Standards Development

Scope

NOTE There is guidance or rationale for this Clause in A.2.1.

This document specifies the requirements and methods for the clinical performance verification of cuffless automated non-invasive sphygmomanometer used for estimating arterial blood pressure providing a single set of blood pressure parameters from a number of heart beats without the need of arterial puncture and without the need of creating an arterial occlusion at each reading.

This document applies to a sphygmomanometer that requires calibration and those that do not require calibration. This document covers a sphygmomanometer intended for use in all patient populations (e.g. all age and weight ranges), and all use environments (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitoring in the home healthcare environment for self-measurement as well as use in a professional healthcare facility). This document specifies additional disclosure requirements for the accompanying documents of a sphygmomanometer that has' conformed with a clinical performance verification according to this document.

This document is not applicable to clinical performance verification of:

—     non-automated sphygmomanometers as given in 0;

—     continuous automated sphygmomanometers as given in 0; and

—     invasive blood pressure monitoring equipment as given in 0.