Standards Development

Scope

This document specifies the requirement and methods for the clinical performance verification of ME equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.

This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.

This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare environment and emergency medical services environment).

EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical performance verification according to this document.

This document specifies additional disclosure requirements for the accompanying information of sphygmomanometers that conform with this document.

This document is not applicable to the clinical performance verification of a non-automated sphygmomanometer as given in ISO 81060-1:2007 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

This document is not applicable to clinical performance verification of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.