ISO 81060-1-2007 非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法
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【英文标准名称】:Non-invasivesphygmomanometers-Part1:Requirementsandtestmethodsfornon-automatedmeasurementtype
【原文标准名称】:非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法
【标准号】:ISO81060-1-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-12-01
【实施或试行日期】:2007-12-01
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:血压;血压计;临床研究;定义;诊断设备;电气安全;设备安全;适用性;识别;作标记;测量;测量精度;测量仪器;医疗设备;医学科学;医疗技术学;精密度;安全;规范(验收);血压表;材料强度;技术文献;测试
【英文主题词】:Bloodpressure;Bloodpressuremeter;Clinicalinvestigations;Definitions;Diagnosticequipment;Electricalsafety;Equipmentsafety;Fitnessforpurpose;Identification;Marking;Measurement;Measuringaccuracy;Measuringinstruments;Medicalequipment;Medicalsciences;Medicaltechnology;Precision;Safety;Specification(approval);Sphygmomanometers;Strengthofmaterials;Technicaldocuments;Testing
【摘要】:ThispartofISO81060specifiesrequirementsfornon-automatedsphygmomanometers,asdefinedin3.11,andtheiraccessories,which,bymeansofinflatablecuffs,areusedforthenon-invasivebloodpressuremeasurementbyoperatorobservation.ThispartofISO81060specifiesrequirementsforthesafetyandessentialperformance,includingeffectivenessandlabelling,fornon-automatedsphygmomanometersandtheiraccessories,includingtestmethodstodeterminetheaccuracyofnon-invasivebloodpressuremeasurement.ThepartofISO81060coversnon-invasivebloodpressuremeasurementdeviceswithapressure-sensingelementanddisplayusedinconjunctionwithmeansofdetectingbloodflow.EXAMPLE1AstethoscopefordetectingKorotkoffsounds,Dopplerultrasoundorothermanualmethods.Requirementsfornon-invasivebloodpressuremeasurementequipmentwithelectrically-poweredpressuresensingelementsand/ordisplaysusedinconjunctionwithotherautomaticmethodsdeterminingbloodpressurearespecifiedinIEC60601-2-30[7].RequirementsforinvasivebloodpressuremeasurementequipmentthatdirectlymeasurebloodpressurearespecifiedindocumentIEC60601-2-34[8].EXAMPLE2Measuringequipment,includingassociatedtransducers,thatisusedfortheinvasivemeasurementofcirculatorysystempressures.
【中国标准分类号】:C38
【国际标准分类号】:11_040_10
【页数】:44P.;A4
【正文语种】:英语
【原文标准名称】:非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法
【标准号】:ISO81060-1-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-12-01
【实施或试行日期】:2007-12-01
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:血压;血压计;临床研究;定义;诊断设备;电气安全;设备安全;适用性;识别;作标记;测量;测量精度;测量仪器;医疗设备;医学科学;医疗技术学;精密度;安全;规范(验收);血压表;材料强度;技术文献;测试
【英文主题词】:Bloodpressure;Bloodpressuremeter;Clinicalinvestigations;Definitions;Diagnosticequipment;Electricalsafety;Equipmentsafety;Fitnessforpurpose;Identification;Marking;Measurement;Measuringaccuracy;Measuringinstruments;Medicalequipment;Medicalsciences;Medicaltechnology;Precision;Safety;Specification(approval);Sphygmomanometers;Strengthofmaterials;Technicaldocuments;Testing
【摘要】:ThispartofISO81060specifiesrequirementsfornon-automatedsphygmomanometers,asdefinedin3.11,andtheiraccessories,which,bymeansofinflatablecuffs,areusedforthenon-invasivebloodpressuremeasurementbyoperatorobservation.ThispartofISO81060specifiesrequirementsforthesafetyandessentialperformance,includingeffectivenessandlabelling,fornon-automatedsphygmomanometersandtheiraccessories,includingtestmethodstodeterminetheaccuracyofnon-invasivebloodpressuremeasurement.ThepartofISO81060coversnon-invasivebloodpressuremeasurementdeviceswithapressure-sensingelementanddisplayusedinconjunctionwithmeansofdetectingbloodflow.EXAMPLE1AstethoscopefordetectingKorotkoffsounds,Dopplerultrasoundorothermanualmethods.Requirementsfornon-invasivebloodpressuremeasurementequipmentwithelectrically-poweredpressuresensingelementsand/ordisplaysusedinconjunctionwithotherautomaticmethodsdeterminingbloodpressurearespecifiedinIEC60601-2-30[7].RequirementsforinvasivebloodpressuremeasurementequipmentthatdirectlymeasurebloodpressurearespecifiedindocumentIEC60601-2-34[8].EXAMPLE2Measuringequipment,includingassociatedtransducers,thatisusedfortheinvasivemeasurementofcirculatorysystempressures.
【中国标准分类号】:C38
【国际标准分类号】:11_040_10
【页数】:44P.;A4
【正文语种】:英语
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