DIN IEC/TS 62736:2024-05

This Technical Specification contains definitions of terms and specifies methods for measuring the maximum relative penetration depth of real-time ultrasound B-MODE scanners. Frequent distance-measurement accuracy tests are recommended in this document only for certain classes of position encoding that are not now known to be highly stable and without bias. QA in all dimensions is recommended in this document as the first test for such systems. The types of transducers used with these scanners include a) electronic phased arrays, b) linear arrays, c) convex arrays, d) mechanical transducers, e) two-dimensional arrays operated in a 2D imaging mode, f) transducers operating in 3D imaging mode for a limited number of sets of reconstructed 2D images, and g) three-dimensional scanning transducers based on a combination of the above types. The test sets described are intended for users of medical ultrasound systems and for quality control specialists. The procedures described are suitable for diagnostic ultrasound systems (pulse-echo techniques) currently operating from 1 MHz to 40 MHz, although available phantoms meet the specifications only from 1 MHz to 23 MHz. The tests are defined in three levels: Level 1 comprises five quick tests/observations to be performed daily to monthly by those normally operating the systems. - Level 2 includes one necessary test for all systems in addition to those of Level 1, two Level 1 tests performed more rigorously, two tests that are for special situations or equipment, and one that is just optional, included because it is highly developed. Level 2 tests are performed annually by those with meaningful quality assurance training. - Level 3 extends the two special situations tests to all systems, adds one optional test and includes a periodic review of the QA programme. All tests on scanners considered here evaluate basic pulse-echo techniques. Detection errors caused by the recommended pulse echo tests are also likely to detect most errors that impair the operation of other modes, such as color flow, harmonic, elasticity, and compound imaging. The tests are applicable to transducers operating in the frequency range from 1 MHz to 40 MHz, as the requirements for phantoms for this test are not stringent. These more comprehensive tests are categorized as performance evaluation rather than quality control or frequent periodic testing. It is possible that a good automated analysis of the high-contrast sphere tests may reduce both the need for the optional tests listed here and a more complete performance evaluation. A complete evaluation of distance measurement accuracy may still be necessary if automated 3D distance measurement calibration is not added to the high-contrast sphere tests. Manufacturers of phantoms are encouraged to extend the frequency range for which phantoms are specified to enable relative penetration depth testing of systems operating at fundamental and harmonic frequencies above 23 MHz. System manufacturers and repair companies, as well as companies that perform more comprehensive performance evaluations for acceptance, replacement, or research, may well perform other or additional tests that are not within the scope of this Technical Specification. More complete tests than those included in the three stages for regular testing and for evaluation at particularly important or critical times are specified in IEC 61391-1[1], 61391-2[2], and TS 62791 [16]. Uniformity tests of transducers that are not readily accessible for testing transducer elements using the simple image uniformity methods specified here (for example, phased array and 2D array transducers) are not included in this scope. They are normally well evaluated by careful performance of high-contrast sphere tests. System manufacturers are encouraged to provide pulse patterns of the transducer elements to enable testing of individual elements or groups of elements that are small enough to allow users to detect significant element failures, or to provide access to another implemented and explained element test program.