Non-invasive sphygmomanometers-Clinical investigation of intermittent automated measurement type
无创血压计
发布日期:
2020-09-18
本文件规定了医用电气设备临床研究的要求和方法,医用电气设备用于利用袖带间歇性无创自动估计动脉血压。
本文件适用于所有感知或显示脉动、流量或声音以估计、显示或记录血压的血压计。这些血压计不需要自动袖带充气。
本文件涵盖了适用于所有患者群体(如所有年龄和体重范围)的血压计,以及所有使用条件(如动态血压监测、压力测试血压监测、家庭医疗环境中用于自我测量的血压监测仪,以及在专业医疗设施中使用的血压监测仪)。
包含以下内容:BS EN ISO 81060-2:2019
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