BS PD IEC TS 62736-2016 Ultrasonics Pulse-echo scanners Simple methods for periodic testing to verify stability of an imaging system's elementary performance《超声学 脉冲回波扫描仪 验.pdf

1、Ultrasonics Pulse-echo scanners Simple methods for periodic testing to verify stability of an imaging systems elementary performance PD IEC/TS 62736:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementati

2、on of IEC/TS 62736:2016. The UK participation in its preparation was entrusted to Technical Committee EPL/87, Ultrasonics. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a

3、 contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 76290 1 ICS 17.140.50 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published u

4、nder the authority of the Standards Policy and Strategy Committee on 31 July 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TS 62736:2016 IEC TS 62736 Edition 1.0 2016-07 TECHNICAL SPECIFICATION Ultrasonics Pulse-echo scanners Simple methods for per

5、iodic testing to verify 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

6、 distributor. colour inside PD 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 t

7、ests . 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 .

8、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 .

9、 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 .

10、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 Ap

11、paratus and scanning system 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

12、 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 . 3

13、5 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 tr

14、ansducer 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 (A(j) . 22 Figure A.1 Example phantom for image-uniformity and/or maximum-relative-depth- of-penetration tests . 2

15、6 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 rel

16、atively 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 Contr

17、ol 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

18、 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 .

19、 11 Table B.1 Output of analysis 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 Electro

20、technical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To

21、 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC Natio

22、nal Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (I

23、SO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation

24、from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be

25、 held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. An

26、y divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access t

27、o IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individu

28、al experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, thi

29、s IEC Publication or any other 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 thi

30、s IEC Publication may be the 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

31、a Technical Specification when 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 a

32、n International Standard. Technical 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

33、 62736:2016IEC TS 62736:2016 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 i

34、n the above table. This publication 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 t

35、he stability date indicated 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 th

36、is publication may be issued 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.

37、PD IEC/TS 62736:2016 6 IEC 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 scatte

38、ring within tissues. Various 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 emp

39、loyed under rigorous time restrictions 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 provide

40、s methods to verify the stability 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

41、 the oldest systems nearing 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 biennia

42、lly (Level 3). With approximately 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

43、suboptimal diagnostic examinations 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

44、 however, that existing national 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

45、in performance-evaluation procedures, 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 evaluat

46、e them periodically. PD IEC/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 d

47、iagnostic medical ultrasound 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 “qu

48、ality control”. This document 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 co

49、mpanies might well employ other 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