EN ISO 14630-1997 金属和合金的腐蚀 点蚀评定方法

'SUOMENSTANDARDISOIMISLIITTOSFSSTANDARDISFS-ENISO14630LääkelaitosVahvistettuTheNationalAgencyforMedicines1998-03-301(1+15)COPYRIGHT©SFS.OSITTAINENKINJULKAISEMINENJAJÄLJENTÄMINENSALLITTUVAINSFS:NLUVALLA.TÄTÄSTANDARDIAMYYSUOMENSTANDARDISOIMISLIITTOTämästandardionvahvistettuenglanninkielisenäThisstandardisapprovedinEnglish.EI-AKTIIVINENKIRURGINENIMPLANTTI.YLEISETVAATIMUKSETNon-activesurgicalimplants.GeneralrequirementsTämästandardisisältääeurooppalaisenstandardinENThisstandardconsistsoftheEnglishtextoftheISO14630:1997”Non-activesurgicalimplants.GeneralEuropeanStandardENISO14630:1997”Non-activerequirements(ISO14630:1997)”englanninkielisensurgicalimplants.Generalrequirements(ISOtekstin.14630:1997)”.EurooppalainenstandardiENISO14630:1997onTheEuropeanStandardENISO14630:1997hasthevahvistettusuomalaiseksikansalliseksistandardiksi.statusofaFinnishnationalstandard.SUOMENSTANDARDISOIMISLIITTOSFSryHELSINKIFINNISHSTANDARDSASSOCIATIONSFSSFS01-05 EUROPEANSTANDARDENISO14630NORMEEUROPÉENNEEUROPÄISCHENORMNovember1997ICS11.040.40Descriptors:medicalequipment,surgicalimplants,specifications,performance,sterilization,marking,packaging,generalitiesEnglishversionNon-activesurgicalimplants–Generalrequirements(ISO14630:1997)Implantschirurgicauxnonactifs–ExigencesNichtaktivechirurgischeimplantate–Allgemeinegénérales(ISO14630:1997)AnforderungenISO14630:1997)ThisEuropeanStandardwasapprovedbyCENon4July1997.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom.CENEuropeanCommitteeforStandardizationComitéEuropéendeNormalisationEuropäischesKomiteefürNormungCentralSecretariat:ruedeStassart36,B-1050BRUSSELS©1997CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembersRef.No.ENISO14630:1997E Page2ENISO14630:1997ContentsPageForeword............................................................................................................3Introduction.......................................................................................................41Scope........................................................................................................42Normativereferences...............................................................................43Definitions................................................................................................54Intendedperformance..............................................................................65Designattributes......................................................................................66Materials..................................................................................................77Designevaluation.....................................................................................78Manufacture.............................................................................................89Sterilization..............................................................................................810Packaging.................................................................................................811Informationsuppliedbythemanufacturer...............................................9AnnexA(informative)Bibliography..............................................................10AnnexB(informative)ClausesofthisEuropeanStandardaddressingrequirementsorotherprovisionsofEUDirectives...........................................13 Page3ENISO14630:1997ForewordThetextofENISO14630:1997hasbeenpreparedbyTechnicalCommitteeCEN/TC285“Non-activesurgicalimplants”,thesecretariatofwhichisheldbyNNI,incollaborationwithTechnicalCommitteeISO/TC150"Implantsforsur-gery".ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyMay1998,andconflictingnationalstandardsshallbewithdrawnatthelatestbyMay1998.ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s).TherearethreelevelsofEuropeanStandardsdealingwithnon-activesurgicalimplants.Theseareasfollows,withlevel1beingthehighest:-level1:Generalrequirementsfornon-activesurgicalimplants;-level2:Particularrequirementsforfamiliesofnon-activesurgicalimplants;-level3:Specificrequirementsfortypesofnon-activesurgicalimplants.Thisstandardisalevel1standardandcontainsrequirementsthatapplytoallnon-activesurgicalimplants.Italsoindicatesthatthereareadditionalrequire-mentsinthelevel2andlevel3standards.Thelevel2standardsapplytoamorerestrictedsetorfamilyofimplantssuchasthosedesignedforuseinosteosynthesis,cardiovascularsurgery,orjointreplace-ment.Thelevel3standardsapplytospecifictypesofimplantswithinafamilysuchashipjointsormammaryimplants.AllEuropeanStandardscurrentlyavailableorinpreparationarelistedinthebibliography(seeAnnexA).Toaddressallrequirements,itisnecessarytostartwithastandardofthelowestavailablelevel.ReferencestootherEuropeanorInternationalStandardscanalsobefoundinAnnexA"Bibliography".ForrelationshipwithEUDirective(s),seeinformativeAnnexZB,whichisaninte-gralpartofthisstandard.NOTE.TheEuropeanStandardslistedinthebibliographyhavenotbeenadoptedasIn-ternationalStandardsinallcases(seealsonotesinIntroductionandclause2).AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnitedKingdom. Page4ENISO14630:1997lntroductionThisEuropeanStandardprovidesamethodtodemonstratecompliancewiththerelevantessentialrequirementsasoutlinedingeneraltermsinAnnex1oftheCouncilDirective93/42/EECof14June1993concerningmedicaldevices,astheyapplytonon-activesurgicalimplants,hereafterreferredtoasimplants.Italsopro-videsamethodofaddressingthefundamentalprinciplesoutlinedinISO/TR14283,astheyapplytononactivesurgicalimplants.Forsuchproducts,particularandspecificrequirementsmayapply.Theseaddi-tionalrequirementsarespecifiedinthelevel2and3standardsortheirparts.NOTE:Thestructureofthisstandardandthenormativereferencesofthisstan-dardarebasedontheuseofthestandardinsupportingCouncilDirective93/42/EEC.FortheEuropeanStandardslistedinthenormativereferences(seeclause2),insomecasesInternationalStandardsareavailable(seealsoclause2,NOTE1).UsersofInternationalStandardsshouldbeawarethattheymaynotnecessarilymeettheessentialrequirementsoftheCouncilDirective93/42/EECorotherregulatoryrequirementsforothercountriesorregions.1ScopeThisEuropeanStandardspecifiesgeneralrequirementsfornon-activesurgicalimplants.Thisstandardisnotapplicabletodentalimplants,dentalrestorativematerials,transendodonticandtransradicularimplantsandintraocularlenses.Withregardtosafety,thisstandardgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacture,sterilization,pack-agingandinformationsuppliedbythemanufacturer,andtests.Testsrequiredtobeusedtodemonstratecompliancewiththisstandardarecon-tainedinotherlevels.2NormativereferencesThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromotherpublications.Thesenormativereferencesarecitedattheappropriateplacesinthetextandthepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoorrevisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthepublicationreferredtoapplies.EN540Clinicalinvestigationsofmedicaldevicesforhumansubjects.EN550Sterilizationofmedicaldevices–Validationandroutinecontrolofethyleneoxidesterilization.EN552Sterilizationofmedicaldevices–Validationandroutinecontrolofsterilizationbyirradiation.EN554Sterilizationofmedicaldevices–Validationandroutinecontrolofsteamsterilizationbymoistheat.EN556Sterilizationofmedicaldevices–Requirementsformedicaldeviceslabelled"Sterile".EN868-1Packagingmaterialsforsterilizationofwrappedgoods–Part1:Generalrequirementsandrequirementsforthevalidationofpack-agingforterminallysterilizeddevices. Page5ENISO14630:1997EN980Terminology,symbolsandinformationprovidedwithmedicaldevices–Graphicalsymbolsforuseinthelabellingofmedicaldevices.prEN1041Terminology,symbolsandinformationprovidedwithmedicaldevices–Informationsuppliedbythemanufacturerwithmedicaldevices.prEN1441Medicaldevices–Riskanalysis.prENISO10993-1Biologicalevaluationofmedicalanddentalmaterialsanddevices–PartI:Guidanceonselectionoftests.NOTE1:ForsomeoftheEuropeanStandardslistedinthisclause,anidenticalortechni-callyrelatedInternationalStandardsisavailable.TheseInternationalStandardsarelistedinA.3.NOTE2:AnnexA"Bibliography"summarizesinformativereferencestootherpartsofthisstandardandotherEuropeanStandards,aswellasinformativereferenceswhicharecitedinthetext.3DefinitionsForthepurposesofthisEuropeanStandardthefollowingdefinitionsapply.3.1non-activesurgicalimplantImplantabledevicewhichisnotanactivemedicaldevice.3.2implantabledeviceDevicewhichisintended:tobetotallyintroducedintothehumanbodyor,toreplaceanepithelialsurfaceorthesurfaceoftheeye,bysurgicalinterventionwhichisintendedtoremaininplaceaftertheprocedure.Anymedicaldeviceintendedtobepartiallyintroducedintothehumanbodythroughsurgicalinterventionandintendedtoremaininplaceaftertheprocedureforatleast30daysisalsoconsideredanimplantabledevice.3.3activemedicaldevice.Medicaldeviceoperationofwhichdependsonasourceofelectricalenergyoranysourceofpowerotherthanthatdirectlygeneratedbythehumanbodyorgravityandwhichactsbyconvertingthisenergy.Medicaldevicesintendedtotransmitenergy,substancesorotherelementsbetweenanactivemedicaldeviceandthepatient,withoutanysignificantchangearenotconsideredtobeactivemedicaldevices.3.4safetyFreedomfromunacceptableriskofharm.3.5implantablestateConditionofanimplantpreparedforimplantationintoahumansubject.3.6leakageUnintendedmovementoffluidincludingbodyfluidsintooroutofimplantsthroughadefectinthestructureofthecontainingwall.3.7coatingLayerofmaterialusedtocoverorpartiallycoverasurfaceofanimplant. Page6ENISO14630:19974IntendedperformanceTheintendedperformanceofanimplantshallbedescribedanddocumentedbyaddressingthefollowing:-functionalcharacteristics;-typicalintendedapplications;-intendedconditionsofuse;-withparticularregardtosafety.NOTE:Accountshouldbetakenof:-publishedstandards;-publishedclinicalandscientificliterature;-validatedtestresults.5DesignattributesThedesignattributestomeettheintendedperformanceshalltakeintoaccountatleastthefollowing:a)materialsandtheirbiocompatibility(seeclause6);b)physical,mechanicalandchemicalpropertiesofmaterials,includingendur-ancepropertiesandageing(seeclauses6and7);c)wearcharacteristicsofmaterialsandtheeffectsofwearandwearproductsontheimplantandthebody(seeclauses6and7);d)effectofmanufacturingprocesses(includingsterilization)onmaterialcharac-teristicsandperformance(seeclauses6,7,8and9);e)possibleeffectsontheimplantanditsfunctionduetointeractionsbetweenitsconstituentmaterialsandothermaterialsandsubstances