DIN EN ISO 25539-2-2009 心血管植入物.心血管装置.第2部分:血管支架(ISO25539-2-2008).德文版本ENISO25539-2-2009
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【英文标准名称】:Cardiovascularimplants-Endovasculardevices-Part2:Vascularstents(ISO25539-2:2008);GermanversionENISO25539-2:2009
【原文标准名称】:心血管植入物.心血管装置.第2部分:血管支架(ISO25539-2-2008).德文版本ENISO25539-2-2009
【标准号】:DINENISO25539-2-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:心脏病学;定义;植入物(外科);使用说明书;作标记;医疗设备;医学科学;包装件;修复装置;规范(验收);支架;外科学;外科植入物;血管假体;血管支架
【英文主题词】:Cardiology;Definitions;Implants(surgical);Instructionsforuse;Marking;Medicalequipment;Medicalsciences;Packages;Prostheticdevices;Specification(approval);Stents;Surgery;Surgicalimplants;Vascularprostheses;Vascularstents
【摘要】:1.1ThispartofISO25539specifiesrequirementsforvascularstents,baseduponcurrentmedicalknowledge.Withregardtosafety,itgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationsuppliedbythemanufacturer.ItshouldbeconsideredasasupplementtoISO14630,whichspecifiesgeneralrequirementsfortheperformanceofnon-activesurgicalimplants.NOTEDuetothevariationsinthedesignofimplantscoveredbythispartofISO25539andinsomecasesduetotherelativelyrecentdevelopmentofsomeoftheseimplants(e.g.bioabsorbablestents,polymericstents),acceptablestandardizedinvitrotestsandclinicalresultsarenotalwaysavailable.Asfurtherscientificandclinicaldatabecomeavailable,appropriaterevisionofthisdocumentwillbenecessary.1.2ThescopeofthispartofISO25539includesvascularstentsusedtotreatvascularlesionsorstenoses,orothervascularabnormalities.Thesedevicesmightormightnotincorporatesurfacemodificationsofthestentsuchasdrugand/orothercoatings.StentscoveredwithmaterialsthatsignificantlymodifythepermeabilityoftheuncoveredstentarewithinthescopeofISO25539-1.ThestentdesignmightdictatetheneedtoaddressfunctionalrequirementsidentifiedinbothISO25539-1andthispartofISO25539.1.3DeliverysystemsareincludedinthispartofISO25539iftheycompriseanintegralcomponentofthedeploymentofthevascularstent.1.4Proceduresanddevicesusedpriortotheintroductionofthevascularstent,suchasballoonangioplastydevices,areexcludedfromthescopeofthispartofISO25539.1.5SomepharmacologicalaspectsofdrugelutingstentsareaddressedinthispartofISO25539,butthisdocumentisnotcomprehensivewithrespecttothepharmacologicalevaluationofdrugelutingstents.1.6Degradationandothertime-dependentaspectsofbioabsorbableandpolymericstentsandcoatingsarenotaddressedbythispartofISO25539.1.7Withtheexceptionofsterilization,thispartofISO25539doesnotaddressrequirementsfortheevaluationofanimaltissueproducts.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:124P;A4
【正文语种】:德语
【原文标准名称】:心血管植入物.心血管装置.第2部分:血管支架(ISO25539-2-2008).德文版本ENISO25539-2-2009
【标准号】:DINENISO25539-2-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:心脏病学;定义;植入物(外科);使用说明书;作标记;医疗设备;医学科学;包装件;修复装置;规范(验收);支架;外科学;外科植入物;血管假体;血管支架
【英文主题词】:Cardiology;Definitions;Implants(surgical);Instructionsforuse;Marking;Medicalequipment;Medicalsciences;Packages;Prostheticdevices;Specification(approval);Stents;Surgery;Surgicalimplants;Vascularprostheses;Vascularstents
【摘要】:1.1ThispartofISO25539specifiesrequirementsforvascularstents,baseduponcurrentmedicalknowledge.Withregardtosafety,itgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacturing,sterilization,packagingandinformationsuppliedbythemanufacturer.ItshouldbeconsideredasasupplementtoISO14630,whichspecifiesgeneralrequirementsfortheperformanceofnon-activesurgicalimplants.NOTEDuetothevariationsinthedesignofimplantscoveredbythispartofISO25539andinsomecasesduetotherelativelyrecentdevelopmentofsomeoftheseimplants(e.g.bioabsorbablestents,polymericstents),acceptablestandardizedinvitrotestsandclinicalresultsarenotalwaysavailable.Asfurtherscientificandclinicaldatabecomeavailable,appropriaterevisionofthisdocumentwillbenecessary.1.2ThescopeofthispartofISO25539includesvascularstentsusedtotreatvascularlesionsorstenoses,orothervascularabnormalities.Thesedevicesmightormightnotincorporatesurfacemodificationsofthestentsuchasdrugand/orothercoatings.StentscoveredwithmaterialsthatsignificantlymodifythepermeabilityoftheuncoveredstentarewithinthescopeofISO25539-1.ThestentdesignmightdictatetheneedtoaddressfunctionalrequirementsidentifiedinbothISO25539-1andthispartofISO25539.1.3DeliverysystemsareincludedinthispartofISO25539iftheycompriseanintegralcomponentofthedeploymentofthevascularstent.1.4Proceduresanddevicesusedpriortotheintroductionofthevascularstent,suchasballoonangioplastydevices,areexcludedfromthescopeofthispartofISO25539.1.5SomepharmacologicalaspectsofdrugelutingstentsareaddressedinthispartofISO25539,butthisdocumentisnotcomprehensivewithrespecttothepharmacologicalevaluationofdrugelutingstents.1.6Degradationandothertime-dependentaspectsofbioabsorbableandpolymericstentsandcoatingsarenotaddressedbythispartofISO25539.1.7Withtheexceptionofsterilization,thispartofISO25539doesnotaddressrequirementsfortheevaluationofanimaltissueproducts.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:124P;A4
【正文语种】:德语
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