AAMI SP10-92

Includes Amendment 1 to SP10 (introduced November 1996) Establishes safety and performance requirements for electronic and electromechanical measurement devices that are used with an occluding cuff for the indirect determination of blood pressure. Included within the scope of this standard are devices which sense or display pulsations, flow, or sounds in connection with the electronic measurement, display, or recording of blood pressure. These devices might or might not have an automatic cuff-inflation system. These devices can also include ambulatory blood pressure monitors. Ambulatory blood pressure monitors are portable, lightweight, automated devices worn or carried by the patient that are able to obtain and store the results of repeated determinations of blood pressure and heart rate during activities of ordinary daily living.