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 testing of 3D-distributions of void-detectability ratio (VDR)

IEC/TS 62558:2011(E) specifies essential 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. Medical diagnostic ultrasound systems and related transducers 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 (Tissue Mimicking Material) phantom is intended to be used to measure and to enable documentation of changes in void-detectability ratio in periodic tests over years of use. This technical specification establishes:
- Important characteristics and 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 test prior to void-detectability ratio (VDR) measurement is recommended.

General Information

• Status: Published
• Publication Date: 22-Mar-2011
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: TC 87 - Ultrasonics
• Drafting Committee: WG 9 - TC 87/WG 9
• Current Stage: PPUB - Publication issued
• Start Date: 30-Apr-2011
• Completion Date: 23-Mar-2011

Standards Content (Sample)

IEC/TS 62558 ®
Edition 1.0 2011-03
TECHNICAL
SPECIFICATION
colour
inside
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)

IEC/TS 62558:2011(E)
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IEC/TS 62558 ®
Edition 1.0 2011-03
TECHNICAL
SPECIFICATION
colour
inside
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)

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
X
ICS 17.140.50 ISBN 978-2-88912-377-3

– 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 . 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 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 (informative) 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
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 – Phantom 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 of B-D-C planes . 28

TS 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 . 31
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
Figure 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) – Autocorrelation 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 test . 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 probe 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

– 4 – TS 62558  IEC:2011(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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)

FOREWORD
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