BS EN ISO 14155-1-2003 人用医疗设备的临床调查.一般要求

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【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects-Generalrequirements
【原文标准名称】:人用医疗设备的临床调查.一般要求
【标准号】:BSENISO14155-1-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-03-12
【实施或试行日期】:2003-03-12
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:规范(验收);医疗技术学;外科植入物;外科植入物;安全;文献工作;手术器械;试验;检验师;利用;医疗产品;牙科设备;企业;人;人体;报告;结果;牙科器械;定义;评定;监督(认可);临床试验;医学科学;医疗设备;性能试验;临床调查;效率
【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;Testing;Trials;Utilization
【摘要】:ISO14155-1:2002definesproceduresfortheconductandperformanceofclinicalinvestigationsofmedicaldevices.Itspecifiesgeneralrequirementsintendedto:protecthumansubjects;ensurethescientificconductoftheclinicalinvestigation;assistsponsors,monitors,investigators,ethicscommittees,regulatoryauthoritiesandbodiesinvolvedintheconformityassessmentofmedicaldevices.ISO14155-1:2002specifiesrequirementsfortheconductofaclinicalinvestigationsuchthatitestablishestheperformanceofthemedicaldeviceduringtheclinicalinvestigationintendedtomimicnormalclinicaluse,revealsadverseeventsundernormalconditionsofuse,andpermitsassessmentoftheacceptableriskshavingregardtotheintendedperformanceofthemedicaldevice,specifiesrequirementsfortheorganization,conduct,monitoring,datacollectionanddocumentationoftheclinicalinvestigationofamedicaldevice,isapplicabletoallclinicalinvestigation(s)ofmedicaldeviceswhoseclinicalperformanceandsafetyisbeingassessedinhumansubjects.ISO14155-1:2002isnotapplicabletoinvitrodiagnosticmedicaldevices.
【中国标准分类号】:C05
【国际标准分类号】:11_100_20
【页数】:34P.;A4
【正文语种】:英语