【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】:BSENISO14155-1-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2010-01-31
【实施或试行日期】:2010-01-31
【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】:临床调查;临床试验;控制图;定义;牙科设备;牙科器械;文献工作;效率;企业;评定;人体;植入物(外科);信息;检验师;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;人;性能测试;报告;结果;安全;规范(验收);外科植入物;外科器械;监督(认可);系统论;被试人群;测试;试验;利用
【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】:C37
【国际标准分类号】:11_100_20
【页数】:32P.;A4
【正文语种】:英语


【英文标准名称】:Boilingplates(D)ofskirtedandterminals
【原文标准名称】:电灶盘.带溢流边并用接线柱连接的电灶盘D
【标准号】:DIN44910-4-1970
【标准状态】:作废
【国别】:德国
【发布日期】:1970-07
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:加热铁板;设计;家用的;材料;炊具餐具;接线端;灶具;炉圈;炉灶;炊用炉
【英文主题词】:materials;hotplates;ranges;cookerrings;cookers;domestic;design;electricterminals;household;cookingappliances;cateringequipment
【摘要】:
【中国标准分类号】:Y63
【国际标准分类号】:97_040_20
【页数】:2P;A4
【正文语种】:德语