抄録
From the viewpoint of safety, it is necessary for the diagnostic ultrasonic equipment used in clinical practice to satisfy the FDA 510 (k) requirement track III. The new requirement requires medical doctors and staff to have a greater understanding of ultrasonic bioeffects as indicated by the mechanical index (MI) and the thermal index (TI), on the real-time display of recently developed diagnostic ultrasonic devices.
This article describes the significance of MI and TI and the variables in clinical use. Also it is noted that the ultrasonic examiner should uphold the principle of ALARA (as low as reasonably achievable) in clinical use.
