ISO 21534-2007_第1页
ISO 21534-2007_第2页
ISO 21534-2007_第3页
ISO 21534-2007_第4页
ISO 21534-2007_第5页
已阅读5页，还剩15页未读， 继续免费阅读

下载本文档

版权说明：本文档由用户提供并上传，收益归属内容提供方，若内容存在侵权，请进行举报或认领

文档简介

REFERENCENUMBERISO215342007EISO2007INTERNATIONALSTANDARDISO21534SECONDEDITION20071001NONACTIVESURGICALIMPLANTSJOINTREPLACEMENTIMPLANTSPARTICULARREQUIREMENTSIMPLANTSCHIRURGICAUXNONACTIFSIMPLANTSDEREMPLACEMENTDARTICULATIONEXIGENCESPARTICULIRESCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EPDFDISCLAIMERTHISPDFFILEMAYCONTAINEMBEDDEDTYPEFACESINACCORDANCEWITHADOBESLICENSINGPOLICY,THISFILEMAYBEPRINTEDORVIEWEDBUTSHALLNOTBEEDITEDUNLESSTHETYPEFACESWHICHAREEMBEDDEDARELICENSEDTOANDINSTALLEDONTHECOMPUTERPERFORMINGTHEEDITINGINDOWNLOADINGTHISFILE,PARTIESACCEPTTHEREINTHERESPONSIBILITYOFNOTINFRINGINGADOBESLICENSINGPOLICYTHEISOCENTRALSECRETARIATACCEPTSNOLIABILITYINTHISAREAADOBEISATRADEMARKOFADOBESYSTEMSINCORPORATEDDETAILSOFTHESOFTWAREPRODUCTSUSEDTOCREATETHISPDFFILECANBEFOUNDINTHEGENERALINFORELATIVETOTHEFILETHEPDFCREATIONPARAMETERSWEREOPTIMIZEDFORPRINTINGEVERYCAREHASBEENTAKENTOENSURETHATTHEFILEISSUITABLEFORUSEBYISOMEMBERBODIESINTHEUNLIKELYEVENTTHATAPROBLEMRELATINGTOITISFOUND,PLEASEINFORMTHECENTRALSECRETARIATATTHEADDRESSGIVENBELOWCOPYRIGHTPROTECTEDDOCUMENTISO2007ALLRIGHTSRESERVEDUNLESSOTHERWISESPECIFIED,NOPARTOFTHISPUBLICATIONMAYBEREPRODUCEDORUTILIZEDINANYFORMORBYANYMEANS,ELECTRONICORMECHANICAL,INCLUDINGPHOTOCOPYINGANDMICROFILM,WITHOUTPERMISSIONINWRITINGFROMEITHERISOATTHEADDRESSBELOWORISOSMEMBERBODYINTHECOUNTRYOFTHEREQUESTERISOCOPYRIGHTOFFICECASEPOSTALE56CH1211GENEVA20TEL41227490111FAX41227490947EMAILCOPYRIGHTISOORGWEBWWWISOORGPUBLISHEDINSWITZERLANDIIISO2007ALLRIGHTSRESERVEDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EISO2007ALLRIGHTSRESERVEDIIICONTENTSPAGEFOREWORDVINTRODUCTIONVI1SCOPE12NORMATIVEREFERENCES13TERMSANDDEFINITIONS24INTENDEDPERFORMANCE25DESIGNATTRIBUTES351GENERAL352SURFACEFINISHOFMETALLICORCERAMICIMPLANTSARTICULATINGONULTRAHIGHMOLECULARWEIGHTPOLYETHYLENEUHMWPE353SURFACEFINISHOFMETALLICORCERAMICPARTIALIMPLANTS354SURFACESOFCONVEX,SPHERICALLYCONFORMINGMETALLICORCERAMICIMPLANTSARTICULATINGONUHMWPE355SURFACESOFSPHERICALLYCONFORMINGMETALLICORCERAMICPARTIALIMPLANTS356SURFACESOFCONCAVE,SPHERICALLYCONFORMINGUHMWPECOMPONENTS36MATERIALS461GENERAL462DISSIMILARMETALSORALLOYS47DESIGNEVALUATION471GENERAL472PRECLINICALEVALUATION473CLINICALINVESTIGATION574POSTMARKETSURVEILLANCE58MANUFACTUREANDINSPECTION581GENERAL582METALSURFACES583PLASTICSURFACES584CERAMICSURFACES59STERILIZATION691GENERAL692EXPIRY610PACKAGING611INFORMATIONSUPPLIEDBYTHEMANUFACTURER6111GENERAL6112LABELLINGOFIMPLANTSFORUSEONONESIDEOFTHEBODYONLY6113INSTRUCTIONSFORORIENTATIONOFIMPLANTS6114MARKINGSFORORIENTATIONOFTHEIMPLANTS6115PLACINGOFMARKINGSONIMPLANTS6116RESTRICTIONSONUSE7117RESTERILIZATIONOFZIRCONIACERAMICS7118LABELLINGOFIMPLANTSFORUSEWITHORWITHOUTBONECEMENT7ANNEXAINFORMATIVELISTOFINTERNATIONALSTANDARDSFORMATERIALSFOUNDACCEPTABLEFORTHEMANUFACTUREOFIMPLANTS8ANNEXBINFORMATIVELISTOFINTERNATIONALSTANDARDSFORMATERIALSFOUNDACCEPTABLEORNOTACCEPTABLEFORARTICULATINGSURFACESOFIMPLANTS9COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EIVISO2007ALLRIGHTSRESERVEDANNEXCINFORMATIVELISTOFMATERIALSFOUNDACCEPTABLEORNONACCEPTABLEFORMETALLICCOMBINATIONSFORNONARTICULATINGCONTACTINGSURFACESOFIMPLANTS11BIBLIOGRAPHY12COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EISO2007ALLRIGHTSRESERVEDVFOREWORDISOTHEINTERNATIONALORGANIZATIONFORSTANDARDIZATIONISAWORLDWIDEFEDERATIONOFNATIONALSTANDARDSBODIESISOMEMBERBODIESTHEWORKOFPREPARINGINTERNATIONALSTANDARDSISNORMALLYCARRIEDOUTTHROUGHISOTECHNICALCOMMITTEESEACHMEMBERBODYINTERESTEDINASUBJECTFORWHICHATECHNICALCOMMITTEEHASBEENESTABLISHEDHASTHERIGHTTOBEREPRESENTEDONTHATCOMMITTEEINTERNATIONALORGANIZATIONS,GOVERNMENTALANDNONGOVERNMENTAL,INLIAISONWITHISO,ALSOTAKEPARTINTHEWORKISOCOLLABORATESCLOSELYWITHTHEINTERNATIONALELECTROTECHNICALCOMMISSIONIECONALLMATTERSOFELECTROTECHNICALSTANDARDIZATIONINTERNATIONALSTANDARDSAREDRAFTEDINACCORDANCEWITHTHERULESGIVENINTHEISO/IECDIRECTIVES,PART2THEMAINTASKOFTECHNICALCOMMITTEESISTOPREPAREINTERNATIONALSTANDARDSDRAFTINTERNATIONALSTANDARDSADOPTEDBYTHETECHNICALCOMMITTEESARECIRCULATEDTOTHEMEMBERBODIESFORVOTINGPUBLICATIONASANINTERNATIONALSTANDARDREQUIRESAPPROVALBYATLEAST75OFTHEMEMBERBODIESCASTINGAVOTEATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSISOSