Are there any standards governing performance of blood pressure instruments?
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. ANSI SP10, sets performance standards for non-automated (aneroid & mercurial) sphygmomanoter as well as automated (electronic) sphygmomanometers.. You may obtain copies of these standards by contacting ANSI here or visit their website.
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