ISO 25539-1-2003 心血管植入物.血管内器械.第1部分:血管内假体
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【英文标准名称】:Cardiovascularimplants-Endovasculardevices-Part1:Endovascularprostheses
【原文标准名称】:心血管植入物.血管内器械.第1部分:血管内假体
【标准号】:ISO25539-1-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:验收规范;心脏病学;定义;设计;血管的;使用说明书;作标记;材料;医疗设备;包装件;性能;修复装置;规范(验收);无菌的;灭菌;外科植入物;测试;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】:1ThispartofISO25539specifiesrequirementsforendovascularprostheses,baseduponcurrentmedicalknowledge.Withregardtosafety,itgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilizationpackagingandinformationsuppliedbythemanufacturer.ItshouldbeconsideredasasupplementtoISO14630,whichspecifiesgeneralrequirementsfortheperformanceofnon-activesurgicalimplants.2ThispartofISO25539isapplicabletoendovascularprosthesesusedtotreatarterialaneurysms,arterialstenoses,orotherappropriatevascularabnormalities.3ThispartofISO25539isapplicabletodeliverysystemsiftheycompriseanintegralcomponentofthedeploymentoftheendovascularprostheses.4ThispartofISO25539isnotapplicabletovascularoccluders,withtheexceptionofcontra-lateraliliacoccluderswhenusedasanintegralpartofanaorto-uni-iliacdevice.SeeISO14630forexcludedproducts.5ThispartofISO25539isnotapplicabletoproceduresanddevicesusedpriortotheintroductionoftheendovascularsystem(definedin3.6),suchasballoonangioplastydevices.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:42P;A4
【正文语种】:英语
【原文标准名称】:心血管植入物.血管内器械.第1部分:血管内假体
【标准号】:ISO25539-1-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:验收规范;心脏病学;定义;设计;血管的;使用说明书;作标记;材料;医疗设备;包装件;性能;修复装置;规范(验收);无菌的;灭菌;外科植入物;测试;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】:1ThispartofISO25539specifiesrequirementsforendovascularprostheses,baseduponcurrentmedicalknowledge.Withregardtosafety,itgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilizationpackagingandinformationsuppliedbythemanufacturer.ItshouldbeconsideredasasupplementtoISO14630,whichspecifiesgeneralrequirementsfortheperformanceofnon-activesurgicalimplants.2ThispartofISO25539isapplicabletoendovascularprosthesesusedtotreatarterialaneurysms,arterialstenoses,orotherappropriatevascularabnormalities.3ThispartofISO25539isapplicabletodeliverysystemsiftheycompriseanintegralcomponentofthedeploymentoftheendovascularprostheses.4ThispartofISO25539isnotapplicabletovascularoccluders,withtheexceptionofcontra-lateraliliacoccluderswhenusedasanintegralpartofanaorto-uni-iliacdevice.SeeISO14630forexcludedproducts.5ThispartofISO25539isnotapplicabletoproceduresanddevicesusedpriortotheintroductionoftheendovascularsystem(definedin3.6),suchasballoonangioplastydevices.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:42P;A4
【正文语种】:英语
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