1、Ultrasonics Pulse-echo scanners Simple methods for periodic testing to verify stability of an imaging systemselementary performancePD IEC/TS 62736:2016BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis Published Document is the UK implementation of
2、 IEC/TS 62736:2016.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.
3、Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 76290 1ICS 17.140.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authorit
4、y of theStandards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD IEC/TS 62736:2016IEC TS 62736 Edition 1.0 2016-07 TECHNICAL SPECIFICATION Ultrasonics Pulse-echo scanners Simple methods for periodic testing to verify
5、 stability of an imaging systems elementary performance INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 17.140.50 ISBN 978-2-8322-3529-4 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colourins
6、idePD IEC/TS 62736:2016 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 tes
7、ts . 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.
8、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 scann
9、ing 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 1
10、0.2.5 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 syst
11、em settings 25 PD IEC/TS 62736:2016IEC TS 62736:2016 IEC 2016 3 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
12、 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 Figur
13、e 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 t
14、he 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 (A(j) . 22 Figure A.1 Example phantom for image-uniformity and/or maximum-relative-depth-of-penetration tests . 26 Figure A.2 Example compa
15、ct 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 mat
16、erial 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
17、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 e
18、valuation: 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 an
19、alysis 31 PD IEC/TS 62736:2016 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 systems elementary performance FOREWORD 1) The International Electrotechnical Commission (IEC)
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29、her IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be th
30、e subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. In exceptional circumstances, a technical committee may propose the publication of a Technical Specification w
31、hen the required support cannot be obtained for the publication of an International Standard, despite repeated efforts, or the subject is still under technical development or where, for any other reason, there is the future but no immediate possibility of an agreement on an International Standard. T
32、echnical Specifications are subject to review within three years of publication to decide whether they can be transformed into International Standards. IEC TS 62736, which is a Technical Specification, has been prepared by IEC technical committee 87: Ultrasonics. PD IEC/TS 62736:2016IEC TS 62736:201
33、6 IEC 2016 5 The text of this Technical Specification is based on the following documents: Enquiry draft Report on voting 87/576/DTS 87/592A/RVC Full information on the voting for the approval of this Technical Specification can be found in the report on voting indicated in the above table. This pub
34、lication has been drafted in accordance with the ISO/IEC Directives, Part 2. Terms in bold in the text are defined in Clause 3. Symbols and formulae are in Times New Roman italic. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated
35、 on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be transformed into an International Standard, reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issue
36、d at a later date. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer. PD IEC/TS 62736:2016 6 IEC
37、TS 62736:2016 IEC 2016 INTRODUCTION An ultrasonic pulse-echo scanner produces images of tissue in a scan plane by sweeping a narrow pulsed beam of ultrasound through the section of interest and detecting the echoes generated by reflection at tissue boundaries and by scattering within tissues. Variou
38、s transducer types are employed to operate in a transmit/receive mode to generate/detect the ultrasonic signals. Ultrasonic scanners are widely used in medical practice to produce images of soft-tissue organs throughout the human body. As ultrasound systems are usually employed under rigorous time r
39、estrictions and in diverse environments to help make decisions often critical to patients well being, it is important that the systems perform consistently at the level provided and accepted in initial tests, e.g. those of IEC 61391-1 and IEC 61391-2. This document provides methods to verify the sta
40、bility of an imaging systems elementary performance. This document is deemed necessary because substandard ultrasound system performance is often accepted, or remains undetected in the absence of unequivocal and documented tests. The most common of the failures, in all but the oldest systems nearing
41、 retirement, are subperformance of a transducer-array element or lens or of a cable or electronic channel. Sensitive image uniformity tests for these transducer- and channel-failures are presented in this document for use monthly (Level 1), biannually (Level 2) and biennially (Level 3). With approxi
42、mately 14 % transducer-failure rate and 10 % system-failure rate per year on first testing 1,2,3,4,5,6,7,8,9,10,11,12, there are, very approximately, 100 000 systems worldwide routinely performing suboptimal diagnostic exams for part of the year. This common occurrence of suboptimal diagnostic exami
43、nations has created an urgent need to standardize quality-control (QC) and performance-evaluation procedures to promote improved efficacy of diagnostic examinations through widespread use of effective QC procedures and to dispel myths as to their utility. Proposers believe, however, that existing na
44、tional standards and guides 13,14 specify too many tests and inappropriate tests for detecting and discriminating the common flaws in diagnostic ultrasound systems during routine QC. These practices include tests, such as spatial resolution, which are low-yield and belong in performance-evaluation p
45、rocedures, rather than QC. Modern flat-panel display technology is more stable than, and generally far superior to, earlier CRT displays. However, LCD displays can still exhibit luminance drift, as well as problems such as defective pixels. It is still necessary to evaluate them periodically. PD IEC
46、/TS 62736:2016IEC TS 62736:2016 IEC 2016 7 ULTRASONICS PULSE-ECHO SCANNERS Simple methods for periodic testing to verify stability of an imaging systems elementary performance 1 Scope This document specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasoun
47、d systems with linear array, curved linear array, single element, annular array, phased array, matrix linear array transducers and two-dimensional arrays. Image interpretation and measurement workstations are included. Usually, “periodic testing” is referred to here as “quality control”. This docume
48、nt represents a minimum set of such tests intended for frequent users of medical ultrasound systems, for quality control professionals in their organization, or those hired from other quality-control and/or service-provider organizations. System-manufacturing and repair companies might well employ o
49、ther or additional tests. The tests are defined in three levels, with the simplest and most cost-effective performed most frequently, similarly to 1. More complete tests for acceptance testing and for assessment at times of particular importance or concern are specified in IEC 61391-1, IEC 61391-2 and IEC TS 62791 15. These more complete tests are categorized as performance evaluation, rather than quality control or frequ
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