1 Application of ESD to connectors . 31
8.13.2 Exclusions . 32
8.14 Test report . 32
Annex A (informative) General guidance and rationale . 34

Annex B (informative) Guide to labelling recommendations . 40
B.1 ACCOMPANYING DOCUMENTS, instructions for use . 40
B.2 ACCOMPANYING DOCUMENTS, technical description . 40
Annex C (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL
ENVIRONMENTS . 41
C.1 General . 41
C.2 EM DISTURBANCE level determination . 42
C.3 Assessment of EM DISTURBANCE sources . 42
C.4 Test methods . 42
C.5 Test plan . 42
C.6 Examples of mitigations and special conditions . 43
Annex D (informative) Identification of specific IMMUNITY performance criteria . 44
D.1 General . 44
D.2 IMMUNITY performance criteria principles . 44
D.2.1 General . 44
D.2.2 IMMUNITY performance criteria for non-ME EQUIPMENT used in an
ME SYSTEM . 44
D.2.3 IMMUNITY performance criteria determination . 44
D.3 IMMUNITY performance criteria examples . 44
D.3.1 General examples . 44
D.3.2 Example of immunity performance criteria for a radiological table
system . 46
D.3.3 Example of immunity performance criteria for ultrasonic diagnostic
equipment. 46
Annex E (informative) Performance criteria specified by IEC 61000-6-x generic EMC
standards . 48
Annex F (informative) Mapping between this document and the elements of
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 . 49
Bibliography . 55
Index of defined terms used in this document . 57

Figure 1 – RC element of the artificial hand . 16
Figure 2 – * PORTS of ME EQUIPMENT and ME SYSTEMS . 20
Figure 3 – Examples of locations within EM ENVIRONMENTS . 25

Table 1 – Recommended minimum test plan . 18
Table 2 – * ENCLOSURE PORT . 26
Table 3 – * Input AC power PORT . 27
Table 4 – Input DC power PORT . 28
Table 5 – * PATIENT COUPLING PORT . 29
Table 6 – SIP/SOP PORT . 29
Table 7 – Test specifications for enclosure port immunity to RF wireless
communications equipment . 30
Table 8 – Parts of connectors to be tested for ESD, based on the connector shell and
cover material . 31
Table 9 – * Testing of connectors and pins while connected and disconnected . 31
Table 10 – Test report minimum contents . 32

– 4 – IEC TS 60601-4-2:2024 © IEC 2024
Table A.1 – Assumptions used in determining IMMUNITY TEST LEVELS specified in
Table 7 . 38
Table B.1 – ACCOMPANYING DOCUMENTS, instructions for use . 40
Table B.2 – ACCOMPANYING DOCUMENTS, technical description . 40
Table C.1 – Examples of adjusted IMMUNITY TEST LEVELS due to mitigations or special
conditions . 43
Table D.1 – Example of IMMUNITY performance criteria for a radiological table and
gantry system . 46
Table D.2 – Example of IMMUNITY performance criteria for ULTRASONIC DIAGNOSTIC
EQUIPMENT . 47
Table F.1 – Mapping between the elements of this document and IEC 60601-1-2:2014
and IEC 60601-1-2:2014/AMD1:2020 . 49

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 4-2: Guidance and interpretation – Electromagnetic immunity:
performance of medical electrical equipment
and medical electrical systems

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC 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
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC TS 60601-4-2 has been prepared by subcommittee 62A: Common aspects of medical
equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems. It is a Technical Specification.
This first edition cancels and replaces the first edition of IEC TR 60601-4-2 published in 2016.
This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to
IEC TR 60601-4-2:2016:
a) aligned with IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
b) updated references,
– 6 – IEC TS 60601-4-2:2024 © IEC 2024
c) changed conducted disturbance cable length exclusion (Table 6) from 3 m to 1 m and added
a citation of IEC 61000-4-6:2013, Annex B.
The text of this Technical Specification is based on the following documents:
Draft Report on voting
62A/1532/DTS 62A/1560/RVDTS
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Technical Specification is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– recommendations and definitions: roman type.
– test instructions: 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 THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 1 includes 1.1, 1.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 1.1, 1.2 and 1.3.1 are all
subclauses of Clause 1).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document; however, we chose to use it in this document only as described in 0.3;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IMPORTANT – The "colour inside" logo on the cover page of this document 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.

