scope:

General

This standard establishes safety and performance requirements for all sphygmomanometers, whether nonautomated, automated, or electronic, that are used with an occluding cuff for the indirect determination of arterial blood pressure.

Inclusions

Included within the scope of this standard are aneroid, mercury gravity, and electronic sphygmomanometers used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds and with any other type of display.

Also included within the scope of this standard are all devices that sense or display pulsations, flow, or sounds in connection with the measurement, display, or recording of blood pressure. These devices may or may not employ electrical means for measurement and display. These devices might or might not have an automatic cuff inflation. This standard covers neonatal or newborn through adult categories.

Ambulatory blood pressure monitors, which 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, are included in this standard.

NOTE-For an explanation of the need for this standard and the rationale for its provisions, see annex A.

Exclusions

Excluded from the scope of this standard are devices for direct, intra-arterial measurement of blood pressure. The use of automated monitors that measure blood pressure on the finger are not covered in this standard.