11.1 PTCA球囊扩张导管技术要求英文翻译

11.1PTCA球囊扩张导管技术要求英文翻译11.1PTCA球囊扩张导管技术要求英文翻译11.1PTCA球囊扩张导管技术要求英文翻译xxx公司11.1PTCA球囊扩张导管技术要求英文翻译文件编号：文件日期：修订次数：第1.0次更改批准审核制定方案设计，管理制度Technicalrequirementsformedicaldeviceproductregistrationnumber：DisposableSterilePTCAballooncatheter1、Model/Specificationsanddivideinstructions1、1ModelPTCA-XX-XXBalloonWorkingLengthmmBalloonnominalDiametermmProductNameCodeModelmarkexample：PTCA——10representsballoonnominalouterdiameterisandworkinglengthis10mmofdisposableSterilePTCAballooncatheter1、2SpecificationsPTCAballooncatheterspecificationlistSpecificationsODLengthTheeffectivelengthofthecatheterMaxguidewirediameterNominalpressureRBP10mm142cm≦8ATM16ATM20mm142cm≦8ATM16ATM30mm142cm≦8ATM16ATM10mm142cm≦8ATM16ATM20mm142cm≦8ATM16ATM30mm142cm≦8ATM16ATM10mm142cm≦8ATM16ATM20mm142cm≦8ATM16ATM30mm142cm≦8ATM16ATM10mm142cm≦8ATM16ATM20mm142cm≦8ATM16ATM30mm142cm≦8ATM16ATM10mm142cm≦8ATM16ATM20mm142cm≦8ATM16ATM30mm142cm≦8ATM16ATM10mm142cm≦8ATM16ATM20mm142cm≦8ATM16ATM30mm142cm≦8ATM16ATM10mm142cm≦6ATM16ATM20mm142cm≦6ATM16ATM30mm142cm≦6ATM16ATM10mm142cm≦6ATM16ATM20mm142cm≦6ATM16ATM30mm142cm≦6ATM16ATM1、3DivideinstructionsDisposableSterilePTCAballooncatheterconsistsofballoon,connectingcatheter,tip,supportcatheterandHandle.Accordingtodifferentballoondiametertodividetheballoonintodifferentspecificationsandsizes.Accordingtomedicaldeviceclassificationrules6877,theballooncatheterbelongingtoClassⅢinterventionalequipmentintravascularcatheter.2、Performance2、1AppearanceAswithnormalvisionorcorrectedvisionatamagnificationoftimestheconditionsofinspection,theeffectivelengthoftheoutercathetershouldbecleanandfreeofimpurities.Thereshouldbenoprocessingdefectsandsurfacedefectsonthesurfaceofcathetereffectivelengthandend.Theinnerandoutersurfaceofthedistalendcomponentsofthecathetershouldhavesiliconeoil(polydimethylsiloxane)lubricantcoating.Withnormalvisionorcorrectedvisioninspection,theoutersurfaceofthecathetershouldnotseetheconvergenceoflubricantdroplets.Note：Theinnerandoutersurfaceofthedistalendcomponentsofthecatheteristheoutsurfacefromthetip(figure1)tothetransitionweld(figure7),andtheinnersurfacefromguidewirelumen(fromthetip(Figure1below)toquicklyswitchports(figure5)).2、2SizerequirementsBallooncathetersizerequirementsreferencetable1,specificationlistreferencetable2.1、Tip2、Balloon3、Radiopaquering4、Outcatheter5、Quicklyswitchports6、Guidewire7、Transitionweld8、HypoTube（FEPCoated）9、Bendingresistanttube10、Handle11Ballooneffectivelength（ L）12、cathetereffectivelengthPic1.PTCAballooncatheterschematicPic2.TipschematicTable1disposableSterilePTCAballooncathetersizeandtolerancerequirementsNameUnitStandardToleranceRemarkBalloondiameterundernominalpressuremmD±BallooneffectivelengthmmL±10%Assemblyintegratedtolerances±10%，Referencepic1.RadiopacityLength（Platinumringspacing）mm(L-1)mm（Lisballooneffectivelength）±10%AdaptedtothemaximumdiameteroftheguidewireInchNANAGuidewirepassthroughguidewirelumensmoothly（Wearintothetip，piercingoutfromfastswitchingport5）MaxcatheterODincomponentsmm±ProximalweldingpointCathetereffectivelengthcm142±2Referencepic1.Tipsizemm2±Referencepic2.outsideofcraterTaperedconnectorConnectorofballooncathetermustbetaperedconnector.SizeshouldbeconsistentwithGB/Trequirements.PhysicalpropertiesBreakingforceBreakingstrengthofeachtestsectionshallcomplywiththerequirementsofTable3.Table3CathetertestsectionbreakingforceMinODofcathetertestsection/mmMinimumbreakingforce/N<≥~<≥~<≥~<≥351015Note:didnotmakeprovisionsforthebreakingforcewhichcatheterODislessthan.Leakagea)Thereshouldnoliquidleakageatcatheterhub,connectionassemblypartandotherpartsofcatheter.Thereshouldbenoleakorsignsofdamageforcatheterorballoon.Ifprominentorburst,thisrequirementadaptbeforehydratedandafterhydrated.b)Inthecontinuousprocessofthesuction，airshouldnotenterintotheassemblypartofcatheter.Thisrequirementadaptbeforehydratedandafterhydrated.RaydetectabilityRadiopaqueringshouldbevisibleunderprovenimagingtechnologywhichintheclinicaluse.TipconfigurationInordertoreducedamagetobloodvesselsduringtheuseprocess，theendoftipshouldbesmoothandhaveataperorthereisacertainprocessorviasimilarfinishing.Particulatepollution

