1、 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) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no
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10、CAL REPORT Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices INTERNATIONAL ELECTROTECHNICAL COMMISSION XD ICS 17.140.50 PRICE CODE ISBN 978-2-88910-922-7 Registered trademark of the International Electrotechnical Commission 2 TR 62649 IEC:2010(E) CONTENT
11、S 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 intensities11 3.4 Strong focusing .12 3.5 Nonlinear harmonics .12 3.6 Acoustic saturation and nonlinear loss 12 3.7 Relevant parameters .13 4 Su
12、rvey of experts .13 5 Existing literature for measurement of HITU fields 18 6 Discussion26 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 measure
13、ment of intensity 28 6.6 Measurement of temperature rise and temperature distribution .28 6.7 Thermal dose 28 6.8 Cavitation activity30 6.9 Registration of the HITU field with the targeting system.30 6.10 Tissue-mimicking material for QA/engineering evaluation30 6.11 Electrical properties of the tra
14、nsducer .31 6.12 Treatment monitoring 31 6.13 Equipment safety and essential performance.31 6.14 Tissue properties.31 7 Recommendations32 7.1 Items for immediate development32 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
15、in TC 87 32 7.1.3 Specification and measurement of field parameters as a Technical Specification (TS) in TC 8732 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
16、 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.3
17、3 TR 62649 IEC:2010(E) 3 Annex A (informative) Detailed responses to questionnaire34 Annex B (informative) Definitions in selected ultrasound standards54 Annex C (informative) Chinese national standard.67 Bibliography87 Figure 1 Radiation force balance system using absorbing target (upward beam)77 F
18、igure 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
19、 Correction factor of plane wave for the acoustic field of a circular plane piston ultrasonic transducer82 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 field
20、s 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 1) The International Electrotechnical Commission (IEC) is a worldwide organizat
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32、hat which is normally published as an International Standard, for 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
33、/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
34、 of this publication will remain unchanged until the stability 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. A bilingual versio
35、n of this publication may be issued at a later date. 6 TR 62649 IEC:2010(E) INTRODUCTION This Technical Report is concerned with standards for high intensity therapeutic ultrasound (HITU) and concentrates on applications that destroy tissue by heating which may or may not be accompanied by acoustic
36、cavitation and other mechanisms. The purpose of the report is to identify topics where there is a consensus that the development of international standards would benefit the industries and/or patients involved with these forms of therapeutic ultrasound. The shortcomings of existing standards as they
37、 may be related to the applications of interest are reviewed. It is not its purpose to propose or evaluate specific alternative measurement methods which may be more reliably applied to HITU or other therapeutic equipment. Physiotherapy and lithotripsy are excluded as there are existing standards fo
38、r these established uses. Lower intensity applications such as enhanced bone healing or ultrasound-induced gene therapy are not explicitly considered. The use of HITU has advanced to the point where systems have achieved clinical approval for general use in several countries. Medical applications an
39、d product development are continuing rapidly. The corresponding products of many companies have been approved for marketing and clinical applications. Fast development in preclinical medicine, clinic medicine, and product manufacture has created an urgent need to standardize measurements of the basi
40、c acoustic parameters and the field characteristics of HITU. In order to promote the further development of HITU and to ensure its safe and effective use, international standards are required. TR 62649 IEC:2010(E) 7 REQUIREMENTS FOR MEASUREMENT STANDARDS FOR HIGH INTENSITY THERAPEUTIC ULTRASOUND (HI
41、TU) DEVICES 1 Scope This technical report is relevant to the measurement and specification of ultrasound fields intended for medical therapeutic purposes. Lithotripsy and physiotherapy are excluded, since there are existing International Standards for these applications. It establishes: topics where
42、 there is a consensus that the development of International Standards would benefit the industries and/or patients; topics where the writing of standards should start immediately; topics where the writing of technical specifications should start immediately in order to gain practical experience and
43、establish consensus prior to standardisation; topics which require future standardisation but where further research is required before initiating the writing of standards or technical specifications. This report addresses primarily the requirements for measurement standards related to high intensit
44、y therapeutic ultrasound (HITU) also known as high intensity focused ultrasound (HIFU) fields which are both high intensity and focused and where the main mechanism for action is thermal. However, aspects of the discussion, conclusions and any resulting standards or technical specifications may also
45、 be relevant to therapeutic applications which are either focused or high intensity or where the main mechanism is not thermal. Scientific literature has been reviewed and responses to a questionnaire which was sent to experts around the world are reported. 2 Background Recent years have seen a dram
46、atic rise in interest in using ultrasound as a surgical and therapeutic tool in its own right. Much of this growth has been due to the use of High Intensity Therapeutic Ultrasound (HITU) for tissue ablation in the treatment of cancers and conditions such as benign prostate hyperplasia (BPH). Here, u
47、ltrasound is brought to a focus within tissue with the intention of generating intensity levels sufficient to raise the local tissue temperature above 55 C. Like so much in ultrasound, this technique was first tested many years ago (Lynn et al, 1942; Wall et al, 1951, Fry et al, 1954), but recent ma
48、terials, computing and other technological advances have allowed it to come close to the medical mainstream. The ability to generate such high temperatures within tissue brings with it the absolute requirement to ensure that the treatment is delivered to the correct level and at the correct site. Th
49、is in turn means that accurate methods of predicting the dose and monitoring performance are required. Consequently, reliable measurement and characterisation methods are needed for this application above all others. However, HITU is not the only therapeutic application. Ultrasound physiotherapy, of course, has been widely used since the 1950s (Imig et al, 1954; Gersten, 1955) and lithotripsy since 1980 (Chaussy et al) for the destruction of kidney stones. More experime
