Diagnostic Ultrasound
Acoustic Output Measurement
Testing Services
We offer acoustic output measurement services in Autoscanning and/or non-Autoscanning imaging modes and provide test reports to use in 510(k) submissions to the FDA or international Regulatory Bodies. Sigma Scientific Services is an A2LA and FDA accredited medical safety and performance test laboratory. We specialize in acoustic test methods and FDA ultrasound guidance to assess safety and effectiveness in diagnostic ultrasound systems and transducers.
Test Methods
Acoustic output measurement of diagnostic ultrasound systems and transducers following the IEC 62359, the IEC 62127-1 and the IEC 60601-2-37 test standards as well as the FDA ultrasound guidance for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. We assess acoustic intensity and acoustic power levels using membrane and needle hydrophones as well as radiation force balances.
Test Reporting
Test report include maximum acoustic field variables, statistical and uncertainty analysis, a description of the measurement system, and the description of the measurement process,. Variables include Zsp, Center Frequency, Spatial Peak Pulse Average Intensity (Isppa), Spatial Peak Temporal Average Intensity (Ispta), Pulse Duration, Rarefactional Pressure, ]and Thermal Indexes, among others.