Ultrasound Transducer Validation and Acoustic Output Testing

Ultrasound Testing
Acoustic Output Measurement

Acoustic Output Testing

The accurate quantitative determination of the spatial and temporal characteristics of ultrasonic fields in diagnostic ultrasound devices is important for safety reasons. The precise determination of acoustic output and other field quantities, and how they vary in time and space, allows manufacturers of diagnostic ultrasound equipment to evaluate if the diagnostic ultrasound system is within the safety margins or FDA preamendment values. As a complement to our engineering compliance activities, Sigma Biomedical has developed a system for measuring those parameters according to the most recent standards of the National Electric Manufactures Association (NEMA) and ISO as well as regulatory agencies such as the US Food and Drug Administration (FDA) The result of this work is the Acoustic Power and Intensity Measurement System.

Acoustic output testing, measurement and reporting follows the IEC 62359 standard (Ultrasonics - Field Characterization - Test Methods For The Determination Of Thermal And Mechanical Indices Related To Medical Diagnostic Ultrasonic Fields), the IEC 60601-2-37 standard (IEC 60601-1 Amendment 1 - Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment) and the FDA guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019.

Sigma Biomedical (Sigma Scientific Services LLC) is an A2LA accredited laboratory under the ISO/IEC 17025 standard for acoustic test methods. Click Here for our accreditation certificate. Sigma Scientific Services is an FDA accredited safety and performance medical device testing laboratory under the ASCA program.

Our offer

We offer a complete acoustic output measurement service. We will carry out acoustic output measurement in autoscanning and/or non-autoscanning modes and provide the test report to use in the 510(k) submission to the FDA Office of Device Evaluation, Center for Devices and Radiological Health, or to the European Medical Device Directive (MDD). Additional measurements include acoustic property measurements of ultrasonic gels such as acoustic attenuation. Typically there is a minimum of 3 transducers per imaging mode that need to be tested for statistical significance. However, the number of transducers might increase depending on how close the reported value is to FDA pre amendment values as increasing the number of measurements reduces the standard deviation and thus the maximum reported value.

Test Report

Test Reports include maximum acoustic field variables, statistical and uncertainty analysis, a description of the measurement system, description of the measurement process, and hydrophone calibration methods. Variables to be reported include Pulse Waveform and Pulse Intensity Integral (PII) Plots, Zsp - Position of the maximum spatial PII. Center Frequency, Spatial Peak Pulse Average Intensity (Isppa), Spatial Peak Temporal Peak Intensity, Spatial Peak Temporal Average Intensity (Ispta), Intensity Maximum (Imax) values, Pulse Duration, In-Water Measured Intensity Values Derated (estimated in situ) Intensity values, Pressure Positive Peak and Pressure Negative Peak values, Acoustic Power, Beam Dimensions. We have provided test reports to agencies in the US (FDA), Canada, Japan, and Europe for diagnostic ultrasound product registration.

3D Beam Simulation

Ultrasonic Fields

2D Beam Measurement

Ultrasonic Fields

Beam Profile

Acoustic Report

Frequency Response

Acoustic Report