ANSI/HL7 V3 ECG, R 1-2004 健康等级7第3版标准:规定研究.带注释的ECG.发行1
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【英文标准名称】:HL7Version3Standard:RegulatedStudies-AnnotatedECG,Release1
【原文标准名称】:健康等级7第3版标准:规定研究.带注释的ECG.发行1
【标准号】:ANSI/HL7V3ECG,R1-2004
【标准状态】:现行
【国别】:美国
【发布日期】:2004
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:应用层;信息系统;医疗信息学;个人保健;公共卫生
【英文主题词】:Applicationlayer;Informationsystems;Medicalinformatics;Personalhealth;Publichealth
【摘要】:Clinicaltrialsoncandidatedrugproductsoftencollectbiologicaldatafromtrialsubjectsaswaveformsoralgorithmicrepresentationsofthosewaveforms.Afterthedatahavebeencollected,derivedmeasurementssuchasQTintervalareusedtodrawconclusionsaboutthesafetyandeffectivenessofthecandidatedrug.Standardsexistfortransmittingthesederiveddataandtheiranalysisresultsfromthetrialsponsortotheregulatoryagencies;butthesesubmissionshavenothistoricallyincludedrepresentationofthewaveforms,orhaveatbestincludedanimageofthedevice-generatedpaperwaveform.Anewrequesttoincludethedigitalwaveform,thealgorithmicrepresentations,andtheannotationsidentifyingtherelevantlandmarks(e.g.QRS-waveonset,T-waveoffset)thatsupportderivedECGmeasurementshasbeenproposedbytheUSFDA.ThisspecificationwillbeusedtopackagesuchannotateddigitalwaveformdataproducedbyanECGanalysissystemfortransmissionfromtrialsponsortoaregulatoryagency.Innocasewouldawaveformrecordingdeviceberequiredtocommunicateitsdirectwaveformreadingsusingthisspecification.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:
【正文语种】:英语
【原文标准名称】:健康等级7第3版标准:规定研究.带注释的ECG.发行1
【标准号】:ANSI/HL7V3ECG,R1-2004
【标准状态】:现行
【国别】:美国
【发布日期】:2004
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:应用层;信息系统;医疗信息学;个人保健;公共卫生
【英文主题词】:Applicationlayer;Informationsystems;Medicalinformatics;Personalhealth;Publichealth
【摘要】:Clinicaltrialsoncandidatedrugproductsoftencollectbiologicaldatafromtrialsubjectsaswaveformsoralgorithmicrepresentationsofthosewaveforms.Afterthedatahavebeencollected,derivedmeasurementssuchasQTintervalareusedtodrawconclusionsaboutthesafetyandeffectivenessofthecandidatedrug.Standardsexistfortransmittingthesederiveddataandtheiranalysisresultsfromthetrialsponsortotheregulatoryagencies;butthesesubmissionshavenothistoricallyincludedrepresentationofthewaveforms,orhaveatbestincludedanimageofthedevice-generatedpaperwaveform.Anewrequesttoincludethedigitalwaveform,thealgorithmicrepresentations,andtheannotationsidentifyingtherelevantlandmarks(e.g.QRS-waveonset,T-waveoffset)thatsupportderivedECGmeasurementshasbeenproposedbytheUSFDA.ThisspecificationwillbeusedtopackagesuchannotateddigitalwaveformdataproducedbyanECGanalysissystemfortransmissionfromtrialsponsortoaregulatoryagency.Innocasewouldawaveformrecordingdeviceberequiredtocommunicateitsdirectwaveformreadingsusingthisspecification.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:
【正文语种】:英语
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