IEC TR 60601-4-2:2016

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
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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) . 38
Table B.1 – ACCOMPANYING DOCUMENTS, instructions for use .
...