标准摘要
[中文适用范围]： 本文件规定了非侵入式血压（NIBP）模拟器的要求，这些模拟器用于测试利用振荡法的非连续方法自动工作的示波测量装置。此外，还对NIBP模拟器上的心率进行测试。本文件不旨在将NIBP模拟器产生的信号与记录在人类臂 cuff 上的振荡信号相关联。它不打算测试NIBP模拟器与被测自动示波测压仪之间的相互作用（例如，设置值的对应关系、软管和 cuff 的设计或弹性特性等）。注1：这些参数通常通过临床调查或其他特殊测试装置单独测试。本文件未检查NIBP模拟器是否能够测试振荡法自动示波测压仪绝对血压值的准确性。注2：通常根据 ISO 81060-2 或其他协议进行此测试。本文件适用于测试成人、儿童和早产儿上臂、大腿等处自动示波测压仪的NIBP模拟器，以及在手腕测量的自动示波测压仪。 [外文原描述]： 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.
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