IEC TS 62736:2016

IEC TS 62736 ®
Edition 1.0 2016-07
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Pulse-echo scanners –
Simple methods for periodic testing to verify stability of an imaging system’s
elementary performance
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IEC TS 62736 ®
Edition 1.0 2016-07
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Pulse-echo scanners –

Simple methods for periodic testing to verify stability of an imaging system’s

elementary performance
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-3529-4

– 2 – IEC TS 62736:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references. 8
3 Terms and definitions . 8
4 General recommendation . 9
5 Environmental conditions . 10
6 Quality control levels . 10
6.1 General . 10
6.2 Level 1 tests . 10
6.3 Level 2 tests . 11
6.4 Level 3 tests . 11
7 Equipment and data required . 12
7.1 General . 12
7.2 Phantoms . 12
7.2.1 Phantoms for Level 2 and/or Level 3 quality control . 12
7.2.2 Phantoms for Level 2 quality control only . 12
7.2.3 Phantoms for both Level 2 and Level 3 quality control . 13
7.3 Image data . 14
7.3.1 Digital-image data . 14
7.3.2 Image-archiving systems . 15
7.4 Expectations of system suppliers . 16
8 Level 1 test methods . 16
9 Level 2 measurement methods . 17
9.1 Mechanical inspection . 17
9.2 Image uniformity for transducer element and channel integrity. 17
9.2.1 General . 17
9.2.2 Apparatus scanning procedures and system settings . 17
9.2.3 Image acquisition . 18
9.2.4 Analysis . 19
10 Level 3 measurement methods . 20
10.1 General . 20
10.2 Maximum relative depth of penetration. 20
10.2.1 Assessment . 20
10.2.2 Scanning system settings . 20
10.2.3 Image acquisition . 21
10.2.4 Analysis . 22
10.2.5 Commentary . 23
10.3 System-image display . 23
10.3.1 General . 23
10.3.2 Level 1 tests of the US-system and interpretation-station display . 23
10.3.3 Level 2 and 3 tests . 23
10.4 Distance measurements for mechanically scanned distances . 24
10.4.1 General . 24
10.4.2 Apparatus and scanning system settings . 25

10.4.3 Image acquisition . 25
10.4.4 Analysis . 25
Annex A (informative) Example phantoms for image uniformity and/or maximum
relative depth of penetration . 26
Annex B (informative) Available analysis software . 29
B.1 Open source software for assessment for QC of ultrasound image uniformity . 29
B.2 Example of QC control chart: . 31
Annex C (informative) Display test patterns . 33
Annex D (informative) Electronic test methods and test methods provided by the
manufacturers; relation to clinical significance . 35
Bibliography . 36

Figure 1 – Median-averaged image (right) and its lateral profile (left) . 19
Figure 2 – A) Image of a uniform section in a tissue-mimicking phantom, bright
rectangle; B) Image displaying electronic noise only, obtained with the operating
controls set the same as for A but with the transducer decoupled from the phantom
[SOURCE: University of Wisconsin] . 21
Figure 3 – Mean digitized image-data value vs. depth for the phantom image data (A(j))
and for the noise-image data (Aʹ(j)) . 22
Figure A.1 – Example phantom for image-uniformity and/or maximum-relative-depth-
of-penetration tests . 26
Figure A.2 – Example compact phantom for image-uniformity tests . 27
Figure A.3 – Photograph and drawing of a three-in-one phantom which provides for
determination of distance measurement precision and bias, image uniformity and
depth of penetration [37] . 27
Figure A.4 – A compact uniformity phantom of relatively durable rubber material . 28
Figure B.1 – On the left the profile of median pixel value is plotted for each image
column in the analysis box shown in the median image on the right for the transducer
in Figure 1, but without the nylon filament obstructing some central elements . 30
Figure B.2 – Control chart for a dip in the middle of the profile for one transducer (TD)
mode C9-4 and the specified serial number (S/N) . 32
Figure C.1 – AAPM TG18-UN10 (left) and TG18-UN80 (right) patterns for luminance
uniformity, colour uniformity, and angular response evaluations [35] . 33
Figure C.2 – Example data entry form for visual display evaluation: left for Figure C.1;
right for Figure C.3. 34
Figure C.3 – TG18-CT low-contrast test pattern for the evaluation of the luminance
response of display systems [35] . 34

Table 1 – Outline of Level 1 tests . 10
Table 2 – Outline of Level 3 tests additional to those in Table 1 . 11
Table B.1 – Output of analysis . 31

– 4 – IEC TS 62736:2016 © IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – PULSE-ECHO SCANNERS –

Simple methods for periodic testing to verify stability
of an imaging system’s elementary performance

FOREWORD
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...