Includes amendments.This standard establishes labeling, safety, and performance requirements for sphygmomanometers,including electronic, electromechanical, and nonautomated devices that are used in theindirect measurement of blood pressure. Ambulatory blood pressure monitors, which are portable,lightweight, automated devices worn or carried by the patient that are able to obtain and store theresults of repeated determinations of blood pressure and heart rate during activities of ordinarydaily living, also are included in the scope of this document.