– 8 – IEC TS 60601-4-2:2024 © IEC 2024
INTRODUCTION
0.1 * General
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS are used in the practice of
medicine because they provide functions that are associated with the INTENDED USE. If MEDICAL
ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM does not provide these functions
because of a lack of IMMUNITY to EM DISTURBANCES, that are expected to occur in the
INTENDED USE, this can interfere with the practice of medicine. This document
environment(s) of
provides guidance for IMMUNITY of functions of INTENDED USE that are not related to BASIC SAFETY
or ESSENTIAL PERFORMANCE.
Examples of functions that might not be BASIC SAFETY or ESSENTIAL PERFORMANCE but that might
be INTENDED USE include the following:
– the ability to print an ultrasound image remotely;
PATIENT weight;
– the ability of a scale to accurately measure
– accuracy of X-RAY TUBE VOLTAGE in X-ray equipment for radiography and radioscopy, e.g.
the error is less than 5 %.
See Annex A for more information.
In general, the IMMUNITY TEST LEVELS in IEC 60601-1-2 are based on reasonably foreseeable
maximum levels of EM DISTURBANCES. In this document, IMMUNITY TEST LEVELS for performance
are based on typical levels of EM DISTURBANCES. Rationale concerning test methodology can be
found in Annex A of this document and in Annex A of IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020.
NOTE In general, typical IMMUNITY TEST LEVELS are equal to or lower than reasonably foreseeable maximum levels.
0.2 Purpose of this document
The purpose of this document is to provide a consistent method for evaluating the ability of
MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM to perform without degradation
of performance in the presence of typical EM DISTURBANCES.
0.3 How to use this document
This document can be used in conjunction with IEC 60601-1-2 and testing for conformity to both
documents can be done at the same time. This allows IMMUNITY testing of BASIC SAFETY,
ESSENTIAL PERFORMANCE and performance of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL
ELECTRICAL SYSTEM during one test, concurrently or sequentially. The main difference is the use
of performance criteria instead of pass/fail criteria, and differences can also include modes and
configurations. For BASIC SAFETY and ESSENTIAL PERFORMANCE, the pass/fail criteria are
determined as specified by IEC 60601-1-2. For performance, the criteria are determined by the
specifications, instructions and information provided by the MANUFACTURER.
This document uses "recommend" and "should" in place of “shall" in most cases. "Shall" is used
where an action is required by other standards or something needs to be done in a prescribed
way in order to be effective. Also, this document has "normative" references. They are
"normative" because if you choose to follow the recommendations of this document, they are
indispensable for that use. An example of this would be testing for radiated RF IMMUNITY. The
test methods of IEC 61000-4-3 would be indispensable for this testing.

0.4 IMMUNITY TEST LEVELS
The IMMUNITY TEST LEVELS specified in this document are typical for the locations of INTENDED
USE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. However, Annex C
provides a method for modifying the specified typical IMMUNITY TEST LEVELS for performance if
necessary or for particular environments (e.g. SPECIAL ENVIRONMENTS) for which this document
does not specify IMMUNITY TEST LEVELS.

– 10 – IEC TS 60601-4-2:2024 © IEC 2024
MEDICAL ELECTRICAL EQUIPMENT –

Part 4-2: Guidance and interpretation – Electromagnetic immunity:
performance of medical electrical equipment
and medical electrical systems

