{"id":239074,"date":"2024-10-19T15:37:56","date_gmt":"2024-10-19T15:37:56","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iec-ts-627362016\/"},"modified":"2024-10-25T10:19:40","modified_gmt":"2024-10-25T10:19:40","slug":"bsi-pd-iec-ts-627362016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iec-ts-627362016\/","title":{"rendered":"BSI PD IEC\/TS 62736:2016"},"content":{"rendered":"<p>This document specifies requirements and methods for periodic testing of the quality of diagnostic 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, \u201cperiodic testing\u201d is referred to here as \u201cquality control\u201d. 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 companies 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 <span class=\"std\"> <span class=\"std-ref\">IEC&nbsp;61391\u20111<\/span> <\/span>, <span class=\"std\"> <span class=\"std-ref\">IEC&nbsp;61391\u20112<\/span> <\/span> and <span class=\"std\"> <span class=\"std-ref\">IEC&nbsp;TS&nbsp;62791<\/span> <\/span> <span class=\"xref\">[15]<\/span>. These more complete tests are categorized as performance evaluation, rather than quality control or frequent periodic testing.<\/p>\n<p>This document also defines terms and specifies methods for measuring (for quality maintenance or quality control) the <b>maximum relative depth of penetration<\/b> of real-time ultrasound B-MODE scanners, though this penetration measure is listed as less frequently applied.<\/p>\n<p>Frequent distance-measurement accuracy tests are recommended only for certain classes of position encoding that are not now known to be highly stable and without bias.<\/p>\n<p>The types of transducers used with these scanners include:<\/p>\n<ul>\n<li>\n<p>mechanical probes;<\/p>\n<\/li>\n<li>\n<p>electronic phased arrays;<\/p>\n<\/li>\n<li>\n<p>linear arrays;<\/p>\n<\/li>\n<li>\n<p>curved arrays;<\/p>\n<\/li>\n<li>\n<p>two-dimensional arrays;<\/p>\n<\/li>\n<li>\n<p>three-dimensional scanning probes based on a combination of the above types.<\/p>\n<\/li>\n<\/ul>\n<p>Transducers not readily amenable to transducer-element testing by the simple image-uniformity procedures specified (for example, phased array and 2D-array transducers) are tested only partially by maximum relative depth of penetration. System manufacturers are encouraged to provide pulsing patterns of the transducer elements to allow testing of individual elements or small-enough groups of elements to enable users to detect significant element failure or to provide access to another implemented and explained element-test program. Dedicated Doppler systems are excluded from coverage here as specialized equipment is required to test them. This test equipment can be specific to the intended application of the Doppler system.<\/p>\n<p>All scanners considered include basic pulse-echo techniques. The failures to be detected by the recommended pulse-echo tests also will affect the operation of other modes, such as colour-flow, harmonic-, elasticity- and compound imaging. The test methodology is applicable for transducers operating in the 1&nbsp;MHz to 17&nbsp;MHz frequency range and could be made applicable up to 40&nbsp;MHz, if the depth of penetration were allowed to be relative, rather than absolute, and phantom stability were verified <span class=\"xref\">[15]<\/span>. Image-uniformity QC is applicable to transducers operating in the 1&nbsp;MHz to 40&nbsp;MHz frequency range as the requirements for phantoms are not stringent.<\/p>\n<div class=\"non-normative-note\">\n<div class=\"note-label\">\n  NOTE\n <\/div>\n<p>Phantom manufacturers are encouraged to extend the frequency range to which phantoms are specified to enable relative depth-of-penetration tests of systems operating at fundamental and harmonic frequencies above 17&nbsp;MHz.<\/p>\n<\/div>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>4<b><\/td>\n<td>CONTENTS  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>FOREWORD  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>INTRODUCTION  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1 Scope  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>4 General recommendation  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>5 Environmental conditions <br \/> 6 Quality control levels <br \/> 6.1 General <br \/> 6.2 Level 1 tests <br \/> Tables  <br \/> Table 1 \u2013 Outline of Level 1 tests  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>6.3 Level 2 tests <br \/> 6.4 Level 3 tests <br \/> Table 2 \u2013 Outline of Level 3 tests additional to those in Table 1   <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>7 Equipment and data required <br \/> 7.1 General <br \/> 7.2 Phantoms <br \/> 7.2.1 Phantoms for Level 2 and\/or Level 3 quality control <br \/> 7.2.2 Phantoms for Level 2 quality control only  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>7.2.3 