BS DD IEC TS 62558-2011 Ultrasonics Real-time pulse-echo scanners Phantom with cylindrical artificial cysts in tissue-mimicking material and method for evaluation and periodic test.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationUltrasonics Real-time pulse-echo scanners Phantom with cylindrical, artificial cysts in tissue-mimicking material and method for evaluation and periodic testing of 3D-distributio

2、ns of void-detectability ratio (VDR)DD IEC/TS 62558:2011National forewordThis Draft for Development is the UK implementation of IEC/TS 62558:2011. The UK participation in its preparation was entrusted to Technical CommitteeEPL/87, UltrasonicsA list of organizations represented on this committee can

3、be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 61959 5 ICS 11.040.55; 17.140.50Compliance with a British Standard cannot confer immunity from leg

4、al obligations.This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 30 June 2011.Amendments issued since publicationAmd. No. Date Text affectedDRAFT FOR DEVELOPMENTDD IEC/TS 62558:2011IEC/TS 62558Edition 1.0 2011-03TECHNICALSPECIFICATIONUltra

5、sonics Real-time pulse-echo scanners Phantom with cylindrical, artificial cysts in tissue-mimicking material and method for evaluation and periodic testing of 3D-distributions of void-detectability ratio (VDR) INTERNATIONAL ELECTROTECHNICAL COMMISSION XICS 17.140.50 PRICE CODEISBN 978-2-88912-377-3

6、Registered trademark of the International Electrotechnical Commission colourinsideDD IEC/TS 62558:2011 2 TS 62558 IEC:2011(E) CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope . 7 2 Normative references . 7 3 Terms and definitions . 7 4 Symbols . 11 5 Ambient conditions of measurement with the phantom

7、12 6 Specification of TMM 3D artificial anechoic-cyst phantom . 12 6.1 3D-phantom concept . 12 6.2 General phantom specification 12 6.3 TMM specifications: . 12 6.4 Anechoic targets . 13 6.5 Phantom enclosure 13 6.6 Scanning surface: . 13 6.7 Dimensions . 13 6.8 Phantom stability . 14 6.9 Digitized

8、image data 14 7 Principle of measurement using the 3D anechoic void phantom 15 7.1 General . 15 7.2 Analysis 15 Annex A (informative) Description of construction of an example phantom and test results 17 Annex B (informative) System description 37 Annex C (informative) Rationale 38 Annex D (informat

9、ive) Uniformity measurement . 41 Bibliography 48 Figure A.1 Example of measurement test equipment 17 Figure A.2a) Package of TMM slices containing alternating void slices and attenuation slices of polyurethane foam 19 Figure A.2b) Holes of different diameters in the void slices allow the use of the

10、phantom with different ultrasound frequencies (1 15 MHz) . 19 Figure A.2 TMM slices . 19 Figure A.3 Structure of foam 19 Figure A.4 C-images of voids . 20 Figure A.5 Experimental confirmation of Rayleigh distribution with attenuating TMM 21 Figure A.6 Speed of sound in saltwater 22 Figure A.7 Phanto

11、m with motor drive and two types of adapters 22 Figure A.8 B-, D-, C- images and grey scale 24 Figure A.9 Illustration of the VDR calculation for a ROI consisting of a single line 25 Figure A.10 B-C-D planes 26 Figure A.11 Principle of the ultrasound scanning array and beam 27 Figure A.12 Schematic

12、of B-D-C planes . 28 DD IEC/TS 62558:2011TS 62558 IEC:2011(E) 3 Figure A.13 3D-Phantom images . 29 Figure A.14 B-D-C images and VDR 30 Figure A.15a) Example: Curved Array, 40-mm radius, 3,5MHz with good VDR-values. . 31 Figure A.15b) Example: Curved Array, 40-mm radius, 3,5MHz with poor VDR-values 3

13、1 Figure A.15 VDR-values 31 Figure A.16 Example: Linear array transducer 13 MHz . 32 Figure A.17 Interpretation of VDR parameter . 33 Figure A.18 Explanation of saturation (0-255 grey-scale range) . 34 Figure A.19a) Voids 2,5 mm . 35 Figure A.19b) Voids 3,0 mm . 35 Figure A.19c) Voids 4 ;0 mm 35 Fig

14、ure A.19 Saturation effect . 35 Figure A.20 Void spot analysis . 35 Figure A.21a) Local dynamic curve 36 Figure A.21b) Expected envelope of VDR 36 Figure 21 Local dynamic range 36 Figure C.1 Autocorrelation function 39 Figure C.2a) Autocorrelation function at 4,06 cm depth 40 Figure C.2b) Autocorrel

15、ation function at 9,08 cm depth 40 Figure C.2 Autocorrelation function dependence on depth 40 Figure C.3 Autocorrelation function at 10,94 cm depth . 40 Figure D.1a) Uniformity test with related linear or curved array transducer . 42 Figure D.1b) Fixed pattern in B-image . 42 Figure D.1 Uniformity t

16、est 42 Figure D.2a) B-D-C image and fixed pattern in C-image . 43 Figure D.2b) Grey scale display of full array 43 Figure D.2 Uniformity test Additional features . 43 Figure D.3 Linear transducer with reference tape . 44 Figure D.4 Interpretation of simulated transducer failure when half of the prob