(seeclauses6and7);f)extentandeffectofleakageand/ordiffusionofsubstancesusedtofillimplants(seeclauses6and7);g)interconnectionsandtheireffectsontheintendedperformance(seeclause7);h)interface(s)betweentheimplantandbodytissue(s),particularlyrelativetofixationandconnection,andsurfaceconditions(seeclause7);i)shapeanddimensionsincludingtheirpossibleeffectsontissuesandbodyfluids(seeclause7);j)biocompatibilityoftheimplantinitsimplantablestate(seeclauses6and7);k)physicalandchemicaleffectsofthebodyandexternalenvironmentontheimplant(seeclause7);l)effectsofradiationandelectromagneticfieldsontheimplantandconsequen-tialeffectsonthebody(seeclauses6.1and7);m)abilitytoimplant,toremoveandtoreplacetheimplantafterimplantation(seeclause7);n)microbiologicalandparticulatecontaminationlevels(seeclauses8,9and10);o)suitabilityandeffectivenessofpackaging(seeclause10). Page7ENISO14630:1997Implantdesignattributesshallbedocumented.Whereanyoftheabovedesignattributesarenotconsideredtobeapplicable,thereasonshallbedocumentedandjustified.6MaterialsMaterialsforthemanufactureofimplantsshallbeselectedwithregardtothepropertiesrequiredfortheintendedpurpose,takingintoaccounttheeffectsofmanufacture,handling,sterilizationandstorage.Possiblereactionsofimplantswithhumantissuesandbodyfluids,othermaterials,otherimplants,substances,gases,radiationandelectromagneticfieldsshallbeconsidered(seeclause7).Whenamedicinalproductisanintegralpartofanimplant,themedicinalproductshallbeassessedaccordingtopharmaceuticalprinciples.Theperformanceofthemedicinalproductusedincombinationwiththeimplantshallnotbeaffectedbytheimplantand/orvisaversa.NOTE1:ForcomplyingwiththeprovisionsoftheEuropeanCouncilDirective93/42/EECof14June1993concerningmedicaldevices,thesafety,qualityandusefulnessoftheme-dicinalproductshouldbeverified,takingintoaccountoftheintendedpurposeoftheim-plantbyanalogywiththeappropriatemethodsspecifiedinDirective75/318/EEC.Materialsusedforimplantsandcoatings,includingbiologicalmaterialsproducedbygeneticengineering,shallbeacceptablycompatibleintheirimplantablestate.Thecompatibilityofpossiblewearanddegradationproductsshallalsobeaccept-able.Theacceptabilityintheparticularapplicationshallbedemonstratedeither:a)bydocumentedassessmentinaccordancewiththeprinciplesofprENISO10993-1or,b)byselectionfromthematerialsfoundsuitablebyprovenclinicaluseinsimilarapplications.NOTE2:Someofthelevel2standardsincludelistsofmaterialswhichhavebeenfoundacceptableincertainapplications.NOTE3:Implantsutilizingmaterialofanimaloriginshouldbeevaluatedwithregardtohazardsarisingfromthepotentialfortransmissionofinfectiousagents,inparticularnon-bacterialandnon-viralagents.Standardsformedicaldevicesutilizinganimaltissuesareinpreparation(seeannexA.2).7Designevaluation7.1GeneralImplantsshallbeevaluatedtodemonstratethattheintendedperformance(seeclause4)isachieved.Theextenttowhichtheintendedperformancehasbeenachievedshallbedeterminedanddocumented.Safetyshallbedemonstratedbypre-clinicalandclinicalevaluation,includinganappropriateriskanalysisinac-cordancewithprEN1441.7.2Pre-clinicalevaluationImplantsshallundergopre-clinicalevaluationby:a)acompilationandcriticalanalysisofrelevantscientificliterature;and/orb)analysisofdataobtainedfromtesting.Pre-clinicaltestingofimplantsshallsimulateconditionsofintendeduse.Testmethodsandrelatedacceptancecriteriaforspecifictypesofimplantsarerefer-encedinotherpartsofthisstandard. Page8ENISO14630:19977.3ClinicalevaluationImplantsshallundergoclinicalevaluationby:a)acompilationandcriticalanalysisofrelevantscientificandclinicalliteraturecoveringtheintendeduseoftheimplantorsimilarimplants;and/orb)analysisofdataobtainedfromclinicalinvestigation.WhereaclinicalinvestigationiscarriedoutitshallbemanagedinaccordancewiththerequirementsofEN540.Requirementsforclinicalinvestigationofspe-cificproducttypesareincludedinotherpartsofthisstandard.8ManufactureImplantsshallbemanufacturedinsuchawaythatthespecifieddesignattributesareachieved.Requirementsarespecifiedinotherpartsofthisstandard.NOTE:TheapplicationofqualitysystemsasdescribedinEN46001andEN46002maybeappropriate(seeannexA.2).9Sterilization9.1ProductssuppliedsterileImplantswhicharelabelled“STERILE”shallcomplywithEN556.-6NOTE:EN556:1995requiresasterilityassurancelevelof10.Sterilizationprocessesshallbevalidatedandroutinelycontrolled.Ifimplantsaretobesterilizedbyethyleneoxide,EN550shallapply.Ifimplantsaretobesteril-izedbyirradiation,EN552shallapply.Ifimplantsaretobesterilizedbysteam,EN554shallapply.9.2Productssuppliednon-sterileForimplantswhicharesuppliednon-sterile,themanufacturershallspecifyatleastoneappropriatemethodofsterilisationsuchthatthefunctionalsafetyoftheimplantisnotadverselyaffected.Ifmultiplesterilizationsarenotallowedthisshallbestatedintheinformationprovidedbythemanufacturer(seeclause11).9.3SterilizationresidualsTestingforresidualsofsterilizationshallbeinaccordancewiththeprinciplessetoutinprENISO10993-1.Thelevelsofresidualsshallnotexceedthelimitsspeci-fiedintheappropriatepartsofEN/ISO10993(seeannexA.2).10Packaging10.1ProtectionfromdamageinstorageandtransportForeachimplant,thepackagingshallbedesignedsothat,underconditionsspeci-fiedbythemanufacturerforstorage,transportandhandling(includingcontroloftemperature,humidityandambientpressure,ifapplicable),itprotectsagainstdamageanddeteriorationanddoesnotadverselyaffecttheimplant.NOTE1:TestmethodsgiveninEN60068-2-27,EN60068-2-32and/orEN60068-2-47maybeappropriate,seeannexA.2.NOTE2:Beforeanymethodofpackagingisadopted,itshouldhavebeenevaluatedtoestablishitssuitabilityfortheintendedpurpose.Thismaybedonebyhazardjourneytrialsdesignedtosimulatetheabusethepackagewillencounter. Page9ENISO14630:199710.2MaintenanceofsterilityintransitImplantslabelled"STERILE"shallbepackagedsothattheyremainsterileundernormalstorage,transportandhandlingconditionsunlessthepackagewhichmaintainssterilityisdamagedoropened.ThepackagingshallcomplywithprEN868-111Informationsuppliedbythemanufacturer11.1GeneralInformationsuppliedbythemanufacturershallbeinaccordancewithprEN1041Ifsymbolsareused,theyshallbeinaccordancewithEN980.Ifmultiplesterilizationsarenotallowed,thisshallbestatedintheinformationprovidedbythemanufacturer.11.2RestrictionsoncombinationsIftheimplantisintendedtobeusedincombinationwithotherimplantsorde-vices,anyrestrictionsintheuseofthecombinationshallbestatedonthelabelorintheinstructionsforuse/manual.11.3MarkingonimplantsImplantsshallbemarkedwiththefollowing:-manufacturer"snameortrademark;-batchcode(lotnumber)orserialnumber.Ifthemarkingwouldeffecttheintendedperformance,ortheimplantistoosmallorthephysicalpropertiesoftheimplantpreventlegiblemarking,theinformationrequiredshallbegivenonthelabelorbyothermeanstoprovidetraceability. Page10ENISO14630:1997AnnexA(informative)BibliographyA.1ListofotherpartsofthisEuropeanStandardA.1.1Level1standardsprEN12011Instrumentationtobeusedinassociationwithnon-activesurgicalimplants.GeneralrequirementsA.1.2Level2standardsprENxxxxxxNon-activesurgicalimplants–Bodycontouringimplants–Particularrequirements(incourseofpreparation)prEN12006-1Non-activesurgicalimplants–Particularrequirementsforcardiacandvascularimplants–PartI:HeartvalveprosthesesprEN12006-2Non-activesurgicalimplants–Particularrequirementsforcardiacandvascularimplants–Part2:Vascularprosthesesin-cludingcardiacvalveconduitsprEN12006-3Non-activesurgicalimplants–Cardiacandvascularimplants.Particularrequirements–Part3:VascularstentsandvenacavafiltersprEN12010Non-activesurgicalimplants–Jointreplacementimplants–ParticularrequirementsprENISO14602Non-activesurgicalimplants–Implantsforosteosynthesis.–Particularrequirements.A.1.3Level3standardsprEN12180Non-activesurgicalimplants–Bodycontouringimplants–SpecificrequirementsformammaryimplantsprEN12563Non–activesurgicalimplants–Jointreplacementimplants–SpecificrequirementsforhipjointreplacementimplantsprEN12564Non–activesurgicalimplants–Jointreplacementimplants–SpecificrequirementsforkneejointreplacementimplantsA.2ListofEuropeanStandards,referencedinthisstandard–generalENISO10993-7Biologicalevaluationofmedicaldevices–Part7:Ethyleneox-idesterilizationresiduals(ISO10993-7.1995)EN46001Qualitysystems–Medicaldevices–ParticularrequirementsfortheapplicationofEN9001EN46002Qualitysystems–Medicaldevices–ParticularrequirementsfortheapplicationofEN9002EN60068-2-27Basicenvironmentalprocedure.Part2:Tests–TestEaandguidance:ShockEN60068-2-32Basicenvironmentalprocedure.Part2:Tests–TestEdFreefallEN60068-2-47Basicenvironmentalprocedure.Part2.–Tests–Mountingofcomponents,equipmentandotherarticlesfordynamictestsin-cludingshock(Ea),bump(Eb),vibration(FcandFd)andsteadystateacceleration(Ga)andguidance Page11ENISO14630:1997prEN12442-1Animaltissuesandtheirderivativesutilizedinthemanufac-tureofmedicaldevices–Part1:AnalysisandmanagementofrisksprEN12442-2Animaltissuesandtheirderivativesutilizedinthemanufac-tureofmedicaldevices–Part2:Sourcing,controls,collectionandhandlingprEN12442-3Animaltissuesandtheirderivativesutilizedinthemanufac-tureofmedicaldevices–Part3:Eliminationand/orinactiva-tionofvirusesandothertransmissibleagents–Determinationofnon-viability Page12ENISO14630:1997A.3ListofNormativereferencedEuropeanStandardsandrelatedISOStandardsAtthetimeofpublicationofthisstandardthefollowingISOstandardswerecon-sideredtobeidentical(listedinA.3.1)ortechnicallyrelated(A.3.2).A.3.1IdenticalEuropeanStandardInternationalStandardprENISO10993-1ISO/DISBiologicalevaluationofmedicaldevices–10993-1Part1:EvaluationandtestingprENISO10993-7ISO10993-7Biologicalevaluationofmedicaldevices–Part7:Ethyleneoxidesterilizationre-sidualsEN60068-2-27IEC68-2-27Environmentaltesting.Part2:Tests–TestEaandguidance:ShockEN60068-2-32IEC68-2-32Basicenvironmentaltestingprocedure.Part2:Tests–TestEdFreefallEN60068-2-47IEC68-2-47Basicenvironmentaltestingprocedure.Part2:Tests–Mountingofcomponents,equipmentandotherarticlesfordy-namictestsincludingshock(Ea),bump(Eb),vibration(FcandFd)andsteadystateacceleration(Ga)andguidanceA.3.2TechnicallyrelatedEuropeanStandardInternationalStandardEN540ISO/DIS14155ClinicalinvestigationofmedicaldevicesEN550ISO11135Medicaldevices–ValidationandroutinecontrolofethyleneoxidesterilizationEN552ISO11137Sterilizationofhealthcareproducts–Requirementsforvalidationandroutinecontrol–RadiationsterilizationEN554ISO11134Sterilizationofhealthcareproducts–Requirementsforvalidationandroutinecontrol–Industrialmoistheatsteriliza-tionEN46001ISO/DIS13485Medicaldevices–Particularrequire-mentsfortheapplicationofISO9001EN46002ISO/DIS13488Medicaldevices–Particularrequire-mentsfortheapplicationofISO9002prEN1441CD14971Medicaldevices–Riskmanagement–ApplicationofriskanalysistomedicaldevicesA.3.3InternationalStandardsusefulfornonEUmemberISOTitleISO/TR14283Implantsforsurgery–Fundamentalrequirements Page13ENISO14630:1997AnnexB(informative)ClausesofthisEuropeanStandardaddressingessentialrequirementsorotherprovisionsofEUDirectives.ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociationandsupportsessentialrequirementsofEUDirective92/42/EECof14Juneconcerningmedicaldevices.WARNING:OtherrequirementsandotherEUDirectivesmaybeapplicabletotheproductsfallingwithinthescopeofthisstandard.TheFollowingClausesofthisstandardarelikelytosupportrequirementsofDi-rective93/42/EECof14Juneconcerningmedicaldevices.CompliancewiththeclausesofthisstandardprovidesonemeansofconformingwiththespecificessentialrequirementsoftheDirectiveconcernedandassociatedEFTAregulations. Page14ENISO14630:1997TableB.1Clause/sub-Correspondingan-Commentsclauseofthisnexes/paragraphsofEuropeanDirective93/42/EECStandard41–2–4–7.1Therequirementisneededinordertofulfilclauses5,6and7.Theactualtestingoftheimplantiscoveredinclauses6and7.51–2–3–4–5–7.1–Forthefinaldesign,itisrequiredtoestab-7.2–7.3–7.5–7.6–8–lishtheattributes.Thelistgiveninthestan-9.1–9.2dardidentifiessomeofthecriticalfactors.Level2and3standardsaddadditionalat-tributes.Furtherrequirementsandtestingarecoveredbyotherclauses.61–2–7.1–7.2–7.3–Clause6offersachoiceoftwomainroutes7.4–7.5–8.2–9.2fortheevaluationofbiocompatibilityofma-terials.Materialsofprovenusedonotneedtoundergofullscalebiocompatibilitytesting.Suchtestingisonlyrequiredfornewmateri-alsormaterialsinnewapplications.Refer-enceismadetoprEN10993-1.Furthermore,referenceismadetoclause7fortesting.Guidanceisgiventostandardsformedicaldevicesutilizinganimalmateri-als.71–2–3–4–6–7.1–Clause7requiresmanufacturerstodemon-7.2–7.3–7.5–7.6–8–stratetheattainmentoftheintendedper-9.1–9.2–14formanceasdefinedinclause4.Theclauseidentifiestwomainphasesintheevaluationofnewdesigns:preclinicalandclinicalevaluation.Thestandarddoesnotspecifytestmethodsoracceptancecriteria.InlevelIIstandardsfurtherrequirementsandtestingisspecified.Inthosecaseswherethereisconsensus,ac-ceptancecriteriahavebeenestablished.Inothercasescriteriacanonlybedefinedoncasebycasebasis.Theuseofstandardizedtestmethodsshouldensurethatcomparableresultsareobtained.ThestandardreferstoEN540inordertoensureuniformmanagementofclinicalin-vestigations.Thedetailsontheremitoftheinvestigations(numberofpatients,numberofinstitutions,durationetc.)havetobede-terminedonacasebycasebasis,dependingonthetypeofimplantsunderinvestigationandrisksexpected.(continued) Page15ENISO14630:1997TableB.1(concluded)81–2–3–5–7.1–7.2NormativereferencescannotbemadetoEN46001andEN46002oranyotherqualitysystemsincethechoicewhetherornottouseaqualitysystemaspartoftheconformityassessmentprocedureisopentothemanu-facturer.91–2–7.2–8–8.1–8.3EN556specifiesaparticularvalueofthe–8.4sterilityassurancelevel(SAL)whichisap-plicabletoallterminallysterilizedmedicaldevicesincludingnon-activesurgicalim-plants.Anappropriatesterilizationmethodisac-ceptableprovidedthatithasbeenvalidatedanditisroutinelycontrolled.ForthosemethodswhereEuropeanstandardsareavailable,thesearenormativelyreferenced.101–2–3–5–7.2–8–InformativereferencetoEN60068-2-27,8.3–8.4EN60068-2-32,prEN60068-2-47.111–2–8.7–13.1ReferencetoEN980andprEN1041.'