无创血压计 第2部分：间歇性自动测量型的临床研究

[中文适用范围]： 本文件规定了使用袖带间歇性无创自动估计动脉血压的医疗器械临床研究的要求和方法。 本文件适用于所有感应或显示脉动、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给袖带充气。 本文件涵盖了适用于所有患者群体（例如所有年龄和体重范围）和所有使用条件（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自我测量的血压监测仪）的血压计以及在专业医疗机构中使用）。 示例 IEC 80601-2-30 中给出的自动血压计正在根据本文件进行临床研究。 本文件规定了根据本文件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 中规定的非自动血压计或 IEC 60601-2-34 中规定的有创血压监测设备的临床研究。 [外文原描述]： 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.