17、e is covered by five layers of 50-mm fabric tape 45 Figure D.5 Disconnected elements, example with linear transducer . 46 Figure D.6 Example with curved array transducer and reference tape 47 DD IEC/TS 62558:2011 4 TS 62558 IEC:2011(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ULTRASONICS REAL-TIM

18、E PULSE-ECHO SCANNERS PHANTOM WITH CYLINDRICAL, ARTIFICIAL CYSTS IN TISSUE-MIMICKING MATERIAL AND METHOD FOR EVALUATION AND PERIODIC TESTING OF 3D-DISTRIBUTIONS OF VOID-DETECTABILITY RATIO (VDR) FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardi

19、zation 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 Interna

20、tional 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 i

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22、 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

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26、rried out by independent certification bodies. 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 C

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28、n 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

29、be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. In exceptional circumstances, a technical committee may propose the publication of a technical specification when the required support cannot be obtaine

30、d for the publication of an International Standard, despite repeated efforts, or the subject is still under technical development or where, for any other reason, there is the future but no immediate possibility of an agreement on an International Standard. Technical specifications are subject to rev

31、iew within three years of publication to decide whether they can be transformed into International Standards. IEC 62558, which is a technical specification, has been prepared by IEC technical committee 87: Ultrasonics. DD IEC/TS 62558:2011TS 62558 IEC:2011(E) 5 The text of this technical specificati

32、on is based on the following documents: Enquiry draft Report on voting 87/434/DTS 87/458/RVC Full information on the voting for the approval of this technical specification can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO

33、/IEC Directives, Part 2. 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:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be transformed into

34、an International standard, reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be us

35、eful for the correct understanding of its contents. Users should therefore print this document using a colour printer. DD IEC/TS 62558:2011 6 TS 62558 IEC:2011(E) INTRODUCTION This technical specification provides an example of a measurement method and of a test phantom. The specified method and tes

36、t equipment permit operation without knowledge of proprietary information of the diagnostic ultrasonic equipment manufacturer. This technical specification describes desirable specifications and performance characteristics of a tissue-mimicking material (TMM) 3D artificial-cyst phantom. An example i

37、ncluding design of a realized and conforming phantom is given. The described results are independent of applied electronic and design architecture of diagnostic ultrasound systems and related transducers suitable for testing with the phantom. Medical diagnostic ultrasound systems and related transdu

38、cers need periodic testing as the quality of medical decisions based on ultrasonic images may decrease over time due to progressive degradation of essential systems characteristics. The TMM phantom is intended to be used to measure and to enable documentation of changes in void-detectability ratio i

39、n periodic tests over years of use. The example of phantom design uses sliced TMM arranged as alternating “cyst-slices“ and “attenuation-slices“. It allows measurement along all three axes of the ultrasonic beam (axial, azimuthal and elevation) to determine the void-detectability ratio depending on

40、the depth in the image generated from a transducer. The basis of the design concept and measurement method is anechoic, artificial cysts, representing idealized pancreatic ducts in the human body, and the measurement of the void-detectability ratio inside the images of these artificial cysts. The im

41、ages of the artificial cysts should appear anechoic. The measurement of void-detectability ratio quantifies the diagnostic ultrasound systems ability to properly represent these objects. Increased artifactual signals appearing within images of these artificial cysts indicate a degradation of certain

42、 image parameters. A certain level of artifactual signals is to be expected for any ultrasound system, due to the emitted beams shape and the transducers receive characteristics. Any increase in these artifactual signals may be caused, for example, by grating- and side-lobes that may occur due to, f

43、or example, partial or total depolarisation of elements, delamination between transducer elements and lens, or corrosion. The measurement procedure allows a reliably and reproducible determination of the visibility limits of small voids, an important image parameter of an ultrasound diagnostic syste

44、m over the time of use, by applying dedicated acquisition, processing and documentation software. Four informative annexes are provided: Annex A Description of construction of an example phantom and test results; Annex B System description; Annex C Rationale; Annex D Uniformity measurement. DD IEC/T

45、S 62558:2011TS 62558 IEC:2011(E) 7 ULTRASONICS REAL-TIME PULSE-ECHO SCANNERS PHANTOM WITH CYLINDRICAL, ARTIFICIAL CYSTS IN TISSUE-MIMICKING MATERIAL AND METHOD FOR EVALUATION AND PERIODIC TESTING OF 3D-DISTRIBUTIONS OF VOID-DETECTABILITY RATIO (VDR) 1 Scope This technical specification specifies ess

46、ential characteristics of a phantom and method for the measurement of void-detectability ratio for medical ultrasound systems and related transducers. It is restricted to the aspect of long-term reproducibility of testing results. This technical specification establishes: important characteristics a

47、nd requirements for a TMM 3D artificial cyst phantom using anechoic voids; a design example of a 3D artificial cyst phantom, the necessary test equipment and use of relevant computer software algorithms. This technical specification is currently applicable for linear array transducers. A uniformity

48、test prior to void-detectability ratio (VDR) measurement is recommended. NOTE The basic concept of the 3D artificial-cyst phantom may also be valid for other types of ultrasound transducers; however there is a need for further verification (see Annex D). 2 Normative references The following referenc

49、ed documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including amendments) applies. IEC 60050-802, International Electrotechnical Vocabulary, Part 802: Ultrasonics 3 Terms and definitions For the purposes of this document, the terms and definit