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PD IEC TS 62736:2023 Ultrasonics. Pulse-echo scanners. Simple methods for periodic testing to verify stability of an imaging system\\\'s elementary performance, 2023
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- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Symbols and abbreviated terms [Go to Page]
- 4.1 Symbols
- Tables [Go to Page]
- Table 1 – Overview to the symbols and definitions of the QA terms, other than those for the display
- 4.2 Abbreviated terms
- Table 2 – Overview of the symbols and definitions of the display QA terms
- 5 General recommendation
- 6 Environmental conditions [Go to Page]
- Table 3 – Abbreviated terms
- 7 Quality assurance levels [Go to Page]
- 7.1 General
- Table 4 – Outline of tests by level
- 7.2 Level 1 tests
- 7.3 Level 2 tests
- 7.4 Level 3 tests
- 8 Equipment and data required [Go to Page]
- 8.1 Phantoms and software [Go to Page]
- 8.1.1 General
- 8.1.2 Phantoms for Level 2 and Level 3 quality assurance
- 8.1.3 Additional phantom specifications for Level 2 quality assurance
- 8.1.4 Additional phantom specifications for Level 3 quality assurance and optional Level 2 tests
- 8.2 Image data [Go to Page]
- 8.2.1 Digital-image data
- 8.2.2 Image-archiving systems
- 8.3 Expectations of system suppliers
- 9 Level 1 test methods
- 10 Level 2 measurement methods [Go to Page]
- 10.1 Mechanical inspection
- 10.2 Image uniformity for transducer element and channel integrity [Go to Page]
- 10.2.1 General
- 10.2.2 Apparatus scanning procedures and system settings
- 10.2.3 Image acquisition
- 10.2.4 Analysis
- 10.3 Randomly distributed high-contrast sphere visualization [Go to Page]
- 10.3.1 Methodology
- Figures [Go to Page]
- Figure 1 – Median-averaged image (right) and its lateral profile (left)
- Figure 2 – Examples of portable apparatus for moving the transducer: a) and c) in equal, chosen increments or b) at a known rate [Go to Page]
- 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
- 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) [Go to Page]
- 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 [Go to Page]
- 11.1 General
- 11.2 Maximum relative depth of penetration [Go to Page]
- 11.2.1 Assessment
- 11.2.2 Scanning system settings
- 11.2.3 Image acquisition
- Figure 5 – Maximum relative depth of penetration – image acquisition [Go to Page]
- 11.2.4 Analysis
- 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))
- 11.3 System-image display [Go to Page]
- 11.3.1 General
- 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] [Go to Page]
- 11.3.3 Level 2 and Level 3 display tests
- Figure 8 – Examples of TG18-LN luminance patterns for luminance measurements [21]
- 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
- 11.4 Distance and other spatial measurements [Go to Page]
- 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
- Annexes [Go to Page]
- 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
- Figure A.2 – Example compact phantom for image uniformity tests
- 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]
- Figure A.4 – Two temporally stable, inexpensive phantoms for image uniformity tests
- Annex B (informative) Available analysis software [Go to Page]
- B.1 Open source software for assessment or tracking of ultrasound image QA data
- Figure B.1 – Example of data analysis for the transducer evaluated to generate Figure 1 [Go to Page]
- B.2 Example of QA control chart
- Table B.1 – Output of image uniformity analysis
- 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)
- Annex C (informative) Electronic test methods and test methods provided by the manufacturers – Relation to clinical significance
- Annex D (informative) Special considerations for 3D imaging transducers [Go to Page]
- 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
- Annex E (informative) Example workbook database for tracking high-contrast, low-echo sphere visibility and luminance of the display
- Table E.1 – Transducer record and baseline high-contrast, low-echo-sphere visualization test data
- Table E.2 – Database of periodic sphere visualization results
- Table E.3 – Completed short QA data entry example form for monitor luminance evaluation using test pattern – QA18
- Table E.4 – Blank, short QA data entry evaluation form for monitor luminance using test pattern – QA18
- Table E.5 – Analysis of luminance measurements
- 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)
- Bibliography [Go to Page]
