IEC TR 62649:2010

IEC/TR 62649 ®
Edition 1.0 2010-04
TECHNICAL
REPORT
Requirements for measurement standards for high intensity therapeutic
ultrasound (HITU) devices
IEC/TR 62649:2010(E)
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IEC/TR 62649 ®
Edition 1.0 2010-04
TECHNICAL
REPORT
Requirements for measurement standards for high intensity therapeutic
ultrasound (HITU) devices
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XD
ICS 17.140.50 ISBN 978-2-88910-922-7
– 2 – TR 62649 © IEC:2010(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Background .7
3 Limitations of existing standard methods .10
3.1 General .10
3.2 Very high pressures .11
3.3 Very high intensities .11
3.4 Strong focusing .12
3.5 Nonlinear harmonics .12
3.6 Acoustic saturation and nonlinear loss .12
3.7 Relevant parameters .13
4 Survey of experts .13
5 Existing literature for measurement of HITU fields .18
6 Discussion.26
6.1 General .26
6.2 Measurement of power .26
6.3 Specification of field parameters related pressure and intensity distribution.27
6.4 Robust methodology for measuring pressure at a point .27
6.5 Direct measurement of intensity .28
6.6 Measurement of temperature rise and temperature distribution .28
6.7 Thermal dose .28
6.8 Cavitation activity.30
6.9 Registration of the HITU field with the targeting system.30
6.10 Tissue-mimicking material for QA/engineering evaluation .30
6.11 Electrical properties of the transducer .31
6.12 Treatment monitoring .31
6.13 Equipment safety and essential performance.31
6.14 Tissue properties.31
7 Recommendations.32
7.1 Items for immediate development .32
7.1.1 General .32
7.1.2 Measurement of total output power as an International Standard or
as an amendment to IEC 61161 Ed.2 in TC 87 .32
7.1.3 Specification and measurement of field parameters as a Technical
Specification (TS) in TC 87.32
7.1.4 Equipment safety and essential performance as a Particular
Standard in the 60601 series in TC 62.32
7.2 Items for development within 5 years.32
7.2.1 General .32
7.2.2 Robust method of measuring pressure.32
7.2.3 Measurement of temperature.33
7.2.4 Electrical properties of therapeutic transducers .33
7.2.5 Registration of the HITU field with the targeting system .33
7.2.6 Tissue-mimicking material for QA/engineering evaluation .33
7.3 Items requiring extensive further research.33

TR 62649 © IEC:2010(E) – 3 –
Annex A (informative) Detailed responses to questionnaire.34
Annex B (informative) Definitions in selected ultrasound standards.54
Annex C (informative) Chinese national standard.67
Bibliography.87

Figure 1 – Radiation force balance system using absorbing target (upward beam).77
Figure 2 – Radiation force balance system using different measuring system
(downward beam) .78
Figure 3 – Hydrophone scanning configuration for measuring HIFU acoustic field
(upward beam).78
Figure 4 – Hydrophone scanning measurement configuration for measuring HIFU
acoustic field (downward beam).79
Figure 5 – Correction factor of plane wave for the acoustic field of a circular plane
piston ultrasonic transducer .82

Table 1 – General characteristics of ultrasound used for different therapeutic
applications .8
Table 2 – International standards and related documents for the measurement of
medical ultrasound fields .9
Table 3 – Questions and summarised answers .14

– 4 – TR 62649 © IEC:2010(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
REQUIREMENTS FOR MEASUREMENT STANDARDS
FOR HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) DEVICES

FOREWORD
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example "state of the art".
IEC 62649, which is a technical report, has been prepared by committee TC 87: Ultrasonics.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
87/420/DTR 87/428/RVC
Full information on the voting for the approval of this technical report 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 2.

TR 62649 © IEC:2010(E) – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://web
...