ISO 046312023.docx

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1、INTERNATIONA1.STANDARDISO4631editionFirSt2023“1Corrosionofmeta1.sanda1.1.oys一Measurementofthee1.ectrochemica1.critica1.1.oca1.izedcorrosionpotentia1.(E-C1.CP)forTia1.1.oysfabricatedviaadditivemanufacturingmethodinsimu1.atedbiomedica1.so1.utionsCOPYRIGHTPROTECTEDDOCUMENTISO2023IUirhM*hedbdi1.iUedothe

2、rwiseupdhi.o啪InyM1.tta0DmkfifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.227490111觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsFnrpwnrdPageivIntroductionScone.V11.Normativereferences13Termsanddefinitions145Princip1.esJ35.1Potentiostat5.2Heatingbathwithtemperaturecontro1.1.er_.3363SQeCinttt0CIJC1.reCr

3、nCv.367.7esrvCT!ToderandCOnneetro1.TS5.5Auxi1.iarye1.ectrodeandreferencee1.ectrode4Testso1.utions.448Procedure8.1Preparationofreferencee1.ectrodess58.2Preparationofbiomedica1.AMTia1.1.oyspecimenS98.3PrepQgatiDntMEseiiQftQest8.5EndingtestExaminationandeva1.uation-.65610Teqrpnnrt7AnnexA11nrmative)Va1.

4、idityoftheE-C1.CPbythecorre1.ationbetveenE-C1.CPand98ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsthtiugh(ISOtchn0ibdni)t盟KWCekUWIMMpbringbodyIi1.tf1.raaMftandrittfowt1.rcarted)11mitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommit

5、tee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO.a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfu

6、rthermaintenanceare狐制岫1搬OfISO雇附胸IVeS输同加部间ter0rdanceJRhtheeditoria1.ru1.esoftheISO/IECDirectives.Part2(seewwwjso.org/dircc1.ives).而解熊nts)a%WMakeS幽嬲据i帆n冰腿榔精涵崛胸戚mm腑酶邺WMedaimedpatentrightsinrespectthereof.Asofthedateofpub1.icationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoim

7、p1.ementthisdocument.However,imp1.ementorsare懈怖翻琳躺/mj，wWjSOQFg/眸IentS洗蝮油那ion,扁所柏SPO虑袂岫油嬲部忸t躲Orasuchpatentrights.Anytradeusedinthisconstitutenameendorsenent.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand隘邈蛔

8、豳酒侬遮W即辆O)assEif1.眦聚inwe帼s宛嘛丸nBar泄机JSdead曲跳CS槐ur11isaorgiso/foreword.htmI.ThisdocumentwaspreparedbyTechnica1.CommitteeISO/TC1561.Corrosionofmeta1.sanda1.1.oys.AnyfeedbackorquestionsonthisdocumentShaUIdWdimU4U041.uwwnatkna1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.iso.org/members.h

9、tm1.IntroductionuniqueCombinationhavehighstrength,moreWidespread1.owerdensity,petingstain1.essstee1.s.andisWe1.1.thusestab1.ishedthatbiocompatib1.e.exce1.1.entCorrosionconventiona1.1.ymethodo1.ogyhasgainedWor1.dwidcofattcntionstar1.ing,waymateria1.costsandimproveefficiency.Comparingmanufactringprf1.

10、ucedbybecauseofunknown,parab1.etothoseresistanceconventiona1.1.ya1.1.oysStandardsbyshou1.dmethods.howthiseva1.ua1.ethemeasurement1.oca1.izedCorroSk)IW1.eCtnKhCmiCa1.method1.oca1.izedcorrosionpotentia1.temperatureScanintroducedtesting.Therefore,e1.ectrochemica1.ga1.vanostatic-potentiostaticpo1.arizat

11、ionprocessesande1.ectrochemica1.po1.arizationce1.1.isusedinthe2023-A1.1.rightsreservedTia1.1.oyssuchasTi-6AI-4Vareconsideredtobethemostpromisingbiomedica1.materia1.s.Duetoatheirapp1.icationsofbecome1.owmodu1.us,inawideandofindustries,e.g.aerospace,automobi1.e,marineandbiomedica1.fie1.ds.Especia1.1.y

12、themedica1.gradeTia1.1.oysarcimp1.antedinpatientswor1.dwideeveryyearanda1.sohaveasignificant1.yhigherstrengthtoweightratiothana1.1.bodyidsandtissueItarecomp1.ete1.yTia1.1.oysIiaveTheseTia1.1.oysareresistanceproducedbywroughtorcastprocesseswhicharethesubtractivemanufacturing(SM)methods,butrecent1.yth

