Chapter 2. Safety 2 – 29
2.5.1.11. Related Guidance Documents
For more information about ultrasonic bioeffects and related topics, refer to the following;
• Medical Ultrasound Safety (AIUM, 2014).
• AIUM Consensus Report on Potential Bioeffects of Diagnostic Ultrasound: Executive
Summary, J. Ultrasound in Medicine, 2008, Vol. 27, Num. 4.
• WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and
Recommendations on Thermal and Non-thermal Mechanisms for Biological Effects.
Ultrasound in Med. & Biol; 1998, 24: Supplement 1.
• Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993)
• Guidelines for the safe use of diagnostic ultrasound equipment. (BMUS, 2009)
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers (U.S. FDA - 2008)
• Particular requirements for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment. (IEC, 2007)
• Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 2008)
• Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment. (IEC, 2007)
• Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On
Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004)
• Ultrasonics - Field characterization -Test methods for the determination of thermal and
mechanical indices related to medical diagnostic ultrasonic fields (IEC, 2005)
• Measurement and Characterization of Medical Ultrasonic Fields up to 40 MHz. (IEC, 2007)
• Ultrasonics-Power Measurements- Radiation Force Balances and Performance
Requirements. (IEC, 2006)
• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM/NEMA,
2004).
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