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
Current Stage
PPUB - Publication issued
Start Date
09-Aug-2007
Completion Date
09-Aug-2007
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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
IEC 60601-2-37:2007
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
CODE PRIX
ICS 11.040.55; 17.140.50 ISBN 2-8318-9266-X
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
60601-2-37 © IEC:2007 – 3 –

Table DD.1 – Acoustic and thermal properties of tissues & materials ....................................35

Table DD.2 – Weight % pure components .............................................................................36

---------------------- Page: 5 ----------------------
– 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

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 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.

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) 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.
---------------------- Page: 6 ----------------------
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

– “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this particular standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title: Medical electrical

equipment, can be found on the IEC website

The committee has decided that the contents of this publication will remain unchanged until

the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in

the data related to the specific publication. At this date, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
---------------------- Page: 7 ----------------------
– 6 – 60601-2-37 © IEC:2007
INTRODUCTION

In this particular standard, safety requirements additional to those in the general standard are

specified for ULTRASONIC DIAGNOSTIC EQUIPMENT.

A general guidance and rationale for the requirements of this particular standard are given in

Annex AA.

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.

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.
---------------------- Page: 8 ----------------------
60601-2-37 © IEC:2007 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-37: Particular requirements for the basic safety
and essential performance of ultrasonic medical
diagnostic and monitoring equipment
The clauses and subclauses of the general standard apply except as follows:
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 *Scope
Addition:

This International Standard 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 standard are not covered by specific requirements in this standard

except in 7.2.13 and 8.4.1 of this standard.
NOTE See also subclause 4.2 of this standard.

This particular standard 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.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217.

201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard as appropriate for the particular ME EQUIPMENT under

consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

A requirement of a particular standard takes priority over the general standard.
---------------------- Page: 9 ----------------------
– 8 – 60601-2-37 © IEC:2007

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of sections, clauses and subclauses of this particular standard corresponds to

that of the general standard with the prefix “201” (e.g. 201.1 in this particular standard

addresses the content of Clause 1 of the general standard) or applicable collateral standard

with the prefix “20x” where x is the final digit(s) of the collateral standard document number

(e.g. 202.6 in this particular standard addresses the content of Clause 6 of the 60601-1-2

collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the

60601-1-3 collateral standard, etc.). The changes to the text of the general standard are

specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional

items aa), bb), etc.

Subclauses or figures which are additional to those of a collateral standard are numbered

starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-

1-2, 203 for IEC 60601-1-3, etc.

The term "this standard" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding section, clause or subclause in this particular standard, the

section, clause or subclause of the general standard or applicable collateral standard,

although possibly not relevant, applies without modification; where it is intended that any part

of the general standard or applicable collateral standard, although possibly relevant, is not to

be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies except as follows:
Addition:

IEC 62359, Ultrasonics – Field characterization – Test methods for the determination of

thermal and mechanical indices related to medical diagnostic ultrasonic fields
201.3 Terminology and definitions

For the purposes of this document, the terms and definitions given in the general standard

and in IEC 62359, as well as the following additions apply:
NOTE 1 An index of defined terms is given after the Bibliography.

NOTE 2 A list of symbols used in this particular standard is found in Table 201.101.

---------------------- Page: 10 ----------------------
60601-2-37 © IEC:2007 – 9 –
201.3.201
BONE THERMAL INDEX

THERMAL INDEX for applications, such as foetal (second and third trimester) or neonatal

cephalic (through the fontanelle) applications, in which the ultrasound beam passes through

soft tissue and there is bone close to a focal region
Symbol: TIB
Unit: None
NOTE See IEC 62359 for methods of determining the BONE THERMAL INDEX.
201.3.202
COMBINED-OPERATING MODE
mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that combines more than one
DISCRETE-OPERATING MODE
201.3.203
CRANIAL-BONE THERMAL INDEX

THERMAL INDEX for applications, such as paediatric and adult cranial applications, in which the

ultrasound beam passes through bone near the beam entrance into the body
Symbol: TIC
Unit: None
NOTE See IEC 62359 for methods of determining the CRANIAL-BONE THERMAL INDEX
201.3.204
DEFAULT SETTING

specific state of control the ULTRASONIC DIAGNOSTIC EQUIPMENT will enter upon power-up, new

PATIENT select, or change from non-foetal to foetal applications
201.3.205
DISCRETE-OPERATING MODE

mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT in which the purpose of the excitation

of the ULTRASONIC TRANSDUCER or ULTRASONIC TRANSDUCER element group is to utilise only

one diagnostic methodology
201.3.206
FULL SOFTWARE CONTROL OF ACOUSTIC OUTPUT
means by which the ULTRASONIC DIAGNOSTIC EQUIPMENT manages the acoustic output
independent of direct OPERATOR control
201.3.207
INVASIVE TRANSDUCER ASSEMBLY

a transducer which, in whole or in part, penetrates inside the body, either through a body

orifice or through the surface of the body
201.3.208
MECHANICAL INDEX
the displayed parameter representing potential cavitation bioeffects
Symbol: MI
Unit: None
NOTE See IEC 62359 for methods of determining the MECHANICAL INDEX.
201.3.209
MULTI-PURPOSE ULTRASONIC DIAGNOSTIC EQUIPMENT

