UNE-EN IEC 80601-2-30:2019

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofAUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means ofan inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSUREwithout arterial puncture.NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture doesnot directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE forthis ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of aDETERMINATION.This standard covers electrically-powered intermittent, indirect measurement of the BLOODPRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimatingBLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.Requirements for indirect estimation of the BLOOD PRESSURE without arterial punctureME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used inconjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE(NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1. [1]2)If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1.NOTE 2 See also 4.2 of the general standard.