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Chapter 1 Safety
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Bioeects and Safety of Diagnostic Ultrasound (AIUM, 1993)
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Guidelines for the safe use of diagnostic ultrasound equipment. (BMUS, 2009)
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Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Transducers (U.S. FDA – 2008)
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Particular requirements for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment. (IEC, 2007)
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Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 2008)
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Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment. (IEC, 2007)
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Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On
Diagnostic Ultrasound Equipment (AIUM / NEMA, 2004)
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Ultrasonics - Field characterization - Test methods for the determination of thermal and
mechanical indices related to medical diagnostic ultrasonic elds (IEC, 2005)
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Measurement and Characterization of Medical Ultrasonic Fields up to 40 MHz. (IEC, 2007)
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Ultrasonics - Power Measurements - Radiation Force Balances and Performance Requirements.
(IEC, 2006)
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Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM / NEMA,
2004)
Acoustic Output and Measurement
Since the rst use of diagnostic ultrasound, the possible human biological eects (bioeects) of
ultrasound exposure have been studied by various scientic and medical institutions. In October
1987, the American Institute of Ultrasound in Medicine(AIUM) ratied a report prepared by
its Bioeects Committee (Bioeects 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 eects of ultrasound exposure. Another report, “Bioeects
and Safety of Diagnostic Ultrasound”, dated January 28, 1993, provides more up-to-date information.
In addition, periodically updated reports on biological eects, results, and guidelines on safe usage
have been published by groups such as WFUMB (World Federation of Ultrasound in Medicine and
Biology), AIUM, and BMUS.
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