Acoustic output standard released

September 3, 1992

Discussions among scientists, physicians, regulators and industryrepresentatives have resulted in the publication of the AIUM/NEMAacoustic output standard for ultrasound devices. The document,which covers acoustic parameters as well as mechanical and

Discussions among scientists, physicians, regulators and industryrepresentatives have resulted in the publication of the AIUM/NEMAacoustic output standard for ultrasound devices. The document,which covers acoustic parameters as well as mechanical and thermalindices, is available from the National Electrical ManufacturersAssociation.

The acoustic output standard has been in development since1989, when the Food and Drug Administration suspended power outputlimits on ultrasound equipment. At the same time, the agency requiredthat safety features be established to offset questions of safetyraised by high-output ultrasound machines.

Researchers began asking what output parameters are neededto permit reasonable risk-benefit decisions by average users.

"We must provide information to users in order to maintainsafety, while providing them with the ability to go to higherlevels and potentially obtain better image quality," saidDr. William J. O'Brien, director of the Bioacoustics ResearchLaboratory at the University of Illinois in Urbana.

The newly adopted standard is the result of a collaborativeeffort between the FDA, ultrasound manufacturers and the AmericanInstitute of Ultrasound in Medicine.

The acoustic output standard describes measurement proceduresfor ultrasound output parameters. It defines types of acousticoutput levels and details standard procedures for measuring acousticoutput parameters.

The standard for real-time display of thermal and mechanicaloutput indices on ultrasound units aids users in monitoring acousticoutput while maximizing clinical information.