规定了医用电气设备临床研究的要求和方法，该设备用于利用袖带对动脉血压进行间歇性无创自动估计。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。本文件涵盖适用于所有患者群体（即所有年龄和体重范围）的血压计，以及所有使用条件（例如，动态血压监测、压力测试血压监测和用于家庭医疗环境的血压监测）- 测量以及在专业医疗机构中的使用）。

Specifies the requirements and methods for the clinical investigation of medical electrical equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing 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 (i.e. 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).