Who Needs Specification Standards in Medical Ultrasound?

European Communities (EC) Medical Devices Directive (93/42/EEC) (1993) Official Journal of the European Communities; L169 Volume 36: 1–43.

FDA, Food and Drug Administration, Guide for measuring and reporting acoustic output of diagnostic ultrasound medical devices. FDA 510 (K), 1985, US FDA, Rockville, Maryland 20857, USA.

AIUM/NEMA Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. Publication UL-3 1992, American Institute of Ultrasound in Medicine, Rockville, MD.