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【英文标准名称】:StandardGuideforCharacterizationandPresentationoftheDimensionalAttributesofVascularStents
【原文标准名称】:维管展幅尺寸属性的特征描述和表示的标准指南
【标准号】:ASTMF2081-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.30
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:尺寸;医学装置;表示;外科植入物;手术器械;维管展幅
【英文主题词】:angioplasty;coronaryartery;dimensionalcharacteristics;dimensions;vascularstent
【摘要】:Vascularstentsareintendedforpermanentimplantinthehumanvasculature(nativeorgraft)forthepurposesofmaintainingvesselpatency.Thedimensionalattributesofvascularstentsarecriticalparametersthataidcliniciansintheselectionofdevicesforindividualpatients.Thisguidecontainsalistingofthosedimensionalattributesthataredirectlyrelatedtotheclinicalutilityandperformanceofthesedevices,alongwithrecommendationsforconsistentmethodsofmeasuringtheseattributesandpresentingtheinformationforuseinclinicaldecisionmaking.Thisguidecanbeusedbythemanufacturersandresearchersofstentstoprovideconsistencyofmeasurementandlabelingofthesedimensionalcharacteristics.Itmayhaveuseintheregulationofthesedevicesbyappropriateauthorities.Thedimensionalattributesincludedinthisguidearethosethataredeemedrelatedtoorpossiblypredictiveofsuccessfulclinicalperformanceofthestent,basedonpriorclinicalexperience;however,becauseofthemyriadpatientandmedicalfactorsthatinfluencetheclinicaloutcomeofanyindividualtreatment,conformanceofastentanddeliverysystemwiththerecommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanyindividualpatientorgroupofpatients.1.1Thisguidecoverstheidentificationofandrecommendedmeasurementmethodsforthosedimensionalattributesofvascularstentsthataredeemedrelevanttosuccessfulclinicalperformance.Thedeliverysystempackagedwithandlabeledspecificallyforuseduringtheplacementofthestentisalsoincludedwithinthescopeofthisguide.1.2Thisguideaddressesonlythedimensionalcharacteristicsofstents.Materialpropertyandstentfunctionalcharacteristicsarenotaddressedherein.Alldimensionalcharacteristicsdescribedinthisguiderefertoinvitro("bench-top")characterization.Becauseofvariablepatientfactors,forexample,vesselcompliance,theactualinvivocharacteristicsmaybeslightlydifferent.1.3Thisguideincludesrecommendationsgenerallyapplicabletoballoon-expandableandself-expandingstentsfabricatedfrommetalsandmetalalloys.Itdoesnotspecificallyaddressanyattributesuniquetocoatedstentsorpolymericorbiodegradablestents,althoughtheapplicationofthisguidetothoseproductsisnotprecluded.1.4Whiletheyarenotspecificallyincludedwithinthescopeofthisguide,stentsindicatedforplacementinnonvascularlocations,suchastheesophagusorbileduct,alsomightbecharacterizedbythemethodscontainedherein.Likewise,thisguidedoesnotincluderecommendationsforendovasculargrafts("stent-grafts")orotherconduitdevicescommonlyusedtotreataneurysmaldiseaseorperipheralvesseltraumaortoprovidevascularaccess,althoughsomeinformationincludedhereinmaybeapplicabletothosedevices.1.5Thisguidedoesnotincluderecommendationsforballooncatheterssoldasstand-aloneangioplastycatheters,eventhoughsomeofthosecathetersmaybeusedforthedeliveryofunmountedstentssuppliedwithoutadeliverysystem.RequirementsforangioplastycathetersarecontainedinstandardsISO10555-1andISO10555-4.1.6TheunitsofmeasurementsusedthroughoutthisguidereflectthehybridsystemincommonclinicaluseintheUnitedStatesasofthetimeoftheoriginalapprovalofthisguide.Sinceaprimarypurposeofthisguideistopromoteuniformityoflabelingtofacilitatetheselectionofdevicesbyclinicalusers,theunitsmostpreferredbyuserswereselectedforthisguide.WherethoseunitsarenotSIunits,orderivativesthereof,SIunitsareprovidedinparentheses.
【中国标准分类号】:C31
【国际标准分类号】:11_040_20
【页数】:5P.;A4
【正文语种】: