标准编号：ISO 81060-1:2007
中文名称：无创伤性血压计 第1部分：非自动化测量型的要求和试验方法
英文名称：Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
发布日期：2007-12
标准范围
This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11,and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressuremeasurement by operator observation.This part of ISO 81060 specifies requirements for the safety and essential performance, includingeffectiveness and labelling, for non-automated sphygmomanometers and their accessories, including testmethods to determine the accuracy of non-invasive blood pressure measurement.The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensingelement and display used in conjunction with means of detecting blood flow.EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods.Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressuresensing elements and/or displays used in conjunction with other automatic methods determining bloodpressure are specified in IEC 60601-2-30 [7].Requirements for invasive blood pressure measurement equipment that directly measure blood pressure arespecified in document IEC 60601-2-34 [8].EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement ofcirculatory system pressures.
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