Ballooncatheterproductionshouldundertheminparticulatepollutionconditions,innerandoutsurfaceofcathetershouldbecleanandpollutionindexshallcomplywiththerequirementsofGB8368-2005inChapter.Non-hydratableChangesofeffectivebeforeandafterhydrationshouldnotexceed4mmor1%higherthanbeforehydration（Takemin）；andmaxODchangesbeforeandafterhydrationshouldnotexceed10%ofmaxOD.ChemicalpropertiesCorrosionresistanceShallcomplywiththerequirementsofYY.Reducingsubstance（Readilyoxidizablesubstance）Thevolumedifferencebetweentestliquidandblankliquidconsumepotassiumpermanganatesolution[c(KmnO4)=/l]shallnotexceed.

cThetotalcontentofbarium,chromium,copper,lead,tininthetestliquidshouldnotexceed1μg/ml,Cadmiumcontentshouldnotexceedμg/ml.

PHThedifferencebetweentestpHvalueandthecontrolofpHvalueshouldbelessthan.

ResidualethyleneoxideResidualethyleneoxideofballooncathetershouldnotmorethan10ug/g.Ballooncathetershouldbesterile.Ballooncatheterendotoxincontentshouldnotexceedeach.3.TestMethodAppearanceWithnormalorcorrectedvisionattimesmagnificationinspection,Itshouldmeettherequirementsof.SizeandcolorWithgeneralgaugefortesting,colorwithvisual.Itshouldmeettherequirementsof.PhysicalpropertiesBreakingforceThemethodaccordingtoYY/giveninAppendixB,anditshallcomplywiththerequirementsofLeakagea)ThemethodaccordingtoYYgiveninAppendixC,anditshallcomplywiththerequirementsofa.b)ThemethodaccordingtoYYgiveninAppendixD,anditshallcomplywiththerequirementsofb.RaydetectabilityUsinghospitalconventionalmethodtoperformfilm.TipconfigurationWithnormalorcorrectedvisionattimesmagnificationinspection.ParticulatepollutionThemethodaccordingtoGB8368-2005giveninAppendixchapter,theresultsshouldmeettherequirementsofNon-hydratableAccordingtoYYspecifiedin，immerseballooncatheterinto（37℃±1℃）twohoursandthenmeasurethesize,itshallcomplywiththerequirementsofChemicalpropertiesPreparationoftestsolutionaccordingtoGB/Chapter,paragraph6atableintheprovisions。CorrosionresistanceCarriedoutaccordingtothemethodgiveninAppendixAofYY,itshouldmeettherequirementsof。Reducingsubstance（Readilyoxidizablesubstance）TestinaccordancewithGB/provisionsofChapter,itshallcomplywiththerequirementsof。

