This document specifies the requirements and methods for the CLINICAL INVESTIGATION 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 facility).

Incorporates the following:
BS EN ISO 81060-2:2019