ULTRASONIC DIAGNOSTIC EQUIPMENT that is intended for more than one clinical application

---------------------- Page: 11 ----------------------
– 10 – 60601-2-37 © IEC:2007
201.3.210
NON-SCANNING MODE
mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that involves a sequence of

ultrasonic pulses that give rise to ultrasonic scan lines that follow the same acoustic path

201.3.211
PRUDENT USE STATEMENT

affirmation of the principle advising avoidance of high exposure levels and long exposure

times while acquiring only information which is clinically required
201.3.212
SCANNING MODE
mode of operation of ULTRASONIC DIAGNOSTIC EQUIPMENT that involves a sequence of

ultrasonic pulses that give rise to scan lines that do not follow the same acoustic path

201.3.213
SOFT TISSUE THERMAL INDEX
THERMAL INDEX related to soft tissues
Symbol: TIS
Unit: None

NOTE 1 See IEC 62359 for methods of determination of the SOFT-TISSUE THERMAL INDEX.

NOTE 2 For the purposes of this document, “soft tissue“ includes all body tissues and fluids but excludes skeletal

tissues.
201.3.214
THERMAL INDEX

ratio of attenuated acoustic power at a specified point to the attenuated acoustic power

required to raise the temperature at that point in a specific tissue model by 1 °C.

Symbol: TI
Unit: None
NOTE See IEC 62359 for methods of determining the THERMAL INDEX
201.3.215
TRANSDUCER ASSEMBLY

the transducer housing (probe), any associated electronic circuitry, the active ultrasonic

transducer module, and any liquids contained in the housing and the integral cable that

connects the transducer probe to an ultrasound console
201.3.216
TRANSMIT PATTERN

combination of a specific set of transducer beam-forming characteristics (determined by the

transmit aperture size, apodisation shape, and relative timing/phase delay pattern across the

aperture, resulting in a specific focal length and direction), and an electrical drive waveform of

a specific fixed shape but variable amplitude
201.3.217
ULTRASONIC DIAGNOSTIC EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT that is intended for ultrasonic medical examination
201.3.218
ULTRASONIC TRANSDUCER

device capable of converting electrical energy to mechanical energy and/or mechanical

energy to electrical energy, both within the ultrasonic frequency range
---------------------- Page: 12 ----------------------
60601-2-37 © IEC:2007 – 11 –
Table 201.101 – List of symbols
Symbol Term Reference
A = -12dB OUTPUT BEAM AREA IEC 62359, 3.25
aprt
d = EQUIVALENT BEAM DIAMETER IEC 62359, 3.22
f = ACOUSTIC WORKING FREQUENCY IEC 62359, 3.2
awf
I = ATTENUATED PULSE-AVERAGE INTENSITY IEC 62359, 3.5
pa,α
I = PULSE-INTENSITY INTEGRAL IEC 62359, 3.32
I = ATTENUATED PULSE-INTENSITY INTEGRAL IEC 62359, 3.6
pi,α
I = SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY IEC 62359, 3.38
spta
I (z) = ATTENUATED TEMPORAL-AVERAGE INTENSITY IEC 62359, 3.8
ta, α
MI = MECHANICAL INDEX IEC 62359, 3.23
P = OUTPUT POWER IEC 62359, 3.27
P = ATTENUATED OUTPUT POWER IEC 62359, 3.3
P = ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE IEC 62359, 3.4
r,α
P = PEAK-RAREFACTIONAL ACOUSTIC PRESSURE IEC 62359, 3.28
prr = PULSE REPETITION RATE IEC 62359, 3.34
TI = THERMAL INDEX IEC 62359, 3.41
TIB = BONE THERMAL INDEX IEC 62359, 3.11
TIC = CRANIAL-BONE THERMAL INDEX IEC 62359, 3.15
TIS = SOFT-TISSUE THERMAL INDEX IEC 62359, 3.37
t = PULSE DURATION IEC 62359, 3.31
X, Y = -12dB OUTPUT BEAM DIMENSIONS IEC 62359, 3.26
z = DEPTH FOR BONE THERMAL INDEX IEC 62359, 3.17
z = BREAK-POINT DEPTH IEC 62359, 3.13
z = DEPTH FOR SOFT-TISSUE THERMAL INDEX IEC 62359, 3.18
201.4 General requirements
Clause 4 of the general standard applies except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

Table 201.102 lists the potential sources of unacceptable risk identified to characterize the

ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT and the subclauses in which

the requirements are found.
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Table 201.102 – Distributed essential performance requirements
Requirement Subclause

Free from noise on a waveform or artefacts or distortion in an image or error of a displayed

numerical value which cannot be attributed to a physiological effect and which may alter the 202.6.2.1.10

diagnosis.

Free from the display of incorrect numerical values associated with the diagnosis to be

202.6.2.1.10
performed .
201.12.4.2
Free from the display of incorrect safety-related indications.
202.6.2.1.10
201.10.101
Free from the production of unintended or excessive ultraso
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