标准摘要
[中文适用范围]: 、使用环境和操作人员的资质提出了明确要求,以确保测量结果的可靠性和一致性。标准适用于所有用于临床测量的自动血压计,包括但不限于电子血压计和基于其他技术原理的设备。 ***此介绍可能不准确,请注意参考原文。 [外文原描述]: ISO 81060-2:2013 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. ISO 81060-2:2013 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. ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use. ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.
英文名称Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type