Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Abstract
This part of the 80601 International Standard applies to the basic safety and essential performance of utomated sphygmomanometers, hereafter referred to as me equipment, which by means of an inflatable cuff, are used for non-continuous indirect estimation of the blood pressure without arterial puncture. NOTE 1 Equipment that performs indirect determination of the blood pressure without arterial puncture does not directly measure the blood pressure. It only estimates the blood pressure.This document specifies requirements for the basic safety and essential performance for this me equipment and its accessories, including the requirements for the accuracy of blood pressure determination. This document covers automatic electrically-powered me equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment.Requirements for indirect estimation of the blood pressure without arterial puncture me equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO 81060-1 [2].
Begin
2025-01-10
Planned document number
DIN EN IEC 80601-2-30
Project number
02232844
