G - 6 Operator’s Manual
G Acoustic Output
G.9 References for Acoustic Power and Safety
• “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
• “Medical Ultrasound Safety” issued by AIUM in 1994
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019.
Center for Devices and Radiological Health.
• Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment issued by
IEC in 2015
• IEC 62359, Ultrasonics-Field characterization-Test methods for the determination of thermal
and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
Acoustic Quantities Total Uncertainties (Standard)
Power 26.48% for non-scan modes; 6.03% for scan
modes.
Frequency 0.22%
Pressure 13.01%
Ita 26.48% for non-scan modes; 26.95% for scan
modes.
Ipa 26.5%
Mechanical Index 13.01%
Total Uncertainty for TIS 26.48% for non-scan modes; 6.03% for scan
modes.
Total Uncertainty for TIB 26.48% or 18.72% for non-scan modes; 6.03%
for scan modes.
Total Uncertainty for TIC 26.48% for non-scan modes; 6.03% for scan
modes.