1、BSI Standards PublicationUltrasonics Pulse-echo scanners Low-echo spherephantoms and method for performance testing of gray-scale medical ultrasoundscanners applicable to a broadrange of transducer typesPD IEC/TS 62791:2015National forewordThis Published Document is the UK implementation of IEC/TS 6
2、2791:2015.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/87, Ultrasonics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are
3、 responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 80391 8ICS 11.040.50; 17.140.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the author
4、ity of theStandards Policy and Strategy Committee on 30 September 2015.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD IEC/TS 62791:2015IEC TS 62791 Edition 1.0 2015-09 TECHNICAL SPECIFICATION Ultrasonics Pulse-echo scanners Low-echo sphere phantoms and method fo
5、r performance testing of gray-scale medical ultrasound scanners applicable to a broad range of transducer types INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.50; 17.140.50 ISBN 978-2-8322-2902-6 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you
6、obtained this publication from an authorized distributor. colourinsidePD IEC/TS 62791:201 2 IEC TS 62791:2015 IEC 2015 CONTENTS FOREWORD . 6 INTRODUCTION . 8 1 Scope 10 2 Normative references 10 3 Terms and definitions 10 4 Symbols 12 5 General and environmental conditions . 13 6 Equipment required
7、. 14 6.1 General . 14 6.2 Phantom geometries . 14 6.2.1 Phantoms for use in the frequency range 2 MHz to 7 MHz . 14 6.2.2 Phantoms for use in the frequency range 7 MHz to 15 MHz including “micro-convex“ arrays 14 6.2.3 Total internal-reflection surfaces 15 6.2.4 Spatially random distribution of low-
8、echo spheres 15 6.3 Ultrasonic properties of the tissue-mimicking (TM) phantoms 15 7 Data acquisition assuming a spatially random distribution of low-echo spheres . 16 7.1 Methodology . 16 7.2 Storage of digitized image data . 17 7.3 Digital image files available from the scanner itself . 18 7.4 Ima
9、ge archiving systems . 18 8 Automated data analysis for quantifying low-echo sphere detectability 18 8.1 General . 18 8.2 Computation of mean pixel values (MPVs) 18 8.3 Determination of the LSNRm-value for a given depth interval . 21 8.3.1 Preliminaries . 21 8.3.2 Computation of the LSNRn-values and
10、 LSNRm-value in a given depth interval 21 8.3.3 Standard error corresponding to each LSNRn-value 21 Annex A (informative) Example of a phantom for performance testing in the 2 MHz to 7 MHz frequency range . 22 Annex B (informative) Illustrations of the computation of LSNRm-values as a function of de
11、pth 24 Annex C (informative) Sufficient number of data images to assure reproducibility of results 29 C.1 General . 29 C.2 Phantom with low-echo sphere diameter 3,2 mm, having 2 spheres per millilitre . 29 C.3 Phantom with 2 mm-diameter, low-echo spheres and 8 spheres per millilitre 32 Annex D (info
12、rmative) Example of a phantom for performance testing in the 7 MHz to 15 MHz frequency range . 36 Annex E (informative) Determination of low-echo sphere positions to within D/8 in x, y and z Cartesian coordinates 39 E.1 Procedure . 39 E.2 Argument for the choice of seven MPV nearest-neighbour sites
13、for determining the centres of low-echo spheres 40 PD IEC/TS 62791:2015IEC TS 62791:2015 IEC 2015 3 Annex F (informative) Test of total internal reflection produced by alumina and plate-glass, plane reflectors . 41 Annex G (informative) Results of a test of reproducibility of LSNRmversus depth for a
14、 phantom with 4 mm-diameter low-echo spheres and 2 spheres per millilitre 48 Annex H (informative) Results for low-echo sphere-concentration dependence of LSNRmversus depth for phantoms with 4 mm-diameter spheres . 50 Annex I (informative) Results for low-echo sphere-concentration dependence of LSNR
15、m versus depth for phantoms with 3,2 mm-diameter spheres 53 Annex J (informative) Comparison of two different makes of scanner with similar transducers and console settings 57 Annex K (informative) Special considerations for 3-D probes 59 K.1 3-D probes operating in 2-D imaging mode . 59 K.2 2-D arr
16、ays operating in 3-D imaging mode for determining LSNRm-values as a function of depth for reconstructed images . 59 K.3 Mechanically driven 3-D probes operating in 3-D imaging mode 59 Bibliography 60 Figure 1 Flow chart 17 Figure 2 Schematic of an image plane . 20 Figure A.1 End view of the phantom
17、applicable for 2 MHz to 7 MHz showing the spatially random distribution of 4-mm diameter low-echo spheres . 22 Figure A.2 Top view of phantom with 4 mm-diameter, low-echo spheres 23 Figure B.1 Convex-array image of a prototype 4 mm-diameter low-echo sphere phantom for use in the 2 MHz to 7 MHz frequ
18、ency range 24 Figure B.2 Auxiliary figures relating to Figure B.1 25 Figure B.3 Results corresponding to Figures B.1 and B.2, demonstrating reproducibility . 25 Figure B.4 Results corresponding to Figures B.1, B.2 and B.3 . 26 Figure B.5 One of 80 parallel linear-array images of the phantom containi
19、ng 4 mm-diameter, low-echo spheres, at 4 MHz with focus at 3 cm . 26 Figure B.6 Three successive images of the set of 80, separated by D/4 equal to 1 mm 27 Figure B.7 Results for the 4 cm-wide, 3 cm-focus, linear array addressed in Figures B.5 and B.6 . 27 Figure B.8 Results for the 4 cm-wide, 3 cm-
20、focus, linear array addressed in Figures B.5, B.6 and B.7, using all 80 image frames corresponding to Figure B.7 . 28 Figure C.1 One image obtained from a phantom containing 3,2 mm-diameter, low-echo spheres by using a 4 MHz linear array focused at 3 cm 29 Figure C.2 Reproducibility result for two i
