This standard specifies requirements for mechanical sphygmomanometers and their
accessories that, by means of an inflatable cuff, are used for the non-invasive
measurement of blood pressure. This standard also specifies requirements for the
safety, essential performance, effectiveness, and labeling, for these instruments and
their accessories, including test methods to determine the accuracy of their
measurements. The standard covers non-invasive blood pressure measuring devices
with a mechanical pressure sensing element and display used in conjunction with a
stethoscope or other manual methods for detecting Korotkoff sounds.