Acclarix LX9 Series Diagnostic Ultrasound System User Manual
Ultrasound Intensity and Safety
B.7 References for Acoustic Output and Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
2. “Medical Ultrasound Safety” issued by AIUM in 1994
3. IEC 62359:2017, Ultrasonics - Field characterization - Test methods for the determination of
thermal and mechanical indices related to medical diagnostic ultrasonic fields.
4. Guidance for Industry and FDA Staff: Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019 by U.S.
Department of Health and Human Services, Food and Drug Administration.
5. IEC60601-2-37, Medical electrical equipment - Part 2-37:2007+AMD1:2015 Particular
requirements for the basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment, International Electro technical Commission.
6. Roy C. Preston, David R. Bacon, and Robert A. Smith, Calibration of Medical Ultrasonic
Equipment - Procedures and Accuracy Assessment, IEEE Transactions on Ultrasonics,
Ferroelectrics, and Frequency Control, Vol. 35, No. 2, page110, March 1988.
B.8 Transducer Acoustic Output Data
Please refer to the User Manual Advanced Volume(P/N: 01.54.458943) for details acoustic output
data of each transducer.
To Next Page
Loading...
Need help?
General
