DIN EN ISO 14155-1-2009 人体适用的医疗设备的临床调查.第1部分:一般要求(ISO14155-1:2003)ENISO14155-1:2009的德文版本
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【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects-Part1:Generalrequirements(ISO14155-1:2003);EnglishversionofDINENISO14155-1:2009-11
【原文标准名称】:人体适用的医疗设备的临床调查.第1部分:一般要求(ISO14155-1:2003)ENISO14155-1:2009的德文版本
【标准号】:DINENISO14155-1-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-11
【实施或试行日期】:2009-11-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Clinicalinvestigations;Clinicaltesting;Controlcharts;Definitions;Dentalequipment;Dentalinstruments;Documentations;Efficiency;Enterprises;Evaluations;Humanbody;Implants(surgical);Information;Inspectors;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;People;Performancetesting;Reports;Results;Safety;Specification(approval);Surgicalimplants;Surgicalinstruments;Surveillance(approval);Systemology;Testpersons;Testing;Trials;Utilization
【摘要】:ThispartofISO14155definesproceduresfortheconductandperformanceofclinicalinvestigationsofmedicaldevices.Itspecifiesgeneralrequirementsintendedtoprotecthumansubjects,ensurethescientificconductoftheclinicalinvestigation,-assistsponsors,monitors,investigators,ethicscommittees,regulatoryauthoritiesandbodiesinvolvedintheconformityassessmentofmedicaldevices.ThispartofISO14155a)specifiesrequirementsfortheconductofaclinicalinvestigationsuchthatitestablishestheperformanceofthemedicaldeviceduringtheclinicalinvestigationintendedtomimicnormalclinicaluse,revealsadverseeventsundernormalconditionsofuse,andpermitsassessmentoftheacceptableriskshavingregardtotheintendedperformanceofthemedicaldevice,b)specifiesrequirementsfortheorganization,conduct,monitoring,datacollectionanddocumentationoftheclinicalinvestigationofamedicaldevice,c)isapplicabletoallclinicalinvestigation(s)ofmedicaldeviceswhoseclinicalperformanceandsafetyisbeingassessedinhumansubjects.ThispartofISO14155isnotapplicabletoinvitrodiagnosticmedicaldevices.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:30P.;A4
【正文语种】:英语
【原文标准名称】:人体适用的医疗设备的临床调查.第1部分:一般要求(ISO14155-1:2003)ENISO14155-1:2009的德文版本
【标准号】:DINENISO14155-1-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-11
【实施或试行日期】:2009-11-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Clinicalinvestigations;Clinicaltesting;Controlcharts;Definitions;Dentalequipment;Dentalinstruments;Documentations;Efficiency;Enterprises;Evaluations;Humanbody;Implants(surgical);Information;Inspectors;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;People;Performancetesting;Reports;Results;Safety;Specification(approval);Surgicalimplants;Surgicalinstruments;Surveillance(approval);Systemology;Testpersons;Testing;Trials;Utilization
【摘要】:ThispartofISO14155definesproceduresfortheconductandperformanceofclinicalinvestigationsofmedicaldevices.Itspecifiesgeneralrequirementsintendedtoprotecthumansubjects,ensurethescientificconductoftheclinicalinvestigation,-assistsponsors,monitors,investigators,ethicscommittees,regulatoryauthoritiesandbodiesinvolvedintheconformityassessmentofmedicaldevices.ThispartofISO14155a)specifiesrequirementsfortheconductofaclinicalinvestigationsuchthatitestablishestheperformanceofthemedicaldeviceduringtheclinicalinvestigationintendedtomimicnormalclinicaluse,revealsadverseeventsundernormalconditionsofuse,andpermitsassessmentoftheacceptableriskshavingregardtotheintendedperformanceofthemedicaldevice,b)specifiesrequirementsfortheorganization,conduct,monitoring,datacollectionanddocumentationoftheclinicalinvestigationofamedicaldevice,c)isapplicabletoallclinicalinvestigation(s)ofmedicaldeviceswhoseclinicalperformanceandsafetyisbeingassessedinhumansubjects.ThispartofISO14155isnotapplicabletoinvitrodiagnosticmedicaldevices.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:30P.;A4
【正文语种】:英语
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