IEC TS 60601-4-2:2024
(Main)Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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.
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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
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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 syste
...
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