ISO/TS 81060-5:2020 无创血压计 第5部分：自动无创血压计测试用NIBP模拟器的重复性和再现性要求
标准编号：ISO/TS 81060-5:2020
中文名称：无创血压计 第5部分：自动无创血压计测试用NIBP模拟器的重复性和再现性要求
英文名称：Non-invasive sphygmomanometers — Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
发布日期：2020-02
标准范围
本文件规定了非侵入性血压（NIBP）模拟器的重复性和再现性要求，该模拟器旨在仅使用非连续示波法测试自动血压计。此外，还对NIBP模拟器上设定的脉率进行了测试。本文件无意将NIBP模拟器产生的信号与附在人体上的袖带中记录的示波信号联系起来。它不打算测试NIBP模拟器和被测自动血压计之间的相互作用（例如，NIBP模拟器的设定值和被测自动血压计的显示值的一致性或袖带和管路的特性，如设计或弹性特性）。注1这些参数可以在临床研究中单独测试，也可以使用不同的特殊测试装置。本文件不检查NIBP模拟器是否能够测试示波式自动血压计绝对血压值的准确性。注2通常根据ISO 81060-2或其他方案通过临床研究进行检测。本文件适用于测试成人、儿童和新生儿上臂、大腿等部位的自动血压计的NIBP模拟器。以及在手腕处测量的自动血压计。
This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.In addition, the pulse rate set on the NIBP simulator is tested.This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties).NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups.This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers.NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.
标准预览图
