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BSI PD IEC TS 62736:2023

BSI PD IEC TS 62736:2023

$198.66

Ultrasonics. Pulse-echo scanners. Simple methods for periodic testing to verify stability of an imaging system’s elementary performance

Published By Publication Date Number of Pages
BSI 2023 70
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PDF Catalog

PDF Pages PDF Title
2 undefined
4 Blank Page
5 CONTENTS
8 FOREWORD
10 INTRODUCTION
12 1 Scope
13 2 Normative references
3 Terms and definitions
17 4 Symbols and abbreviated terms
4.1 Symbols
18 Tables
Table 1 – Overview to the symbols and definitions of the QA terms, other than those for the display
19 4.2 Abbreviated terms
Table 2 – Overview of the symbols and definitions of the display QA terms
20 5 General recommendation
6 Environmental conditions
Table 3 – Abbreviated terms
21 7 Quality assurance levels
7.1 General
Table 4 – Outline of tests by level
22 7.2 Level 1 tests
7.3 Level 2 tests
23 7.4 Level 3 tests
8 Equipment and data required
8.1 Phantoms and software
8.1.1 General
8.1.2 Phantoms for Level 2 and Level 3 quality assurance
24 8.1.3 Additional phantom specifications for Level 2 quality assurance
26 8.1.4 Additional phantom specifications for Level 3 quality assurance and optional Level 2 tests
27 8.2 Image data
8.2.1 Digital-image data
28 8.2.2 Image-archiving systems
29 8.3 Expectations of system suppliers
9 Level 1 test methods
30 10 Level 2 measurement methods
10.1 Mechanical inspection
10.2 Image uniformity for transducer element and channel integrity
10.2.1 General
10.2.2 Apparatus scanning procedures and system settings
31 10.2.3 Image acquisition
32 10.2.4 Analysis
33 10.3 Randomly distributed high-contrast sphere visualization
10.3.1 Methodology
Figures
Figure 1 – Median-averaged image (right) and its lateral profile (left)
35 Figure 2 – Examples of portable apparatus for moving the transducer: a) and c) in equal, chosen increments or b) at a known rate
36 10.3.2 Procedure
Figure 3 – Example of visual estimation of the two defined depth zones in which spheres can be detected with two degrees of fidelity and clarity
37 Figure 4 – Additional examples of visual estimation of the depth Zone 1 and Zone 2, each of which represents a certain degree of fidelity and clarity (IEC 62791)
38 10.3.3 Data recording
10.4 Image displays; system and interpretation; maximum relative depth of penetration; spatial resolution
10.5 Distance and other spatial measurements
11 Level 3 measurement methods
11.1 General
39 11.2 Maximum relative depth of penetration
11.2.1 Assessment
11.2.2 Scanning system settings
40 11.2.3 Image acquisition
Figure 5 – Maximum relative depth of penetration – image acquisition
41 11.2.4 Analysis
42 11.2.5 Commentary
Figure 6 – Mean digitized image-data value versus depth for the phantom image data (A(j)) and for the noise-image data (A'(j))
43 11.3 System-image display
11.3.1 General
44 11.3.2 Level 1 tests of the US system and interpretation-station display
Figure 7 – TG18-QA test pattern for visual evaluation testing [21],[33]
45 11.3.3 Level 2 and Level 3 display tests
Figure 8 – Examples of TG18-LN luminance patterns for luminance measurements [21]
47 Figure 9 – TG270-ULN uniformity and luminance test pattern (TG270-ULN8-127 with background 8-bit grey level 127 is shown) [33]
Table 5 – Ultrasound image display QA tests
48 11.4 Distance and other spatial measurements
11.4.1 General
11.4.2 Apparatus and scanning system settings
11.4.3 Image acquisition
11.4.4 Analysis
11.5 Performance in clinical use and evaluation of QA programme
49 Annexes
Annex A (informative) Example phantoms for full coupling with curved arrays, particularly for image uniformity tests
Figure A.1 – Example phantom for image-uniformity andmaximum relative depth of penetration tests
50 Figure A.2 – Example compact phantom for image uniformity tests
51 Figure A.3 – Photograph and drawing of a three-in-one phantom which provides for determination of distance measurement precision and bias, image-uniformity, very-low-echo sphere visualization, and depth of penetration [39]
52 Figure A.4 – Two temporally stable, inexpensive phantoms for image uniformity tests
53 Annex B (informative) Available analysis software
B.1 Open source software for assessment or tracking of ultrasound image QA data
54 Figure B.1 – Example of data analysis for the transducer evaluated to generate Figure 1
55 B.2 Example of QA control chart
Table B.1 – Output of image uniformity analysis
56 Figure B.2 – Control chart for a dip in the middle of the profile for one transducer (TD) model, C9-4 and the specified serial number (S/N)
57 Annex C (informative) Electronic test methods and test methods provided by the manufacturers – Relation to clinical significance
58 Annex D (informative) Special considerations for 3D imaging transducers
D.1 General
D.2 2D transducers and 3D mechanically driven transducers operating in 2D imaging mode
D.3 2D arrays operating in 3D imaging mode for determining LSNRmd values for reconstructed images as a function of depth or distance from the central plane
D.4 Mechanically driven 3D transducers operating in 3D imaging mode
59 Annex E (informative) Example workbook database for tracking high-contrast, low-echo sphere visibility and luminance of the display
60 Table E.1 – Transducer record and baseline high-contrast, low-echo-sphere visualization test data
61 Table E.2 – Database of periodic sphere visualization results
62 Table E.3 – Completed short QA data entry example form for monitor luminance evaluation using test pattern – QA18
63 Table E.4 – Blank, short QA data entry evaluation form for monitor luminance using test pattern – QA18
64 Table E.5 – Analysis of luminance measurements
65 Figure E.1 – Current and previous measurements and trendlines providing luminance at various grey levels, fractional slope of luminance and deviation from DICOM GSDF in ΔJND per grey level (IEC 62563-2)
66 Bibliography

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BSI PD IEC TS 62736:2023
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