Related guidance documents
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers, issued September 9, 2008.
Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM),
1994.
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,
NEMA UD2-2004.
Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound
Equipment, American Institute of Ultrasound in Medicine, 1993.
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment, NEMA UD3-2004.
Guidance on the interpretation of TI and MI to be used to inform the operator, Annex
HH, BS EN 60601-2-37 reprinted at P05699.
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Appendices
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