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

IEC TR 60601-4-2:2016(E) applies to the performance of medical electrical equipment or a medical electrical system in the presence of electromagnetic disturbances.

General Information

• Status: Replaced
• Publication Date: 12-May-2016
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 29.060.10 - Wires
• ICS: 33.100.20 - Immunity
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems

Relations

• Revised: 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
• Effective Date: 27-Oct-2023

Standards Content (Sample)

IEC TR 60601-4-2 ®
Edition 1.0 2016-05
TECHNICAL
REPORT
colour
inside
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 Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]

CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

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IEC TR 60601-4-2 ®
Edition 1.0 2016-05
TECHNICAL
REPORT
colour
inside
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 978-2-8322-3414-3

– 2 – IEC TR 60601-4-2:2016 © IEC 2016

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 and object . 10

1.1 Scope . 10
1.2 Object . 10
2 Normative references. 10
3 Terms and definitions . 11
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 . 15
4.2.3 Power input voltages and frequencies . 16
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 c) 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 c) is used . 17
5.2.4 * Technical description . 17
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

9 Test report. 33

Annex A (informative) General guidance and rationale . 35

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 . 49
Bibliography . 54
Index of defined terms used in this technical report . 56

Figure 1 – RC element of the artificial hand . 16
Figure 2 – * PORTS of ME EQUIPMENT and ME SYSTEMS . 20

Figure 3 – Examples of environments (locations) of INTENDED USE . 25

Table 1 – Recommended minimum test plan (1 of 2) . 18
Table 2 – * ENCLOSURE PORT . 26
Table 3 – * Input AC power PORT (1 of 2) . 26
Table 4 – Input DC power PORT . 28
Table 5 – * PATIENT COUPLING PORT . 29
Table 6 – SIGNAL INPUT/OUTPUT PARTS PORT . 30
Table 7 – Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment . 31
Table 8 – Parts of connectors to be tested for ESD, based on the connector shell and
cover material . 32
Table 9 – * Testing of connectors and pins while connected and disconnected . 32

– 4 – IEC TR 60601-4-2:2016 © IEC 2016

Table 10 – Test report minimum contents (1 of 2) . 33

Table A.1 – Assumptions used in determining IMMUNITY TEST LEVELS specified in

Table 7 (1 of 2) .
...

IEC TR 60601-4-2 ®
Edition 1.0 2016-05
TECHNICAL
REPORT
colour
inside
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 Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: [e-mail].
IEC TR 60601-4-2 ®
Edition 1.0 2016-05
TECHNICAL
REPORT
colour
inside
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 978-2-8322-3414-3

– 2 – IEC TR 60601-4-2:2016 © IEC 2016
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 and object . 10
1.1 Scope . 10
1.2 Object . 10
2 Normative references. 10
3 Terms and definitions . 11
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 . 15
4.2.3 Power input voltages and frequencies . 16
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 c) 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 c) is used . 17
5.2.4 * Technical description . 17
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

9 Test report. 33
Annex A (informative) General guidance and rationale . 35
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 . 49
Bibliography . 54
Index of defined terms used in this technical report . 56

Figure 1 – RC element of the artificial hand . 16
Figure 2 – * PORTS of ME EQUIPMENT and ME SYSTEMS . 20
Figure 3 – Examples of environments (locations) of INTENDED USE . 25

Table 1 – Recommended minimum test plan (1 of 2) . 18
Table 2 – * ENCLOSURE PORT . 26
Table 3 – * Input AC power PORT (1 of 2) . 26
Table 4 – Input DC power PORT . 28
Table 5 – * PATIENT COUPLING PORT . 29
Table 6 – SIGNAL INPUT/OUTPUT PARTS PORT . 30
Table 7 – Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment . 31
Table 8 – Parts of connectors to be tested for ESD, based on the connector shell and
cover material . 32
Table 9 – * Testing of connectors and pins while connected and disconnected . 32

– 4 – IEC TR 60601-4-2:2016 © IEC 2016
Table 10 – Test report minimum contents (1 of 2) . 33
Table A.1 – Assumptions used in determining IMMUNITY TEST LEVELS specified in
Table 7 (1 of 2) . 38
Table B.1 – ACCOMPANYING DOCUMENTS, instructions for use .
...