13、enewadditivemanufacturing(AM)methodisemerging,ca1.1.ed3Dprinting*.ThisnewSMwithAM,therat100fthemasstherawtocutthemassofthefina1.,finishedpartcanbeashighas20:1.Intermsofmechanica1.viewpoint,bothstrengthandducti1.ityofTia1.1.oyssuchasTi-6AI-4VfabricatedbyAMarecomparab1.etoorabovetheirpropertiesmadebyc

14、onventiona1.ofTia1.1.oysmethods,AMissti1.1.theirUniquewhetherHowever,ofthecorrosionmanufacturedTia1.1.oysornot,becauseoftheirdefectssuchasporosity,theformationofmartensitephaseresu1.tingfromtherapidso1.idification,anddirectiona1.differencewiththestacking.Therefore.thenewroducedAMbemadeFortouse,resis

15、tancetomethodsuchasonstackedcritica1.1.oca1.izedco11osiontemperature(E-C1.CT)hasbeenadoptedasISO22910.However,atthevnorma1.rangesofpHandtemperaturescorrespondingtohumanbody,theuseofE-C1.CTmeasurementcritica1.shou1.dbe1.imitedbecauseofthe(EC1.CP)isnew1.yduringandproposedasnewcriterionfortheeva1.uatio

16、noftheresistancetothe1.oca1.izedcorrosiononthebiomedica1.AMTia1.1.oysinhumanbodyenvironments.Thisnewtestmethodiscontro1.1.edbypotentiostatthroughpotentiodynamic-artificia1.physio1.ogica1.f1.uids.Corrosionofmeta1.sanda1.1.oysMeasurementofthee1.ectrochemica1.critica1.1.oca1.izedcorrosionpotentia1.(E-C

17、1.CP)forTia1.1.oysfabricatedviaadditivemanufacturingmethodinsimu1.atedbiomedica1.so1.utions1 Scopeneasuringfabricatede1.ectrochemica)manufacturingcorrosionpotentia1.domentdefinesAMthemateria1.s2 Normativereferences3 TermsanddefinitionsISOandIECmaintaintermino1.ogydatabasesforuseinstandardizationatth

18、efo1.1.owingaddresses：3.1 IECE1.ectropedia:avai1.ab1.eathttp曰/wwv.HeCtrcPedir:Themorenob1.ethepotentia1.,thegreatertheresistanceto1.oca1.izedcorrosion.cyc1.icPotentiodynaniicpo1.arizationCPP3.3e1.ectrochemica1.critica1.1.oca1.izedcorrosiontemperatureE-C1.CT4Princip1.es(E-C1.CP)forphysio1.ogica1.corr

19、osionenvironments.reciprocatinganodicpo1.arization5.4Testce1.1.Thetestce1.1.sha1.1.containthetestspecimen,a1.uggincapi1.1.aryprobeconnectedtoanexterna1.otafagttCftQttedrgmeasdrkiRQtdd(ff1.11ibttpotgt1.thiyIr1.iybuHh1.iapff1.tsforthtnugh1.ditso1.ution.SeeFigure3.1 referencee1.ectrode2 bubb1.er3 e1.ec

20、tro1.yteFigure3SchematicdiagramofanE-C1.CPce1.1.5.5Auxi1.iarye1.ectrodeandreferencee1.ectrodeTheauxi1.iarye1.ectrodeispreparedfromhigh-purityp1.atinum1.argerthantheareaofthetestspecimen.dmTOfanioet4t3t)deshuiibemgnpd1.aMxhbRtfhwporacwo1.yusetrttomni矶isandthesaturatedca1.ome1.e1.ectrode.6Testso1.utio

21、nsForthetest,theartificia1.physio1.ogica1.f1.uidsareusedsuchasRinger,Hanksandsa1.ivaso1.utions7J*1皿it咖specimenfortheapp1.ication.RWaCeSSP於佃苗仲段三W沙田耐jb1.eWfeKMd删KdA*b1.三anP1.三f1.cu1.ar曲QrdMMI图M住Stthestackingdirection,dependingonthestackingdirectionviaAM.Aminimumtestvo1.umeof10mm10mm1mmorhighersha1.1.b

22、eused.A1.essthan20%rat100fsidearea(orrimarea)totota1.doub1.e-disti1.1.edwaterspecimeniswet-groundupto600-gritSiCpaper,c1.eanWithdeionizedwateror8Procedure8.1 Preparationofreferencee1.ectrodes8.2 Preparationbiomedica1.AMisgreaterSpccimcntheteste1.ectrodessha1.1.berejected.Thespecimensha1.1.beprepared

23、toensureareproducib1.esurfacefinish.8.3 takenPreparationcontaminateso1.utiontestsurfaceofthespecimen.TheSettingsha1.1.thepreparedusingreagent-gradechemica1.sandhigh-puritywater.ComPrjSeSmethOdfO1.kJWingJe1.erminctheE-C1.CPofAMTia1.1.oysintheenvironmentOfbioniedica1.so1.utionsso1.utions-so1.ution,the

