ISO 14155-1-2003 人用医疗设备的临床调查.第1部分:一般要求

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【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects-Part1:Generalrequirements
【原文标准名称】:人用医疗设备的临床调查.第1部分:一般要求
【标准号】:ISO14155-1-2003
【标准状态】:作废
【国别】:国际
【发布日期】:2003-02
【实施或试行日期】:
【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】:报告;结果;牙科器械;牙科设备;试验;利用;企业;医疗技术学;临床调查;评定;性能试验;手术器械;定义;文献工作;医疗设备;医疗产品;人体;临床试验;人;医学科学;规范(验收);监督(认可);效率;检验师;安全;外科植入物;外科植入物
【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.Itspecifiesgeneralrequirementsintendedto—protecthumansubjects,—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】:C30
【国际标准分类号】:11_100_20
【页数】:21P;A4
【正文语种】:英语