IEC 60601-2-37:2024

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

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 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.

Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons

L'IEC 60601-2-37:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE DIAGNOSTIC A ULTRASONS comme cela est défini en 201.3.217, désignés ci-après sous le terme APPAREILS EM. Si un article ou un paragraphe est destiné spécifiquement à être applicable uniquement aux APPAREILS EM, ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue de l'APPAREIL EM ou du SYSTEME EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception du 201.7.2.13. Le présent document ne couvre pas les appareils thérapeutiques à ultrasons. Les appareils utilisés pour réaliser l'imagerie ou le diagnostic de structures du corps par ultrasons, en association avec une autre procédure médicale, sont couverts. L'IEC 60601-2-37:2024 annule et remplace la deuxième édition parue en 2007, et l’Amendement 1:2015. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) modifications techniques et rédactionnelles, qui résultent de la norme générale amendée IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 et IEC 60601-1:2005/AMD2:2020 et de ses normes collatérales IEC 60601-1-xx ;
b) modifications techniques et rédactionnelles qui résultent de la maintenance des références normatives ;
c) modifications techniques et rédactionnelles qui résultent des évolutions correspondantes des normes du CE 87 Ultrasons. En particulier, l’Article 201.11 concernant la protection contre les températures excessives et les autres dangers a été entièrement révisé.

General Information

• Status: Published
• Publication Date: 01-Jul-2024
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 34 - TC 62/SC 62B/MT 34
• Current Stage: PPUB - Publication issued
• Start Date: 07-Jun-2024
• Completion Date: 02-Jul-2024

Relations

• Revises: IEC 60601-2-37:2007 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-37:2007/AMD1:2015 - Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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
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.
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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
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.
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
...

IEC 60601-2-37 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment

Appareils électromédicaux –
Partie 2-37: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
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
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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
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and withdrawn publications. content tailored to your needs.

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IEC 60601-2-37 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-37: Particular requirements for the basic safety and essential performance

of ultrasonic medical diagnostic and monitoring equipment

Appareils électromédicaux –
Partie 2-37: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55, 17.140.50 ISBN 978-2-8322-8920-4

– 2 – IEC 60601-2-37:2024 © IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
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 . 29
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 31
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 ME SYSTEMS . 31
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 31
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment
(EMS) . 33
Annexes . 34
Annex AA (informative) Particular guidance and rationale . 35
Annex BB (informative) Guidance in classification according to CISPR 11 . 43
Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR . 44
Annex DD (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES . 48
Annex EE (informative) Acoustic output table intended for third parties . 51
Bibliography . 54
Index of defined terms . 58

Figure AA.1 – Method a) for an external probe . 38
Figure AA.2 – Method b) for an external probe . 39
Figure AA.3 – Method b) for an external probe . 39
Figure DD.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers . 50

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 . 28
Table CC.1 – Relative importance of maintaining low exposure indices in various
scanning situations . 46
Table DD.1 – Acoustic and thermal properties of tissues and materials . 48
Table DD.2 – Weight % pure components . 49
Table EE.1 – Example of acoustic output table for third parties . 52

– 4 – IEC 60601-2-37:2024 © 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
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 dir
...