Related Guidance Documents
For more information about ultrasonic bioeffects and related topics, see the
following:
• "Bioeffects and Safety of Diagnostic Ultrasound." AIUM Report, January 28,
1993.
• "American Institute of Ultrasound in Medicine Bioeffects Consensus Report."
Journal of Ultrasound in Medicine, Vol. 27, Issue 4, April 2008.
• Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment. (AIUM, NEMA, 2004)
• Second Edition of the AIUM Medical Ultrasound Safety brochure, 2009. (A
copy of this document is provided with each system.)
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers. FDA, September 2008.
• Standard for Real-Time Display of Thermal and Mechanical Acoustic Output
Indices on Diagnostic Ultrasound Equipment. (AIUM, NEMA, 2004)
• 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, Supplement 1.
Acoustic Output and Measurement
Since the initial use of diagnostic ultrasound, the possible human bioeffects from
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 ("Bioeffects
Considerations for the Safety of Diagnostic Ultrasound." Journal of Ultrasound in
Medicine, Vol. 7, No. 9 Supplement, September 1988), 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 January 28, 1993, provides more-current information.
The acoustic output for this system has been measured and calculated in
accordance with the “Acoustic Output Measurement Standard for Diagnostic
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iU22 User Manual
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Safety
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