【英文标准名称】:Implantsforsurgery-Cardiacpacemakers-Reportingofclinicalperformanceofpopulationsofpulsegeneratorsorleads
【原文标准名称】:外科植入物.心脏起搏器.对使用脉冲发生器或导线的人群的临床使用报告
【标准号】:BSISO5841-2-2001
【标准状态】:现行
【国别】:英国
【发布日期】:2001-02-15
【实施或试行日期】:2001-02-15
【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】:起搏器;脉冲发生器;临床试验;修复术;心脏病学;人工器官;修复装置;心脏;外科植入物;可靠度;分类系统;统计方法分析;报告;统计数据;性能;寿命;医用电气设备
【英文主题词】:Cardiology;Datarepresentation;Electricalmedicalequipment;Implants(surgical);Medicalequipment;Medicalsciences;Pacemakers;Reports;Utilization
【摘要】:ThispartofISO5841specifiesrequirementsforreportsontheclinicalperformanceinhumansofpopulationsamplesofpulsegeneratorsorleads,intendedforlong-termimplantationascardiacpacemakers,hereinafterreferredtoasdevices.Itincludesgeneralrequirementsforallreportsandsupplementaryrequirementsforreportsoncumulativeexperiencewithdevicesandestimatesoffutureclinicalperformancefordevices,whenappropriate.AnnexAprovidesrequirementsforcategorizingdevices.AnnexBprovidesguidelinesforstatistics,includingadiscussionofapplicationoftheresultsobtained.Aswithotherstatisticalmethods,thebenefitoftheanalyticalmethodsinthispartofISO5841islimitedbythesizeofpopulationunderconsideration.AnnexCgivestherationaleforthispartofISO5841.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:28P;A4
【正文语种】:英语