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

Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.

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

S'applique à la sécurité de base et aux performances essentielles des appareils de diagnostic à ultrasons. L'approche et la philosophie utilisées en rédigeant cette norme particulière de sécurité pour les appareils de diagnostic à ultrasons sont cohérentes avec celles des normes actuellement en vigueur de la série des CEI 60601-2-xx, qui s'appliquent à d'autres modalités de diagnostic, telles que les appareils à rayonnement X et les systèmes à résonance magnétique. Dans chacun des cas, la norme de sécurité est prévue pour prescrire une sophistication croissante de l'affichage des indicateurs de sortie et/ou des commandes, en fonction de l'augmentation des niveaux d'énergie dans le champ d'interrogation/d'exploration soumis au diagnostic. Ainsi, pour toutes ces modalités de diagnostic, il est de la responsabilité de l'opérateur d'appréhender le risque relatif à l'énergie de sortie de l'appareil de diagnostic à ultrasons et d'agir convenablement afin d'obtenir les informations de diagnostic requises, avec le risque minimum pour le patient. Cette deuxième édition annule et remplace la première édition publiée en 2001 et ses Amendement 1 (2004) et Amendement 2 (2005). La présente édition regroupe l'édition précédente et ses deux amendements dans un format compatible avec la CEI 60601-1:2005.

General Information

• Status: Published
• Publication Date: 08-Aug-2007
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• 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

Relations

• Amended By: 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
• Revises: IEC 60601-2-37:2001/AMD2:2005 - Amendment 2 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-37:2001/AMD1:2004 - Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023
• Revised: 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
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-37:2001 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-37
Edition 2.0 2007-08
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 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.

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et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
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IEC 60601-2-37
Edition 2.0 2007-08
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
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.55; 17.140.50 ISBN 2-8318-9266-X

– 2 – 60601-2-37 © IEC:2007
CONTENTS
FOREWORD.4
INTRODUCTION.6

201.1 Scope, object and related standards .7
201.2 Normative references.8
201.3 Terminology and definitions .8
201.4 General requirements.11
201.5 General requirements for testing ME EQUIPMENT .12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .12
201.7 ME EQUIPMENT identification, marking and documents .12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS .16
201.11 Protection against excessive temperatures and other HAZARDS .17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .21
201.13 Hazardous situations and fault conditions .22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23
201.15 Construction of ME EQUIPMENT .23
201.16 ME SYSTEMS.23
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .23
202.6 ELECTROMAGNETIC COMPATIBILITY .23

Annex AA (informative) Guidance and rationale for particular subclauses .26
Annex BB (informative) Guidance in classification according to CISPR 11 .31
Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR.32
Annex DD (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES .35

Bibliography.38

Index of defined terms .41

Figure DD.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers .37

Table 201.101 – List of symbols.11
Table 201.102 – Distributed essential performance requirements .12
Table 201.103 –Acoustic output reporting table .15
Table 201.104 – Overview of the tests noted under 201.11.1.3 .20
Table CC.1 – Relative importance of maintaining low exposure indices in various
scanning situations .34

60601-2-37 © IEC:2007 – 3 –
Table DD.1 – Acoustic and thermal properties of tissues & materials .35
Table DD.2 – Weight % pure components .36

– 4 – 60601-2-37 © IEC:2007
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
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5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-37 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 2001 and its
Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition
and its amendments into a form compatible with the parent IEC 60601-1:2005.
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62B/624/CDV 62B/657/RVC
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

60601-2-37 © IEC:2007 – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
...

IEC 60601-2-37 ®
Edition 2.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
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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
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IEC 60601-2-37 ®
Edition 2.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-2739-8

IEC 60601-2-37 ®
Edition 2.1 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – IEC 60601-2-37:2007
+AMD1:2015 CSV  IEC 2015
CONTENTS
FOREWORD . 4

INTRODUCTION . 7

INTRODUCTION TO AMENDMENT 1 . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 9

201.3 Terminology Terms and definitions . 10

201.4 General requirements . 15
201.5 General requirements for testing ME EQUIPMENT . 16
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents. 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 22
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 27
201.13 Hazardous situations and fault conditions . 29
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29
201.15 Construction of ME EQUIPMENT . 29
201.16 ME SYSTEMS . 29
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
202.6 ELECTROMAGNETIC COMPATIBILITY . 29

Annex AA (informative) Guidance and rationale for particular subclauses . 32
Annex BB (informative) Guidance in classification according to CISPR 11 . 38
Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR . 39
Annex DD (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES . 42
Annex EE (informative) Acoustic output table intended for 3rd parties . 45

Bibliography . 48

Index of defined terms . 51

Figure DD.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers . 44

Table 201.101 – List of symbols . 15
Table 201.102 – Distributed essential performance requirements . 16
Table 201.103 – Acoustic output reporting table . 20
Table 201.104 – Overview of the tests noted under 201.11.1.3 . 26
Table CC.1 – Relative importance of maintaining low exposure indices in various
scanning situations . 41

+AMD1:2015 CSV  IEC 2015
Table DD.1 – Acoustic and thermal properties of tissues & materials . 42

Table DD.2 – Weight % pure components . 43

– 4 – IEC 60601-2-37:2007
+AMD1:2015 CSV  IEC 2015
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 Publica
...