ISO/TS 15539-2000 心血管植入物.血管内假体

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【英文标准名称】:Cardiovascularimplants-Endovascularprostheses
【原文标准名称】:心血管植入物.血管内假体
【标准号】:ISO/TS15539-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-10
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:血管假体;规范(验收);包装件;修复装置;作标记;外科植入物;心脏病学;使用说明书;定义;医疗设备
【英文主题词】:vascularprostheses;specification(approval);packages;prostheticdevices;marking;surgicalimplants;cardiology;instructionsforuse;definitions;medicalequipment
【摘要】:1ThisTechnicalSpecificationgivesrecommendations,basedoncurrentmedicalknowledge,forevaluatingtheabilityofanendovasculardevicetomeetspecifiedmedicalsituations.Additionalrecommendationsonpackagingandsterilizationarealsoprovided.ThisTechnicalSpecificationshouldbeconsideredasasupplementtoISO14630,whichspecifiesgeneralrequirementsfortheperformanceofnon-activesurgicalimplants.2ThisTechnicalSpecificationisapplicabletoendovasculardevices,suchasendovascularprostheses,vascularstentsandfiltersusedinthefollowinglocations:a)aorta;b)coronaryarteries;c)supra-aortictrunks(e.g.carotidarteries,vertebralarteries);d)pulmonaryartery;e)visceralarteries(e.g.renal,mesenteric);f)peripheralarteries;g)arterio-venousaccessshunts;h)veins;i)venacava;j)transjugularintrahepaticporto-systemicshunts(TIPSorTIPSS).3ThisTechnicalSpecificationisnotapplicabletovascularoccluders,withtheexceptionofcontra-lateraliliacoccluderswhenusedasanintegralpartofanaorto-uni-iliacdevice.TherequirementsasstatedinISO14630applyforexcludedproducts.4ThisTechnicalSpecificationisnotapplicabletoproceduresanddevicesusedpriortotheintroductionoftheendovasculardevices(definedin3.1through3.4),suchasballoonangioplastydevices.NOTEAnnexesAandBgivestructuredguidelinestotheappropriatetests/studiesandinformationonrequirementstocheckagainstspecificdevice-relatedproblemsduringthedesignofmedicaldevicesandaccessories.AnnexCgivesguidelinestoappropriatetests.AnnexDgivesmedicaldefinitionsforreportableclinicalevents.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:29P.;A4
【正文语种】:英语