21、ndependent sets of 70 images with a mean number of low-echo sphere centres that is about 15 per 5 mm-depth interval 30 Figure C.3 Results obtained by using both sets of 70 independent images corresponding to Figure C.2 30 Figure C.4 Sector image (curved array) at 4,5 MHz with multiple foci at 4 cm,
22、8 cm and 12 cm depths; the low-echo spheres are 3,2 mm in diameter . 31 Figure C.5 Reproducibility results for a multiple-lateral-focus (4 cm, 8 cm and 12 cm) case corresponding to Figure C.4 . 31 Figure C.6 Reproducibility results for the case corresponding to Figure C.5, except that there is a sin
23、gle focus at 10 cm depth 32 Figure C.7 Reproducibility results for the case corresponding to Figure C.5, except that there is a single focus at 4 cm depth 32 PD IEC/TS 62791:2015 4 IEC TS 62791:2015 IEC 2015 Figure C.8 Image of the phantom containing 2 mm-diameter, low-echo spheres, made with a curv
24、ed array having 1,5 cm radius of curvature, with its focus at 3 cm 33 Figure C.9 Reproducibility results corresponding to Figure C.8 33 Figure C.10 Results using all 100 images in the image set that gave rise to Figure C.9 . 34 Figure C.11 Image of the phantom containing 2 mm-diameter, low-echo sphe
25、res, made with a high-frequency (15 MHz) linear array, laterally focused at 4 cm. 34 Figure C.12 Reproducibility results corresponding to Figure C.11 35 Figure C.13 Results using all 200 images in the image set that gave rise to Figure C.12 35 Figure D.1 End- and top-view diagrams of the phantom con
26、taining 2 mm-diameter, low-echo spheres for use in the 7 MHz to 15 MHz frequency range. 37 Figure D.2 Image obtained by using the phantom containing 2 mm-diameter, low-echo spheres and a pediatric transducer with a radius of curvature of about 1,5 cm . 38 Figure F.1 Average of 10 images obtained by
27、using a phased array . 42 Figure F.2 Plot of the data with blue data computed in the left rectangle in Figure F.1 and red data computed in the right rectangle 42 Figure F.3 Plot of the data when the reflector is on the right side with blue computed in the left rectangle and red computed in the right
28、 rectangle . 43 Figure F.4 The percentage by which the mean pixel values resulting from reflections differ from the mean pixel values not involving reflections . 44 Figure F.5 Wide sector (153), 1 cm-radius-of-curvature transducer with alumina reflector on the left 45 Figure F.6 Plot of the data wit
29、h blue computed in the left rectangle in Figure F.5 and red computed in the right rectangle . 45 Figure F.7 Plot of the data when the reflector is on the right side with blue computed in the left rectangle and red computed in the right rectangle . 46 Figure F.8 The percentage by which the mean pixel
30、 values resulting from reflections differ from the mean pixel values not involving reflections . 46 Figure G.1 Example image of the phantom with a 4,2 MHz curved array and two low-echo spheres per millilitre . 48 Figure G.2 Reproducibility results corresponding to the image set, one of which is show
31、n in Figure G.1 49 Figure H.1 Example of an image from the image set giving rise to the results in Figure H.2; the phantom contained an average of one 4 mm-diameter, low-echo sphere per millilitre . 50 Figure H.2 Results corresponding to an image set, one of which is shown in Figure H.1 51 Figure H.
32、3 Example of an image from the data set giving rise to the results in Figure H.4; the phantom contained an average of two 4 mm-diameter, low-echo spheres per millilitre . 51 Figure H.4 Results corresponding to an image set, one of which is shown in Figure H.3 52 Figure I.1 Example of an image from t
33、he 4 ml1data set producing the results shown in Figure I.2 53 Figure I.2 Results for the phantom containing four 3,2 mm-diameter, low-echo spheres per millilitre 54 Figure I.3 Example of an image from the 2 ml1data set producing the results shown in Figure I.4 54 Figure I.4 Results for the phantom c
34、ontaining two 3,2 mm-diameter, low-echo spheres per millilitre 55 PD IEC/TS 62791:2015IEC TS 62791:2015 IEC 2015 5 Figure I.5 Example of an image from the 1 ml1data set producing the results shown in Figure I.6 55 Figure I.6 Results for the phantom containing one 3,2 mm-diameter, low-echo sphere per
35、 millilitre . 56 Figure J.1 Results for System A scanner and 7CF2 3-D (swept convex array) transducer focused at 4 cm and operated at 4,5 MHz in 2-D mode 57 Figure J.2 Results for System B scanner with a 4DC7-3 3-D (convex array) transducer, operated at 4 MHz in 2-D mode and focused at 4 cm. The sec
36、tor angle and all other console settings mimicked those for the System A case (Figure J.1) . 57 PD IEC/TS 62791:2015 6 IEC TS 62791:2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ULTRASONICS PULSE-ECHO SCANNERS LOW-ECHO SPHERE PHANTOMS AND METHOD FOR PERFORMANCE TESTING OF GRAY-SCALE MEDI
37、CAL ULTRASOUND SCANNERS APPLICABLE TO A BROAD RANGE OF TRANSDUCER TYPES 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 inter
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49、ication to decide whether they can be transformed into International Standards. Technical Specification IEC TS 62791 has been prepared by IEC technical committee 87 Ultrasonics. PD IEC/TS 62791:2015IEC TS 62791:2015 IEC 2015 7 The text of this Technical Specification is based on the following documents: DTS Report on voting 87/554/DTS 87/570/RVC Full information on the voting for the approval of this Technical Specifica
