本文件规定了使用袖带间歇性无创自动估测动脉血压的医用电气设备的临床研究要求和方法。本文件适用于所有感应或显示脉搏、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，压力测试血压监测和家庭医疗环境中的血压监测，用于自我测量以及在专业医疗机构中使用）。根据本文件，正在进行临床研究的IEC 80601-2-30中给出的自动血压计示例。本文件规定了根据本文件已通过临床调查的血压计随附文件的附加披露要求。本文件不适用于ISO 81060-1中给出的非自动血压计或IEC 60601-2-34中给出的有创血压监测设备的临床研究。

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). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34. This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.