Chapter 1 Safety 1 - 33
use.
▐Related Guidance Documents
For more information about ultrasonic bioeffects and related topics refer to the following:
- AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic Ultrasound”
- Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept.
1998: Vol. 7, No. 9 Supplement
- Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA.
1998)
- Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998)
- Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994. (A copy
of this document is shipped with each system.)
- Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Transducers. FDA. September 1997. FDA.
- Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998)
- WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations
on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in
Medicine and Biology, 1998: Vol. 24, Supplement1.
▐Acoustic Output and Measurement
Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of
ultrasound exposure have been studied by various scientific and medical institutions. In October 1987,
the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects
Committee (Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept.
1988: Vol.7, No.9 Supplement), sometimes referred to as the Stowe Report, which reviewed available
data on possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic
Ultrasound,” dated 28th January, 1993, provides more up to date information.
The acoustic output for this system has been measured and calculated in accordance with the
December 1985 “510 (K) Guide for Measuring and Reporting Acoustic Output of Diagnostic
Ultrasound Medical Devices,” except that the hydrophone meets the requirements of “Acoustic Output
Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992).
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