Hypertension, Vol 21, 504-509, Copyright © 1993 by American Heart Association
WB White, AS Berson, C Robbins, MJ Jamieson, LM Prisant, E Roccella and SG Sheps
The Association for the Advancement of Medical Instrumentation develops
voluntary standards for medical devices so that manufacturers might provide
information on their product and basic safety and performance criteria that
should be considered in qualifying the instrument for clinical use.
American national standards are generated through a consensus process by
committees consisting of experts in research, development, and design from
user, industry, and government communities. Draft standards are made
available for public review and may become American national standards
after review by the American National Standards Institute. The first
American national standard for electronic and automated sphygmomanometers
was published in monograph form in 1987. The objective of the revised 1992
standard for electronic and automated sphygmomanometers is to provide
updated labeling, safety, and performance requirements that help ensure
that consumers and health care professionals are supplied with safe,
accurate devices for the indirect measurement of blood pressure, including
ambulatory blood pressure recorders. This standard permits validation of
the automatic or electronic device by comparison with either direct,
intra-arterial blood pressure measurements or the noninvasive
cuff/stethoscope technique, based on Korotkoff sounds identified by
individuals trained in auscultation. This summary report of the 1992
American national standard for automatic sphygmomanometers provides
recommendations for the methods of comparison, statistical analysis of the
data, presentation of the results, and criteria for acceptability. Users,
researchers, and instrument designers should refer to the American national
standard monograph for detailed requirements.
ARTICLES
National standard for measurement of resting and ambulatory blood pressures with automated sphygmomanometers
Section of Hypertension and Vascular Diseases, University of Connecticut School of Medicine, Farmington 06032-3940.
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