【英文标准名称】:Cardiovascularimplants-Endovasculardevices-Endovascularprostheses
【原文标准名称】:心血管植入物.血管内设备.血管内假体
【标准号】:BSENISO25539-1-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2003-03-27
【实施或试行日期】:2003-03-27
【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】:验收规范;心脏病学;定义(术语);设计;血管的;英语;使用说明书;作标记;材料;医疗器械;医疗器材;包装件;特性;修复装置;规范(验收);消毒;灭菌;外科植入物;试验;血管假体
【英文主题词】:Acceptancespecification;Cardiology;Definitions;Design;Endovascular;Englishlanguage;Instructionsforuse;Marking;Materials;Medicaldevices;Medicalequipment;Packages;Properties;Prostheticdevices;Specification(approval);Sterile;Sterilization(hygiene);Surgicalimplants;Testing;Vascularprostheses
【摘要】:1.1ThispartofISO25539specifiesrequirementsforendovascularprostheses,baseduponcurrentmedicalknowledge.Withregardtosafety,itgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilizationpackagingandinformationsuppliedbythemanufacturer.ItshouldbeconsideredasasupplementtoISO14630,whichspecifiesgeneralrequirementsfortheperformanceofnon-activesurgicalimplants.1.2ThispartofISO25539isapplicabletoendovascularprosthesesusedtotreatarterialaneurysms,arterialstenoses,orotherappropriatevascularabnormalities.1.3ThispartofISO25539isapplicabletodeliverysystemsiftheycompriseanintegralcomponentofthedeploymentoftheendovascularprostheses.1.4ThispartofISO25539isnotapplicabletovascularoccluders,withtheexceptionofcontra-lateraliliacoccluderswhenusedasanintegralpartofanaorto-uni-iliacdevice.SeeISO14630forexcludedproducts.1.5ThispartofISO25539isnotapplicabletoproceduresanddevicesusedpriortotheintroductionoftheendovascularsystem(definedin3.6),suchasballoonangioplastydevices.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:98P.;A4
【正文语种】:英语