【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects-Part1:Generalrequirements(ISO14155-1:2003);GermanversionENISO14155-1:2003
【原文标准名称】:医学受验者用医疗设备的临床调查.第1部分:一般要求
【标准号】:DINENISO14155-1-2003
【标准状态】:作废
【国别】:德国
【发布日期】:2003-09
【实施或试行日期】:
【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】:人;牙科器械;结果;利用;牙科设备;文献工作;检验师;临床医学;临床调查;性能试验;医疗设备;试验;规范(验收);医疗产品;外科植入物;外科植入物;医疗技术学;手术器械;评定;定义;安全;效率;企业;临床试验;人体;医学科学;监督(认可);报告
【英文主题词】:Clinicalinvestigations;Clinicalmedicine;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】:ThisInternationalStandarddefinesproceduresfortheconductandperformanceofclinicalinvestigationsofmedicaldevices.Itspecifiesgeneralrequirementsintendedtoprotecthumansubjects;ensurethescientificconductoftheclinicalinvestigation;assistsponsors,monitors,investigators,ethicscommittees,regulatoryauthoritiesandbodiesinvolvedintheconformityassessmentofmedicaldevices.ThisInternationalStandardpertainstoallclinicalinvestigation(s)ofmedicaldeviceswhoseclinicalperformanceandsafetyisbeingassessedinhumansubjects;specifiesrequirementsfortheconductofaclinicalinvestigationsuchthatitdemonstratesthatthemedicaldeviceachievestheperformanceintendedbythemanufacturer,revealsanyadverseeventsundernormalconditionsofuseandpermitassessmentoftheacceptableriskshavingregardtotheintendedperformanceofthemedicaldeviceandspecifiesrequirementsfortheorganization,designincludingmethodology,conduct,monitoring,datacollection,documentationandevaluationofresultsoftheclinicalinvestigationofamedicaldevice.ThisInternationalStandarddoesnotapplytoin-vitrodiagnosticmedicaldevices.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:30P.;A4
【正文语种】:德语