1 Scope
This document applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL
ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL
EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM,
respectively.
The object of this document is to provide guidance on the assessment of the performance of
ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 in normative requirements determines the extent (in
whole or in part) to which they apply.
IEC 60417:2002, Graphical symbols for use on equipment, available from: http://www.graphical-
symbols.info/equipment
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: EM disturbances – Requirements and
tests
IEC 60601-1-2:2014/AMD1:2020
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
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-11:2015/AMD1:2020
IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in the emergency medical services
environment
IEC 60601-1-12:2014/AMD1:2020
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) – Part 4-2: Testing and
measurement techniques – Electrostatic discharge immunity test
IEC 61000-4-3:2006 , Electromagnetic compatibility (EMC) – Part 4-3: Testing and
measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-3:2006/AMD1:2007
IEC 61000-4-3:2006/AMD2:2010
IEC 61000-4-4:2012, Electromagnetic compatibility (EMC) – Part 4-4: Testing and
measurement techniques – Electrical fast transient/burst immunity test
IEC 61000-4-5:2014, Electromagnetic compatibility (EMC) – Part 4-5: Testing and
measurement techniques – Surge immunity test
IEC 61000-4-5:2014/AMD1:2017
, Electromagnetic compatibility (EMC) – Part 4-6: Testing and
IEC 61000-4-6:2013
measurement techniques – Immunity to conducted disturbances, induced by radio-frequency
fields
IEC 61000-4-8:2009, Electromagnetic compatibility (EMC) – Part 4-8: Testing and
measurement techniques – Power frequency magnetic field immunity test
IEC 61000-4-11:2004 , Electromagnetic compatibility (EMC) – Part 4-11: Testing and
measurement techniques – Voltage dips, short interruptions and voltage variations immunity
tests
IEC 61000-4-11:2004/AMD1:2017
CISPR 16-1-2:2014, Specification for radio disturbance and immunity measuring apparatus and
methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Coupling devices
for conducted disturbance measurements
CISPR 16-1-2:2014/AMD1:2017
ISO 7637-2:2011, Road vehicles – Electrical disturbances from conduction and coupling –
Part 2: Electrical transient conduction along supply lines only
___________
This publication was withdrawn.
This publication was withdrawn and replaced with IEC 61000-4-6:2023.
This publication was withdrawn.

– 12 – IEC TS 60601-4-2:2024 © IEC 2024
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-11:2015,
IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014, IEC 60601-1-12:2014/AMD1:2020
and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE 1 Where the terms "voltage" and "current" are used in this document, they mean the RMS values of an
alternating, direct or composite voltage or current unless stated otherwise.
NOTE 2 The term "electrical equipment" is used to mean ME EQUIPMENT or other electrical equipment. This
document also uses the term "equipment" to mean ME EQUIPMENT or other electrical or non-electrical equipment in
the context of an ME SYSTEM.
NOTE 3 The dictionary definition of "performance" applies.
NOTE 4 An index of defined terms is found at the end of the document.
3.1
ACCESSIBLE PART
part of electrical equipment other than an APPLIED PART that can be touched by means of the
standard test finger
Note 1 to entry: See also 5.9.2.1 of IEC 60601-1:2005.
[SOURCE: IEC 60601-1:2005, 3,2, modified – the original NOTE has been modified to add a
reference to IEC 60601-1:2005.]
3.2
APPLIED PART
part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the
PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function
Note 1 to entry: See Figure 3, Figure 4 and Figure A.1 to Figure A.7 (inclusive) of IEC 60601-1:2005.
[SOURCE: IEC 60601-1:2005, 3.8, modified – Note 1 has been modified to add a reference to
IEC 60601-1:2005 and Note 2 and Note 3 have been deleted.]
3.3
ELECTROMAGNETIC DISTURBANCE
EM DISTURBANCE
any electromagnetic phenomenon that could degrade the performance of a device, equipment
or system
Note 1 to entry: An EM DISTURBANCE can be ELECTROMAGNETIC NOISE, an unwanted signal or a change in the
propagation medium itself.
[SOURCE: IEC 60601-1-2:2014, 3.3]
3.4
EMISSION
ELECTROMAGNETIC EMISSION
the phenomenon by which electromagnetic energy emanates from a source
[SOURCE: IEC 60601-1-2:2014, 3.4]

3.5
ELECTROMAGNETIC ENVIRONMENT
EM ENVIRONMENT
the totality of electromagnetic phenomena existing at a given location
Note 1 to entry: In general, the EM ENVIRONMENT is time dependent and its description might need a statistical
approach.
[SOURCE: IEC 60601-1-2:2014, 3.5]
3.6
ELECTROSTATIC DISCHARGE
ESD
a transfer of electric charge between bodies of different electrostatic potential in proximity or
through direct contact
[SOURCE: IEC 60601-1-2:2014, 3.6]
3.7
ENCLOSURE PORT
physical boundary of the ME EQUIPMENT or ME SYSTEM that electromagnetic fields can radiate
through or impinge on
[SOURCE: IEC 60601-1-2:2014, 3.7, modified – Note 1 to entry has been deleted.]
3.8
IMMUNITY
the ability of ME EQUIPMENT or an ME SYSTEM to perform without degradation in the presence of
an EM DISTURBANCE
[SOURCE: IEC 60601-1-2:2014, 3.8]
3.9
IMMUNITY TEST LEVEL
level of a test signal used to simulate an EM DISTURBANCE when performing an IMMUNITY test
[SOURCE: IEC 60601-1-2:2014, 3.9]
3.10
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 to entry: 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, service, transport, etc. as well.
[SOURCE: IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.44, modified ─ Existing
Note 1 to entry deleted and Note 2 to entry converted to Note 1 to entry.]
3.11
LARGE ME EQUIPMENT
ME EQUIPMENT that cannot fit within a 2 m × 2 m × 2,5 m volume, excluding cables
[SOURCE: IEC 60601-1-2:2014, 3.12]