MetalionTestinaccordancewithGB/provisionsofChaptershallcomplywiththerequirementsof

PHTestinaccordancewithGB/provisionsofChaptershallcomplywiththerequirementsof

ResidualethyleneoxideTestinaccordancewithGB/provisionsofChapter9,itshallcomplywiththerequirementsofSterileTestinaccordancewithGB/provisionsofChapter3,itshallcomplywiththerequirementsofBacterialendotoxinExperimentsconductedinaccordancewithPartIVrecommendedtestmethods,itshallcomplywiththerequirementsof、TermDuringtheusingprocessofdisposableSterilePTCAballooncatheter,First,transporttheguidewiretothelesionlocation,thenpenetratetheendofguidewirefromthetipandpierceoutfromguidewirelumen.ThenundertheX-rayimagetoobservetheradiopaqueringwhichalongtheguidewiredeliverythecathetertothelesion.Thecathetertipconnecttothepressurepumpandgivethepressuretothecatheter.Therebyfillingtheballoonunderthefoldedstate,Propupthelesion,afterrepeatedevacuationfilling,observethattheeffectissuitable,thenwithdrawalthecatheterandguidewire.Toachievethepurposeofclearthebloodvessels.DisposableSterilePTCAballooncatheterconsistsofstainlesssteelsupportrods,balloon,Balloonconnectingcatheter,balloontip,guidewirelumen,taperconnector.DisposablesterilePTCAballooncathetermadeofmedicalpolymermaterials,themainrawmaterialforismedicalnylon,PCparticlespelletsandstainlesssteel.Rawmaterialsforitsproductshavebeenwidelyused.Suchassingle-usemedicalequipment,itssafetyhasbeendemonstrated.Accordingtotheprovisionsof"People'sRepublicofChinaStandardizationLaw","People'sRepublicofChinaProductQualityLaw","SupervisionandRegulationofMedicalDevices"and、，inordertostandardizethetechnicalcharacteristicsoftheproduct,toensureproductsafetyandeffective，Formulatedregisteredproductstandardsasitsbasisintheproduction,testingandmarketing.Criteriaareasfollows:GB191-2008PackingandstoragediagramGB/TSyringes,needlesandothermedicalequipment-6%(Luer)taperfittings-Part1:GeneralrequirementsGB/TSamplingproceduresforinspection-Part1:byacceptancequalitylimit(AQL)retrievalbatchinspectionsamplingplanGB/T2829-2002PeriodicinspectionSamplingproceduresandtables(suitableforprocessstabilitytest)GB/T8368-2005DisposableinfusionGravityinfusionformulaGB/TInfusion,transfusion,injectionequipmentpartI:ChemicalanalysismethodsGB/TInfusion,transfusion,injectionequipmenttestingmethodsPartII:BioanalyticalMethodGB/TBiologicalevaluationofmedicaldevices-Part1:EvaluationoftheriskmanagementprocessandTestGB/TBiologicalevaluationofmedicaldevices-Part4:SelectionoftestsforinteractionswithbloodGB/TBiologicalevaluationofmedicaldevices-Part5:vitrocytotoxicitytestsGB/TBiologicalevaluationofmedicaldevices-Part7:EthyleneoxidesterilizationresidualsGB/TBiologicalevaluationofmedicaldevices-Part10:stimulationanddelayhypersensitivitytestGB/TBiologicalevaluationofmedicaldevices-Part11:TestsforsystemictoxicityGB/TBiologicalevaluationofmedicaldevices-Part10:SamplepreparationandreferencesampleGB19335-2003TrailusedisposableproductsGeneraltechnicalrequirementsYYSterilesingle-useintravascularcatheters-Part1:GeneralrequirementsYYSterilesingle-useintravascularcatheters-Part4:BallooncathetersYY/T0313-1998Packaging,labeling,transportationandstorageforMedicalPolymerproductsYY/T0663-2008ActivesurgicalimplantsParticularrequirementsforcardiacandvascularimplants