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSISO21534WASPREPAREDBYTECHNICALCOMMITTEEISO/TC150,IMPLANTSFORSURGERY,SUBCOMMITTEESC4,BONEANDJOINTREPLACEMENTSTHISSECONDEDITIONCANCELSANDREPLACESTHEFIRSTEDITIONISO215342002,WHICHHASBEENTECHNICALLYREVISEDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EVIISO2007ALLRIGHTSRESERVEDINTRODUCTIONTHEREARETHREELEVELSOFINTERNATIONALSTANDARDDEALINGWITHNONACTIVESURGICALIMPLANTSTHESEAREASFOLLOWS,WITHLEVEL1BEINGTHEHIGHESTLEVEL1GENERALREQUIREMENTSFORNONACTIVESURGICALIMPLANTSANDINSTRUMENTATIONUSEDINASSOCIATIONWITHIMPLANTSLEVEL2PARTICULARREQUIREMENTSFORFAMILIESOFNONACTIVESURGICALIMPLANTSLEVEL3SPECIFICREQUIREMENTSFORTYPESOFNONACTIVESURGICALIMPLANTTHISINTERNATIONALSTANDARDISALEVEL2STANDARDANDCONTAINSREQUIREMENTSTHATAPPLYTOALLNONACTIVESURGICALIMPLANTSINTHEFAMILYOFJOINTREPLACEMENTIMPLANTSTHELEVEL1STANDARDCONTAINSREQUIREMENTSTHATAPPLYTOALLNONACTIVESURGICALIMPLANTSITALSOINDICATESTHATTHEREAREADDITIONALREQUIREMENTSINTHELEVEL2ANDLEVEL3STANDARDSTHELEVEL1STANDARDHASBEENPUBLISHEDASISO14630LEVEL3STANDARDSAPPLYTOSPECIFICTYPESOFIMPLANTSWITHINAFAMILY,SUCHASKNEEANDHIPJOINTSTOADDRESSALLREQUIREMENTS,ITISRECOMMENDEDTHATASTANDARDOFTHELOWESTAVAILABLELEVELBECONSULTEDFIRSTCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,INTERNATIONALSTANDARDISO215342007EISO2007ALLRIGHTSRESERVED1NONACTIVESURGICALIMPLANTSJOINTREPLACEMENTIMPLANTSPARTICULARREQUIREMENTS1SCOPETHISINTERNATIONALSTANDARDSPECIFIESPARTICULARREQUIREMENTSFORTOTALANDPARTIALJOINTREPLACEMENTIMPLANTS,ARTIFICIALLIGAMENTSANDBONECEMENT,HEREAFTERREFERREDTOASIMPLANTSFORTHEPURPOSESOFTHISINTERNATIONALSTANDARD,ARTIFICIALLIGAMENTSANDTHEIRASSOCIATEDFIXINGDEVICESAREINCLUDEDINTHETERM“IMPLANT“ITSPECIFIESREQUIREMENTSFORINTENDEDPERFORMANCE,DESIGNATTRIBUTES,MATERIALS,DESIGNEVALUATION,MANUFACTURING,STERILIZATION,PACKAGINGANDINFORMATIONTOBESUPPLIEDBYTHEMANUFACTURERSOMETESTSREQUIREDTODEMONSTRATECONFORMANCETOTHISINTERNATIONALSTANDARDARECONTAINEDINORREFERENCEDINLEVEL3STANDARDS2NORMATIVEREFERENCESTHEFOLLOWINGREFERENCEDDOCUMENTSAREINDISPENSABLEFORTHEAPPLICATIONOFTHISDOCUMENTFORDATEDREFERENCES,ONLYTHEEDITIONCITEDAPPLIESFORUNDATEDREFERENCES,THELATESTEDITIONOFTHEREFERENCEDDOCUMENTINCLUDINGANYAMENDMENTSAPPLIESISO4287,GEOMETRICALPRODUCTSPECIFICATIONSGPSSURFACETEXTUREPROFILEMETHODTERMS,DEFINITIONSANDSURFACETEXTUREPARAMETERSISO72064,IMPLANTSFORSURGERYPARTIALANDTOTALHIPJOINTPROSTHESESPART4DETERMINATIONOFENDURANCEPROPERTIESOFSTEMMEDFEMORALCOMPONENTSISO72068,IMPLANTSFORSURGERYPARTIALANDTOTALHIPJOINTPROSTHESESPART8METHODSOFDETERMININGENDURANCEPERFORMANCEOFSTEMMEDFEMORALCOMPONENTSISO141551,CLINICALINVESTIGATIONOFMEDICALDEVICESFORHUMANSUBJECTSPART1GENERALREQUIREMENTSISO142421,IMPLANTSFORSURGERYWEAROFTOTALHIPJOINTPROSTHESESPART1LOADINGANDDISPLACEMENTPARAMETERSFORWEARTESTINGMACHINESANDCORRESPONDINGENVIRONMENTALCONDITIONSFORTESTSISO142422,IMPLANTSFORSURGERYWEAROFTOTALHIPJOINTPROSTHESESPART2METHODSOFMEASUREMENTISO142432,IMPLANTSFORSURGERYWEAROFTOTALKNEEJOINTPROSTHESESPART2METHODSOFMEASUREMENTISO146301,NONACTIVESURGICALIMPLANTSGENERALREQUIREMENTSISO148791,IMPLANTSFORSURGERYTOTALKNEEJOINTPROSTHESESPART1DETERMINATIONOFENDURANCEPROPERTIESOFKNEETIBIALTRAYS1TOBEPUBLISHEDREVISIONOFISO146302005COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007E2ISO2007ALLRIGHTSRESERVED3TERMSANDDEFINITIONSFORTHEPURPOSESOFTHISDOCUMENT,THETERMSANDDEFINITIONSINISO14630TOGETHERWITHTHEFOLLOWINGAPPLY31ARTIFICIALLIGAMENTDEVICE,INCLUDINGITSNECESSARYFIXINGDEVICES,INTENDEDTOAUGMENTORREPLACETHENATURALLIGAMENT32JOINTREPLACEMENTIMPLANTIMPLANTABLEDEVICE,INCLUDINGANCILLARYIMPLANTEDCOMPONENTSANDMATERIALS,INTENDEDTOPROVIDEFUNCTIONSIMILARTOANATURALJOINTANDWHICHISCONNECTEDTOTHECORRESPONDINGBONES33MEANCENTREPOSITIONWITHINTHESPHERICALHEADFORWHICHTHEAVERAGEOFTHEDISTANCESTOASETOFPOINTSUNIFORMLYDISTRIBUTEDOVERTHESURFACEOFTHESPHEREISMINIMUM34RADIALSEPARATIONVALUEDIFFERENCEBETWEENTHEMEANRADIUSOFTHESPHERICALSURFACEANDTHERADIUSTOTHEPOINTONTHESPHERICALSURFACEFURTHESTFROMTHEMEANCENTRENOTETHEUNITSOFTHERADIALSEPARATIONVALUEAREINMICROMETRES4INTENDEDPERFORMANCEFORTHEPURPOSEOFTHISINTERNATIONALSTANDARD,THEINTENDEDPERFORMANCEOFIMPLANTSSHALLCONFORMTOCLAUSE4OFISO14630,ANDTHEDESIGNINPUTSHALLADDITIONALLYADDRESSTHEFOLLOWINGMATTERSAINTENDEDMINIMUMANDMAXIMUMRELATIVEANGULARMOVEMENTBETWEENTHESKELETALPARTSTOWHICHTHEJOINTREPLACEMENTIMPLANTISATTACHEDBEXPECTEDMAXIMUMLOADACTIONSFORCESANDMOMENTSTOBETRANSMITTEDTOTHEBONYPARTSTOWHICHTHEJOINTREPLACEMENTIMPLANTISATTACHEDCDYNAMICRESPONSEOFTHEBODYTOTHESHAPE/STIFFNESSOFTHEIMPLANTSDEXPECTEDWEAROFARTICULATINGSURFACESESUITABILITYOFTHEDIMENSIONSANDSHAPEOFTHEIMPLANTFORTHEPOPULATIONFORWHICHITISINTENDEDFSTRENGTHOFTHEADHESIONANDDURABILITYOFSURFACECOATINGSORSURFACETREATMENTSNOTE1THECLINICALINDICATIONSANDCONTRAINDICATIONSFORTHEUSEOFAPARTICULARIMPLANTARECOMPLEXANDSHOULDBEREVIEWEDBYTHESURGEONSWHENTHEYARESELECTINGIMPLANTSTOBEUSEDFORPARTICULARPATIENTS,RELYINGUPONTHEIROWNPERSONALJUDGMENTANDEXPERIENCENOTE2THELIFETIMEOFANIMPLANTDEPENDSONTHEINTERACTIONOFVARIOUSFACTORSSOMEARETHERESPONSIBILITYOFTHEMANUFACTURER,SOME,SUCHASTHEIMPLANTATIONTECHNIQUE,ARETHERESPONSIBILITYOFTHESURGEONINCONDUCTINGTHEOPERATION,ANDSOMERELATETOTHEPATIENT,FOREXAMPLE,THEBIOLOGICALANDPHYSIOLOGICALRESPONSETOTHEIMPLANT,THEMEDICALCONDITIONOFTHEPATIENT,THECONDUCTOFTHEPATIENTINRESPECTOFINCREASINGBODYWEIGHT,CARRIAGEOFHEAVYLOADSANDADOPTINGAHIGHLEVELOFPHYSICALACTIVITYCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EISO2007ALLRIGHTSRESERVED35DESIGNATTRIBUTES51GENERALTHEDEVELOPMENTOFTHEDESIGNATTRIBUTESTOMEETTHEPERFORMANCEINTENDEDBYTHEMANUFACTURERSHALLCONFORMTOTHEREQUIREMENTSOFCLAUSE5OFISO14630,ANDINADDITION,ACCOUNTSHALLBETAKENOFTHEFOLLOWINGPOINTSATHESTRENGTHOFADHESIONANDDURABILITYOFSURFACECOATINGSANDSURFACETREATMENTSBTHEWEAROFTHEARTICULATINGANDOTHERSURFACESCSTABILITYOFTHEIMPLANTWHILEALLOWINGPRESCRIBEDMINIMUMANDMAXIMUMRELATIVEMOVEMENTSBETWEENTHESKELETALPARTSDAVOIDANCEOFCUTTINGORABRADINGTISSUEDURINGFUNCTIONOTHERTHANINSERTIONORREMOVALETHECREEPRESISTANCEANDRUPTURECHARACTERISTICS,PARTICULARLYASTHEYRELATETOLIGAMENTSNOTE1METHODSOFASSESSMENTOFTHEWEAROFARTICULATINGANDOTHERSURFACESAREPRESCRIBEDIN,EGISO142422ANDISO142431,2AND3NOTE2MORESPECIFICREQUIREMENTS,SUCHASTHATFORHIPJOINTREPLACEMENTS,MIGHTAPPEARINOTHERSTANDARDS52SURFACEFINISHOFMETALLICORCERAMICIMPLANTSARTICULATINGONULTRAHIGHMOLECULARWEIGHTPOLYETHYLENEUHMWPETHEARTICULATINGSURFACESOFMETALLICORCERAMICCOMPONENTSOFTOTALJOINTREPLACEMENTSINTENDEDTOARTICULATEONUHMWPESHALLHAVEASURFACEROUGHNESSVALUERANOGREATERTHAN0,1MWHENMEASUREDINACCORDANCEWITH72253SURFACEFINISHOFMETALLICORCERAMICPARTIALIMPLANTSTHEARTICULATINGSURFACEOFMETALLICORCERAMICCOMPONENTSOFPARTIALJOINTREPLACEMENTSSHALLHAVEASURFACEROUGHNESSVALUERANOGREATERTHAN0,5MWHENMEASUREDINACCORDANCEWITH72254SURFACESOFCONVEX,SPHERICALLYCONFORMINGMETALLICORCERAMICIMPLANTSARTICULATINGONUHMWPETHEARTICULATINGSURFACEOFCONVEXSPHERICALLYCONFORMINGMETALLICORCERAMICCOMPONENTSOFTOTALJOINTREPLACEMENTSINTENDEDTOARTICULATEONUHMWPESHALLHAVEASURFACEROUGHNESSRANOGREATERTHAN0,05MANDARADIALSEPARATIONVALUEFORSPHERICITYNOGREATERTHAN10MWHENMEASUREDINACCORDANCEWITH722AND72355SURFACESOFSPHERICALLYCONFORMINGMETALLICORCERAMICPARTIALIMPLANTSTHEARTICULATINGSURFACEOFSPHERICALLYCONFORMINGMETALLICORCERAMICCOMPONENTSOFPARTIALJOINTREPLACEMENTSSHALLHAVEASURFACEROUGHNESSVALUERANOGREATERTHAN0,5MANDARADIALSEPARATIONVALUEFORSPHERICITYNOGREATERTHAN100MWHENMEASUREDINACCORDANCEWITH722AND72356SURFACESOFCONCAVE,SPHERICALLYCONFORMINGUHMWPECOMPONENTSTHEARTICULATINGSURFACEOFCONCAVE,SPHERICALLYCONFORMINGUHMWPECOMPONENTSOFTOTALJOINTREPLACEMENTSSHALLHAVEASURFACEROUGHNESSRANOGREATERTHAN2MANDARADIALSEPARATIONVALUEFORSPHERICITYNOGREATERTHAN200MWHENMEASUREDINACCORDANCEWITH722AND723COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007E4ISO2007ALLRIGHTSRESERVED6MATERIALS61GENERALTHEREQUIREMENTSOFCLAUSE6OFISO14630APPLYTOGETHERWITHTHEPARTICULARREQUIREMENTOF62OFTHEPRESENTDOCUMENTNOTE1ANNEXAGIVESALISTOFINTERNATIONALSTANDARDSFORMATERIALSFOUNDACCEPTABLETHROUGHPROVENUSEFORTHEMANUFACTUREOFIMPLANTSORFORUSEINASSOCIATIONWITHIMPLANTSNOTE2ANNEXBGIVESLISTSOFINTERNATIONALSTANDARDSFORPAIRSOFMATERIALSFOUNDACCEPTABLEORNOTACCEPTABLETHROUGHPROVENUSEFORARTICULATINGSURFACESOFIMPLANTSNOTE3WHERE61OFISO14630STATESTHATTHEACCEPTABILITYOFMATERIALSMAYBEDEMONSTRATEDBYSELECTIONFROMTHEMATERIALSFOUNDSUITABLEBYPROVENCLINICALUSEINSIMILARAPPLICATIONS,FORTHEPURPOSESOFTHISINTERNATIONALSTANDARD,PROVENUSESHOULDBEDEMONSTRATEDBYRECORDSOFIMPLANTATIONOFATLEAST500OFTHEIMPLANTSANDRECORDEDSATISFACTORYCLINICALUSEOVERAPERIODOFNOTLESSTHANFIVEYEARS62DISSIMILARMETALSORALLOYSFORAPPLICATIONSINWHICHTWODISSIMILARMETALSORALLOYSORTHESAMEMETALSORALLOYSINDIFFERENTMETALLURGICALSTATESAREINCONTACTWHEREARTICULATIONISNOTINTENDED,COMBINATIONSUSEDSHALLNOTPRODUCEUNACCEPTABLEGALVANICEFFECTSNOTEANNEXCGIVESLISTSOFINTERNATIONALSTANDARDSFORACCEPTABLEANDUNACCEPTABLEMETALLICCOMBINATIONSFORUSEINNONARTICULATINGBEARINGSURFACESOFIMPLANTS7DESIGNEVALUATION71GENERALJOINTREPLACEMENTIMPLANTSSHALLBEEVALUATEDINORDERTODEMONSTRATETHATTHEINTENDEDPERFORMANCEISACHIEVEDTHISEVALUATIONSHALLBEINACCORDANCEWITHCLAUSE7OFISO14630TOGETHERWITHTHEPARTICULARREQUIREMENTSOF72TO74THISEVALUATIONSHALLBEUNDERTAKENUSINGCOMPONENTSFULLYREPRESENTATIVEOFTHEFINALCONDITIONREADYFORIMPLANTATION72PRECLINICALEVALUATION721GENERALPRECLINICALEVALUATIONSHALLCONSIDERABIOCOMPATIBILITYOFANYMATERIALSNOTPREVIOUSLYUSEDBMECHANICALLOADSANDTHERELATEDMOVEMENTSTOWHICHTHEIMPLANTSCANBESUBJECTEDWHENFUNCTIONINGASPRESCRIBEDBYISO14630CFATIGUETESTINGOFHIGHLYSTRESSEDPARTSINACCORDANCEWITHISO72064,ISO72068ANDISO148791DWEARTESTINGOFARTICULATINGBEARINGSURFACESINACCORDANCEWITHEGISO142421,ISO142422ANDISO142431ETHESUITABILITYOFTHEDIMENSIONSANDSHAPEOFTHEIMPLANTFORTHEINTENDEDPOPULATIONNOTETHESUITABILITYOFTHEDIMENSIONSANDSHAPEOFTHEIMPLANTFORTHEINTENDEDPOPULATIONCANBEDEMONSTRATEDBYCADAVERIMPLANTATION,THEUSEOFIMAGINGSYSTEMSSUCHASXRAY,CATSCANORMAGNETICRESONANCEIMAGING,ORBYREFERENCETOCORRESPONDINGIMPLANTSOFPROVENCLINICALUSESEENOTE3OF61FADHESIONANDDURABILITYOFCOATINGSIFPRESENTCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007EISO2007ALLRIGHTSRESERVED5722SURFACEROUGHNESSMEASUREMENTSURFACEROUGHNESSSHALLBEMEASUREDACCORDINGTOONEOFTHEMETHODSGIVENINISO4287723SPHERICITYMEASUREMENTRADIALSEPARATIONVALUESFORSPHERICITYSHALLBEMEASUREDACCORDINGTOAMETHODDEMONSTRATEDTOBEACCURATEANDREPEATABLENOTEASUITABLEMETHODISDESCRIBEDINTHENATIONALPHYSICALLABORATORYNPL3073CLINICALINVESTIGATIONTHECLINICALINVESTIGATIONSHALLBECONDUCTEDACCORDINGTOTHEGENERALREQUIREMENTSOFISO14155174POSTMARKETSURVEILLANCETHEPOSTMARKETPERFORMANCEOFJOINTREPLACEMENTIMPLANTSSHALLBEDETERMINEDNOTESUITABLEMETHODOLOGIESINCLUDESURVIVALANALYSISWITHREVISIONASTHEENDPOINTANDCLINICALASSESSMENTWHEREITISAVAILABLE,RELEVANTINFORMATIONFROMJOINTREPLACEMENTREGISTRIESARETAKENINTOACCOUNT8MANUFACTUREANDINSPECTION81GENERALTHEREQUIREMENTSOFCLAUSE8OFISO14630APPLYTOGETHERWITHTHEPARTICULARREQUIREMENTSOF82TO8482METALSURFACESALLPOLISHINGOPERATIONSONMETALLICCOMPONENTSSHALLBEPERFORMEDUSINGANIRONFREEMATERIALCLEAN,DEGREASE,RINSEANDDRYALLCOMPONENTSANDEXAMINETHEARTICULATINGSURFACESUSINGNORMALORCORRECTEDVISIONTHESURFACESSHALLBEFREEOFANYIMPERFECTIONSTHATWOULDIMPAIRTHEIRFUNCTIONANDALSOBEFREEFROMDEPOSITEDFINISHINGMATERIALSOROTHERCONTAMINANTSNOTEEXAMPLESOFIMPERFECTIONSWHICHMIGHTIMPAIRFUNCTIONINCLUDESCALE,TOOLMARKS,NICKS,SCRATCHES,CRACKS,CAVITIES,BURRSANDOTHERDEFECTS83PLASTICSURFACESARTICULATINGSURFACESOFPLASTICCOMPONENTSSHALLNOTBEPREPAREDUSINGNONREMOVABLEABRASIVEORPOLISHINGCOMPOUNDSCLEAN,DEGREASEIFNECESSARY,RINSEANDDRYTHECOMPONENTSANDEXAMINETHEMUSINGNORMALORCORRECTEDVISIONTHESURFACESSHALLBEFREEFROMPARTICULATECONTAMINATION84CERAMICSURFACESCERAMICCOMPONENTSSHALLBECLEANED,DEGREASED,RINSED,DRIEDANDEXAMINEDUSINGNORMALORCORRECTEDVISIONTHEARTICULATINGSURFACESSHALLBEFREEOFANYIMPERFECTIONSTHATWOULDIMPAIRTHEIRFUNCTIONNOTEEXAMPLESOFIMPERFECTIONSWHICHMIGHTIMPAIRFUNCTIONINCLUDEPARTICULATECONTAMINATION,CHEMICALDISCOLOURATIONSPOTSORLARGERAREAS,TOOLMARKS,NICKS,CHIPS,CAVITIESANDCRACKSCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISONOTFORRESALENOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO215342007E6ISO2007ALLRIGHTSRESERVED9STERILIZATION91GENERALTHEREQUIREMENTSOFCLAUSE9OFISO14630APPLYTOGETHERWITHTHEFOLLOWINGTHEEFFECTSOFTHESTERILIZATIONPROCESSSHALLNOTIMPAIRTHEINTENDEDPERFORMANCEOFTHEIMPLANTSEECLAUSE4AND721C,DANDFIMPLANTSCONTAININGUHMWPEANDSTERILIZEDBYIONIZINGRADIATION,SHALLNOTBESUPPLIEDFORCLINICALUSEIFANACCUMULATEDDOSEOFRADIATIONHIGHERTHAN40KGYHASBEENRECEIVEDTHISREQUIREMENTDOESNOTAPPLYIFRADIATIONINTENDEDTOIMPROVETHEMECHANICALCHARACTERISTICSOFTHEMATERIALISCOMBINEDWITHTHERADIATIONFORSTERILIZATIONPURPOSES92EXPIRYTHEMANUFACTURERSHALLCONDUCTANINV
人人文库> 全部分类> 教育资料 > 辅导培训

温馨提示

  • 1. 本站所有资源如无特殊说明，都需要本地电脑安装OFFICE2007和PDF阅读器。图纸软件为CAD,CAXA,PROE,UG,SolidWorks等.压缩文件请下载最新的WinRAR软件解压。
  • 2. 本站的文档不包含任何第三方提供的附件图纸等，如果需要附件，请联系上传者。文件的所有权益归上传用户所有。
  • 3. 本站RAR压缩包中若带图纸，网页内容里面会有图纸预览，若没有图纸预览就没有图纸。
  • 4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
  • 5. 人人文库网仅提供信息存储空间，仅对用户上传内容的表现方式做保护处理，对用户上传分享的文档内容本身不做任何修改或编辑，并不能对任何下载内容负责。
  • 6. 下载文件中如有侵权或不适当内容，请与我们联系，我们立即纠正。
  • 7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。

最新文档

评论

0/150

提交评论