IEC 60601-2-37:2024

IEC 60601-2-37 ®
Edition 3.0 2024-07
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment
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IEC 60601-2-37 ®
Edition 3.0 2024-07
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55; 17.140.50 ISBN 978-2-8322-9372-0

– 2 – IEC 60601-2-37:2024 RLV © IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 17
201.5 General requirements for testing ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 23
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 30
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 32
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 32
201.15 Construction of ME EQUIPMENT . 32
201.16 ME SYSTEMS . 32
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 33
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment
(EMS) . 36
Annexes . 37
Annex AA (informative) Particular guidance and rationale . 38
Annex BB (informative) Guidance in classification according to CISPR 11 . 47
Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR . 48
Annex DD (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES . 52
Annex EE (informative) Acoustic output table intended for third parties . 55
Bibliography . 58
Index of defined terms . 62

Figure AA.1 – Method a) for an external probe . 41
Figure AA.2 – Method b) for an external probe . 42
Figure AA.3 – Method b) for an external probe . 42
Figure DD.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers . 54

Table 201.101 – List of symbols . 16
Table 201.102 – Distributed essential performance requirements . 18

Table 201.103 – Acoustic output reporting table . 22
Table 201.104 – Overview of the tests noted under 201.11.1.3 . 29
Table CC.1 – Relative importance of maintaining low exposure indices in various
scanning situations . 50
Table DD.1 – Acoustic and thermal properties of tissues and materials . 52
Table DD.2 – Weight % pure components . 53
Table EE.1 – Example of acoustic output table for third parties . 56

– 4 – IEC 60601-2-37:2024 RLV © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-37: Particular requirements for the basic safety
and essential performance of ultrasonic medical
diagnostic and monitoring equipment

FOREWORD
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition IEC 60601-2-37:2007+AMD1:2015 CSV. A vertical bar
appears in the margin wherever a change has been made. Additions are in green text,
deletions are in strikethrough red text.

IEC 60601-2-37 has been prepared by subcommittee 62B: Medical imaging equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
This third edition cancels and replaces the second edition published in 2007 and
Amendment 1:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) technical and editorial changes resulting from the amended general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
its collateral standards IEC 60601-1-xx,
b) technical and editorial changes as a result of maintenance to normative references;
c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics
standards. In particular, Clause 201.11 about protection against excessive temperatures
and other hazards has been fully revised.
The text of this International Standard is based on the following documents:
Draft Report on voting
62B/1318/CDV 62B/1348/RVC
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 International Standard 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 pr
...