Professional Sphygmomanometers

All medical device manufacturers and most medical devices are regulated by the Food and Drug Administration (FDA). The FDA has accepted the sphygmomanometer standards established by the American National Standards Institute. The ANSI/AAMI/ISO 81060 series of standards set performance requirements for non-automated (aneroid & mercurial) sphygmomanometers as well as automated (electronic) sphygmomanometers. You may obtain copies of these standards by contacting ANSI or visiting their website.