IEC 60601-2-37:2001

INTERNATIONAL IEC
STANDARD
60601-2-37
First edition
2001-07
Medical electrical equipment –
Part 2-37:
Particular requirements for the safety
of ultrasonic medical diagnostic
and monitoring equipment
Appareils électromédicaux –
Partie 2-37:
Règles particulières de sécurité pour les appareils
de diagnostic et de surveillance médicaux à ultrasons

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INTERNATIONAL IEC
STANDARD
60601-2-37
First edition
2001-07
Medical electrical equipment –
Part 2-37:
Particular requirements for the safety
of ultrasonic medical diagnostic
and monitoring equipment
Appareils électromédicaux –
Partie 2-37:
Règles particulières de sécurité pour les appareils
de diagnostic et de surveillance médicaux à ultrasons

 IEC 2001  Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
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Commission Electrotechnique Internationale
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International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-37  IEC:2001(E)

CONTENTS
FOREWORD.4

INTRODUCTION.6

SECTION ONE: GENERAL
1 Scope and object .7

2 Terminology and definitions .8

6 Identification, marking and documents .19
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .21
20 Dielectric strength.22
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*35 Acoustical energy (including ultrasonic) .22
*36 Electromagnetic compatibility.22
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.23
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
and disinfection .25
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION

AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .25
51 Protection against hazardous output .26
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS

60601-2-37 © IEC:2001(E) – 3 –

Annex AA (normative) Terminology – Index of defined terms .28

Annex BB (informative) Guidance and rationale for particular subclauses .30

Annex CC (informative) Guidance in classification according to CISPR 11.33

Annex DD (normative) Test methods for determining the MECHANICAL INDEX

and the THERMAL INDEX.34

Annex EE (informative) Relationships with other standards.39

Annex FF (informative) Guidance notes for measurement of OUTPUT POWER

in SCANNING MODE .40

Annex GG (informative) Rationale and derivation of index models .44
Annex HH (informative) Guidance on the interpretation of TI and MI to be used
to inform the OPERATOR.58
Bibliography.61
Figure FF.1 – Suggested 1 cm-wide aperture mask .42
Figure FF.2 – Suggested orientation of probe, mask slit, and RFB target .42
Figure FF.3 – Suggested orientation of probe, mask slit, and 1 cm RFB target.42
Figure GG.2a – Focused transducer with a large aperture .56
Figure GG.2b – Focused transducer with smaller aperture (≥1 cm ) .56
Figure GG.2c – Focused transducer with a weak focus (A > 1 cm ) .57
eq
Figure GG.2d – Weakly focused transducer .57
Table 101 – Acoustic output reporting table .21
Table DD.1 – Summary of combination formulae for each
of the THERMAL INDEX categories.38
Table DD.2 – Summary of the acoustic quantities required for the determination
of the indices .38
Table GG.1 – THERMAL INDEX categories and models .46
Table GG.2 – THERMAL INDEX formulae.50
Table HH.1 – Relative importance of maintaining low exposure indices
in various scanning situations .59

– 4 – 60601-2-37  IEC:2001(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-37: Particular requirements for the safety

of ultrasonic diagnostic and monitoring equipment

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-37 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/428/FDIS 62B/440/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes AA and DD form an integral part of this Particular Standard.
Annexes BB, CC, EE, FF, GG and HH are for information only.

60601-2-37 © IEC:2001(E) – 5 –

In this Particular Standard, the following print types are used:

– requirements, compliance with which can be tested, and definitions: in roman type

– notes, explanations, advice, introductions, general statements, exceptions, and references: in smaller type

– test specifications: in italic type

– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2

AND IEC 60601-1: IN SMALL CAPITALS.

The committee has decided that the contents of this publication will remain unchanged until 2002.
At this date, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this standard may be issued at a later date.

– 6 – 60601-2-37  IEC:2001(E)

INTRODUCTION
In this Particular Standard, safety requirements additional to those in the General Standard

are specified for ULTRASONIC DIAGNOSTIC EQUIPMENT.

Guidance and a rationale for the requirements of this Particular Standard are given below.

Knowledge of the reasons for these requirements will not only facilitate the proper application
of this Particular Standard but will, in due course, expedite any revision necessitated by

changes in clinical practice or as a result of developments in technology.

General guidance and rationale
The approach and philosophy used in drafting this particular standard for safety of
ULTRASONIC DIAGNOSTIC EQUIPMENT are consistent with those in current standards in the
IEC 60601-2 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 equipment, and to act appropriately in order to obtain
the needed diagnostic information with the minimum risk to the PATIENT.
The reference given in the bibliography, UD-3 Rev.1, 1998: Standard for real-time display of
thermal and mechanical acoustic output indices on diagnostic ultrasound equipment will be
replaced by an IEC standard when available.
It should be noted that although UD-3 Rev.1, 1998 was developed as a national standard, it
has since been referenced by about 24 countries world wide and by all internationally
operating manufacturers and test houses; regulative authorities also follow the standard as it
has become a de facto international standard. The material taken from UD-3 Rev.1, 1998
forms only a part of this Particular Standard and is used to generate the present International
Standard which will be replaced by a revised edition within one year.
The standards currently under development, IEC 61973
...