What is PD IEC/TS 62736- Pulse-echo scanners about?
PD IEC/TS 62736 is a safety standard on simple methods for periodic testing to verify stability of an imaging system’s elementary performance. PD IEC/TS 62736 specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasound systems with the 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.”
PD IEC/TS 62736 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 specified in PD IEC/TS 62736, are defined in three levels, with the simplest and most cost-effective performed, most frequently..
PD IEC/TS 62736 also defines terms and specifies methods for measuring (for quality maintenance or quality control) the maximum relative depth of penetration of real-time ultrasound B-mode scanners, though this penetration measure is listed as less frequently applied. The types of transducers used with pulse-echo scanners include:
- Mechanical probes
- Electronic phased arrays
- Linear arrays
- Curved arrays
- Two-dimensional arrays
- Three-dimensional scanning probes based on a combination of the above types
Transducers are 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 the 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 the element-test program.
All scanners considered include basic pulse-echo techniques. PD IEC/TS 62736 is applicable for transducers operating in the 1 MHz to 17 MHz frequency range and could be made applicable up to 40 MHz, if the depth of penetration were allowed to be relative, rather than absolute, and phantom stability was verified [15]. Image-uniformity QC is applicable to transducers operating in the 1 MHz to 40 MHz frequency range as the requirements for phantoms are not stringent.
Note 1: 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.
Note 2: 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.
Note 3: 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 MHz.
Who is PD IEC/TS 62736- Pulse-echo scanners for?
PD IEC/TS 62736 on pulse-echo scanners is relevant to:
- Manufacturers of pulse-echo scanners
- Manufacturers of transducers
- Manufacturers of test equipment
- System manufacturers
- Ultrasonic testing authorities
Why should you use PD IEC/TS 62736- Pulse-echo scanners?
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. Ultrasonic scanners are widely used in medical practice to produce images of soft-tissue organs throughout the human body. PD IEC/TS 62736 provides methods to verify the stability of an imaging system’s elementary performance. PD IEC/TS 62736 is deemed necessary because substandard ultrasound system performance is often accepted or remains undetected in the absence of unequivocal and documented tests.
Sensitive image uniformity tests for transducer and channels are presented in PD IEC/TS 62736 for:
- Use monthly (Level 1)
- Biannually (Level 2)
- Biennially (Level 3)
PD IEC/TS 62736 includes tests, such as spatial resolution, which are low-yield and belong in performance-evaluation procedures, rather than QC. Overall, PD IEC/TS 62736 is useful as it specifies tests for detecting the common flaws in diagnostic ultrasound systems during routine QC.
