標準號：ISO 81060-1-2007
中文標準名稱：非侵入式血壓計.第1部分:非自動測量式血壓計的要求和試驗方法
英文標準名稱：Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
標準類型：C38
發(fā)布日期：2007/12/1 12:00:00
實施日期：2007/12/1 12:00:00
中國標準分類號：C38
國際標準分類號：11.040.10
引用標準：ISO 594-1;ISO 594-2;ISO 7010-2003;ISO 10993-1;ISO 14937;ISO 15223-1-2007;IEC 60601-1
適用范圍：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.