– 14 – IEC TS 60601-4-2:2024 © IEC 2024
3.12
LARGE ME SYSTEM
ME SYSTEM that cannot fit within a 2 m × 2 m × 2,5 m volume, excluding cables; this includes
distributed ME SYSTEMS
[SOURCE: IEC 60601-1-2:2014, 3.13]
3.13
LOW VOLTAGE
line-to-line or line-to-neutral voltage that is less than or equal to 1 000 V AC or 1 500 V DC
[SOURCE: IEC 60601-1-2:2014, 3.14]
3.14
PATIENT-COUPLED
term referring to the presence of a path for the transfer of electromagnetic energy to or from
the PATIENT, whether intended or unintended
Note 1 to entry: Examples of types of coupling include conductive, capacitive, inductive and optical.
[SOURCE: IEC 60601-1-2:2014, 3.15]
3.15
PATIENT COUPLING POINT
a sensing or treatment point of ME EQUIPMENT that is necessary to achieve the INTENDED USE of
the ME EQUIPMENT or an ME SYSTEM and that provides a path for transfer of electromagnetic
energy to or from the PATIENT, whether intended or unintended
Note 1 to entry: Examples of types of coupling include conductive, capacitive, inductive and optical.
[SOURCE: IEC 60601-1-2:2014, 3.16]
3.16
PORT
access to a device or network where electromagnetic energy or signals can be supplied or
received or where the device or network variables can be observed or measured
Note 1 to entry: Examples of PORTS include terminal pairs, PATIENT cables (PATIENT CONNECTIONS), SIGNAL
INPUT/OUTPUT PARTS such as data PORTS and USB connections, battery charger connections, and the ENCLOSURE
itself (i.e. ENCLOSURE PORT).
[SOURCE: IEC 60601-1-2:2014, 3.17]
3.17
PUBLIC MAINS NETWORK
LOW VOLTAGE electricity power lines to which all categories of consumers have access
[SOURCE: IEC 60601-1-2:2014, 3.18]
3.18
RADIO FREQUENCY
RF
a frequency in the portion of the electromagnetic spectrum that is between the audio-frequency
portion and the infrared portion; frequency useful for radio transmission
[SOURCE: IEC 60601-1-2:2014, 3.19]

3.19
SIGNAL INPUT/OUTPUT PART
SIP/SOP
part of ME EQUIPMENT, not being an APPLIED PART, intended to deliver or receive signals to or
from other electrical equipment, for example, for display, recording or data processing
[SOURCE: IEC 60601-1:2005, 3.115]
3.20
SPECIAL ENVIRONMENT
EM ENVIRONMENT with electromagnetic characteristics different from those specified in this
document in Table 2 through Table 6 or that requires IMMUNITY TEST LEVELS or test methods that
are different from those specified for the professional healthcare facility environment and the
HOME HEALTHCARE ENVIRONMENT
Note 1 to entry: The definition also implies the locations where SPECIAL ENVIRONMENTS are found.
Note 2 to entry: For ME EQUIPMENT and ME SYSTEMS intended for use in SPECIAL ENVIRONMENTS, special IMMUNITY
TEST LEVELS can be applicable.
[SOURCE: IEC 60601-1-2:2014, 3.20, modified – references to the source document have been
changed to refer to this document, and Notes 1 and 2 to entry have been added.]
3.21
TRANSIENT
phenomenon or quantity which varies between two consecutive steady states during a time
interval short compared with the timescale of interest
[SOURCE: IEC 60050-161:2019 [1] , 161-02-01.]
4 General recommendations
4.1 Concurrent and sequential testing
MMUNITY testing according to this document can be performed concurrently or sequentially with
I
the IMMUNITY testing specified in IEC 60601-1-2.
If the IMMUNITY performance criteria determined according to this document are met at the
IMMUNITY TEST LEVELS specified in IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
Clause 8, no further testing is needed to demonstrate conformity to the recommendations of
this document.
4.2 General test conditions
4.2.1 Configurations
Best practice is that ME EQUIPMENT and ME SYSTEMS are tested in representative configurations
and modes consistent with INTENDED USE.
These configurations could include:
– attachment of cables to all PORTS as necessary to achieve the INTENDED USE (including
SIP/SOPs and, if applicable, the POTENTIAL EQUALIZATION CONDUCTOR);
– attachment of all tubing and filling of all fluid containers;
___________
Numbers in square brackets refer to the Bibliography.

