ISO 14155-2011 用于人体的医疗器械临床研究.良好的临床实践

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【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects.Goodclinicalpractice
【原文标准名称】:用于人体的医疗器械临床研究.良好的临床实践
【标准号】:ISO14155-2011
【标准状态】:现行
【国别】:国际
【发布日期】:2011-02-01
【实施或试行日期】:2011-02-01
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【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;Ethics;Evaluations;Humanbody;Implants(surgical);Information;Inspectors;Law;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;People;Performancetesting;Reports;Results;Safety;Specification(approval);Surgicalimplants;Surgicalinstruments;Surveillance(approval);Systemology;Testpersons;Testing;Trials;Utilization
【摘要】:ThisInternationalStandardaddressesgoodclinicalpracticeforthedesign,conduct,recordingandreportingofclinicalinvestigationscarriedoutinhumansubjectstoassessthesafetyorperformanceofmedicaldevicesforregulatorypurposes.TheprinciplessetforthinthisInternationalStandardalsoapplytoallotherclinicalinvestigationsandshouldbefollowedasfaraspossible,consideringthenatureoftheclinicalinvestigationandtherequirementsofnationalregulations.ThisInternationalStandardspecifiesgeneralrequirementsintendedto?protecttherights,safetyandwell-beingofhumansubjects,?ensurethescientificconductoftheclinicalinvestigationandthecredibilityoftheclinicalinvestigationresults,?definetheresponsibilitiesofthesponsorandprincipalinvestigator,and?assistsponsors,investigators,ethicscommittees,regulatoryauthoritiesandotherbodiesinvolvedintheconformityassessmentofmedicaldevices.Itdoesnotapplytoinvitrodiagnosticmedicaldevices.NOTEStandardsdevelopedbyISO/TC194areintendedtobeappliedtomedicaldevices.UsersofthisInternationalStandardwillneedtoconsiderwhetherotherstandardsand/orrequirementsalsoapplytotheinvestigationaldevice(s)underconsideration.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:66P.;A4
【正文语种】:英语