Phantoms for both Level 2 and Level 3 quality control  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>7.3 Image data <br \/> 7.3.1 Digital-image data  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>7.3.2 Image-archiving systems  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>7.4 Expectations of system suppliers <br \/> 8 Level 1 test methods  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>9 Level 2 measurement methods <br \/> 9.1 Mechanical inspection <br \/> 9.2 Image uniformity for transducer element and channel integrity <br \/> 9.2.1 General <br \/> 9.2.2 Apparatus scanning procedures and system settings  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>9.2.3 Image acquisition  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>9.2.4 Analysis <br \/> Figures  <br \/> Figure 1 \u2013 Median-averaged image (right) and its lateral profile (left)  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>10 Level 3 measurement methods <br \/> 10.1 General <br \/> 10.2 Maximum relative depth of penetration <br \/> 10.2.1 Assessment <br \/> 10.2.2 Scanning system settings  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>10.2.3 Image acquisition <br \/> Figure 2 \u2013 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]  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>10.2.4 Analysis <br \/> Figure 3 \u2013 Mean digitized image-data value vs. depth for the phantom image data (A(j)) and for the noise-image data (A\u02b9(j))  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>10.2.5 Commentary <br \/> 10.3 System-image display <br \/> 10.3.1 General <br \/> 10.3.2 Level 1 tests of the US-system and interpretation-station display <br \/> 10.3.3 Level 2 and 3 tests  <\/td>\n<\/tr>\n<tr>\n<td><b>26<b><\/td>\n<td>10.4 Distance measurements for mechanically scanned distances <br \/> 10.4.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>27<b><\/td>\n<td>10.4.2 Apparatus and scanning system settings <br \/> 10.4.3 Image acquisition <br \/> 10.4.4 Analysis  <\/td>\n<\/tr>\n<tr>\n<td><b>28<b><\/td>\n<td>Annex A  (informative)  Example phantoms for image uniformity and\/or maximum relative depth of penetration <br \/> Figure A.1 \u2013 Example phantom for image-uniformity and\/or maximum-relative-depth-of-penetration tests  <\/td>\n<\/tr>\n<tr>\n<td><b>29<b><\/td>\n<td>Figure A.2 \u2013 Example compact phantom for image-uniformity tests <br \/> Figure A.3 \u2013 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]  <\/td>\n<\/tr>\n<tr>\n<td><b>30<b><\/td>\n<td>Figure A.4 \u2013 A compact uniformity phantom of relatively durable rubber material  <\/td>\n<\/tr>\n<tr>\n<td><b>31<b><\/td>\n<td>Annex B  (informative)  Available analysis software <br \/> B.1 Open source software for assessment for QC of ultrasound image uniformity  <\/td>\n<\/tr>\n<tr>\n<td><b>32<b><\/td>\n<td>Figure B.1 \u2013 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  <\/td>\n<\/tr>\n<tr>\n<td><b>33<b><\/td>\n<td>B.2 Example of QC control chart: <br \/> Table B.1 \u2013 Output of analysis  <\/td>\n<\/tr>\n<tr>\n<td><b>34<b><\/td>\n<td>Figure B.2 \u2013 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)  <\/td>\n<\/tr>\n<tr>\n<td><b>35<b><\/td>\n<td>Annex C  (informative)  Display test patterns <br \/> Figure C.1 \u2013 AAPM TG18-UN10 (left) and TG18-UN80 (right) patterns for luminance uniformity, colour uniformity, and angular response evaluations [35]  <\/td>\n<\/tr>\n<tr>\n<td><b>36<b><\/td>\n<td>Figure C.2 \u2013 Example data entry form for visual display evaluation:left for Figure C.1; right for Figure C.3 <br \/> Figure C.3 \u2013 TG18-CT low-contrast test pattern for the evaluation of the luminance response of display systems [35]  <\/td>\n<\/tr>\n<tr>\n<td><b>37<b><\/td>\n<td>Annex D  (informative)  Electronic test methods and test methods provided by the manufacturers; relation to clinical significance  <\/td>\n<\/tr>\n<tr>\n<td><b>38<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Ultrasonics. Pulse-echo scanners. Simple methods for periodic testing to verify stability of an imaging system\u2019s elementary performance<\/b><\/p>\n<table class=\"shortdes-table\" style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2016<\/td>\n<td>42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":239076,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[270,2641],"product_tag":[],"class_list":{"0":"post-239074","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-17-140-50","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/239074","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/239076"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=239074"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=239074"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=239074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}