– 16 – IEC TS 60601-4-2:2024 © IEC 2024
– termination of the cables with the intended equipment, subsystem simulators as specified
in 8.5, PATIENT physiological simulators as specified in 8.2 or artificial hands as specified in
4.2.2;
– earthing on the ENCLOSURE PORT, if applicable, including connections to the terminal for the
connection of a POTENTIAL EQUALIZATION CONDUCTOR;
– use of cables and connectors that meet the specifications of the ME EQUIPMENT or ME SYSTEM
MANUFACTURER.
If special hardware or software is needed to be used with the ME EQUIPMENT or ME SYSTEM while
performing the tests specified in Clause 8, then this shall be documented in the test plan and
test report.
NOTE If the configurations used in IEC 60601-1-2 testing meet the recommendations of this subclause, this can
facilitate concurrent or sequential testing.
4.2.2 Artificial hand
Where an artificial hand is required by this document, it shall be connected as follows:
– For PATIENT COUPLING POINTS that do not have a conductive contact, the PATIENT COUPLING
POINT is terminated with the artificial hand and (series) RC element shown in Figure 11a of
CISPR 16-1-2 (see Figure 1). The metal foil of the artificial hand is sized and placed to
simulate the approximate area and location of PATIENT coupling when the ME EQUIPMENT or
ME SYSTEM is providing its INTENDED USE. The metal foil of the artificial hand is connected to
terminal M of the RC element and the other terminal of the RC element is connected to the
ground reference plane.
– For PATIENT COUPLING POINTS that have conductive contact to the PATIENT (PATIENT
CONNECTION), terminal M of the RC element is connected directly to the PATIENT COUPLING
POINT, and the other terminal of the RC element is connected to the ground reference plane.
If normal operation of the ME EQUIPMENT or ME SYSTEM cannot be verified with terminal M
connected to the PATIENT COUPLING POINT, an insulating material with a maximum thickness
of 5 mm can be applied between the metal foil of the artificial hand and the PATIENT COUPLING
POINT. In this case, the metal foil of the artificial hand is to be sized and placed to simulate
the approximate area and location of PATIENT coupling when the ME EQUIPMENT or ME SYSTEM
is providing its INTENDED USE, and terminal M of the RC element shall be connected to the
metal foil but not to the PATIENT COUPLING POINT. The other terminal of the RC element is
connected to the ground reference plane in all cases.
– For ME EQUIPMENT and ME SYSTEMS that have multiple PATIENT COUPLING POINTS intended to
be connected to a single PATIENT, each PATIENT COUPLING POINT and each PATIENT-COUPLED
part shall have an artificial hand applied as specified above. The artificial hands are
connected to a single common connection and this common connection is connected to
terminal M of the RC element, as specified in 8.3 of CISPR 16-1-2:2014. For ME EQUIPMENT
and ME SYSTEMS intended to be connected to multiple PATIENTS, artificial hands shall be
applied as specified above and a separate common connection and RC element shall be
used for each PATIENT for which the capacitive coupling effect and RF impedance shall be
simulated. The other terminal of each RC element is connected to the ground reference
plane in all cases.
Figure 1 – RC element of the artificial hand

4.2.3 Power input voltages and frequencies
For all tests except for the IEC 61000-4-11 test, the test may be performed at any one power
input voltage within the ME EQUIPMENT or ME SYSTEM RATED voltage and any one RATED power
frequency. Unless otherwise specified in this document, if the ME EQUIPMENT or ME SYSTEM is
tested at one power input voltage and one power input frequency, it is not necessary to re-test
at additional voltages or frequencies.
The IEC 61000-4-11 tests are performed at the minimum RATED power input voltage and any
one RATED power input frequency. ME EQUIPMENT and ME SYSTEMS with power input voltage
selection by transformer taps should be tested according to IEC 61000-4-11 at only one tap
setting.
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents
5.1 Marking on the outside
...