24、artificia1.physio1.ogica1.f1.uidsareusedsuchasaRinger,Hanksorsa1.ivaTheE-C1.CPsha1.1.bemeasuredasfo1.1.ows:SMTia1.1.oysmaybeusedasacreviceassemb1.y.C)Currentpo1.arizationreachespertormediiAZcmzbypotentiostatequa1.izationmethodpotentia1.mV/secpotentia1.-d)constantcurrentdensity,densityreachesperforme

25、dcmho1.dingmethodatisimmediate1.ychangedtoItia1.constant1.hatpoIariZaUonisincreasee1.ectrodecurrentpotentia1.ofIOtheanodicdirectioncurrentdensityconstantobserved,theh.uncertaintyexistsconcerningWhether1.eastincreaseinareadesirab1.e.Testandair-dried.Thedifferenceinpotentia1.betweenthereferencee1.ectr

26、odeandtwootherva1.idatione1.ectrodessha1.1.bemeasured.IftheOfpotentia1.differenceTia1.1.oythan3mV,Thespecimensha1.1.bec1.eanedimmediate1.ypriortoimmersionintheso1.utionbydegreasing,rinsinginhigh-puritywater,fo1.1.owedbyethano1.orasimi1.arso1.ventandairdrying.Afterdegreasing,caresha1.1.beofthe8.4so1.

27、utionupbeE-C1.CPtestThetesttoThemeasuringapparatusconsistsofaPotentiO/ga1.vanostat,ane1.ectrochemica1.po1.arizationce1.1.FortestThetemperatureofthetestso1.utionis37,01ofhumanbodytemperature.a) Theshapeofthetestpieceistherectangu1.arsheettypewithoutacrevicepartThecreviceformerorcreviceassemb1.ysha1.1

28、notbeused.However,forthecomparisonpurpose,counterpartsuchasb) Thetestpieceisimmersedintotheso1.utionexceptfortheconnectionwirepartinthegasphase.Anodicdensityis500Withapotentia1.fromopencircuitof1unti1.anodicsweepve1.ocity.AftertheanodicCurrentandthetestis500by2,thefor2500Acmz.e)Inareverse(cathode)d

29、irection,afterho1.dingaconstantcunentdensityof500cnz,e1.ectrodetime.Whenanhe1.datofthedensityinmV1.owerthantheisobserved,aconstantpotentia1.ishe1.dagainatapotentia1.10mV1.owerthanthat.Thisoperationisrepeatedunti1.anincreaseintheanodicdirectionofthecurrentdensityisno1.ongerobservedbyho1.dingaisC1.ear

30、1.ypotentia1.for2Ifapp1.icationshou1.dkeepon.ho1.dingforatanthreetimesmoreatapotentia1.10mV1.owerthanthepresentpotentia1.Ifadearincreaseincurrentdensityisnotobservedanymore,thisindicatestheE-C1.CPisobtained.Otherwise,theoperationshou1.dherepeatedunti1.thepreciseE-C1.CPisre-eva1.uated.TheE-C1.CPforbi

31、omedica1.AMTia1.1.oysisdodtf)11g11dobythrtiyhigkortst,ahidmiHiftw2ihcfietsuthe4anodicdirectionofacurrentdensityisa)Typica1.proceduresofanE-C1.CPtestb)Correspondingphotographshowing1.ayer-by-1.ayercorrosionaftertestingKeyY1.currentdensity(Acm2)Y2potentia1.(Vsce)1 currentdensity2 potentia1.3 1.ayer-by

32、1.ayercorrosionFigure4DeterminationoftheE-C1.CPforbiomedica1.AMTia1.1.oysinRingerso1.utionNOTE1SomeE-CIXPva1.uescanbefoundinReference3J.NOTE2SomeE-C1.CPandE-C1.CTva1.uescanbefoundinReference4.8.5EndingtestThetestsha1.1.beterminatedwhentheE-C1.CPhasbeendetermined.WH*1市9*使ManhomaH(Uftpmcthan01s於IHIwn

33、WtVtmH电#trai1.edwithethano1.,rinsedThespecimensha1.1.beinspectedusinganoptica1.microscopetoconfirmwhetherpittingandcrevicecoU5Mitofiono(Qed.eva1.uation市Ave摩丽a1.1.sp啾Cbet&屿卡%ed屈thc三JuesQgjNgbeHWtdPrWfr兼1性械砧reofperformance.nta1.co评8曲WiVSge阚Va*歼相陶1.三ure,而空姐抬诬nu视ers三6蛤fensrequiredforAnneXshowstheva1.idi

34、tyofE-C1.CPbythecorre1.ationbetweenE-C1.CPandEC1.CT.Thetwoindividua1.testresu1.tscanbecomparedandeva1.uated.ISO2023-A1.1.rightsreserved10TestreportThetestreportsha1.1.inc1.udethefo1.1.owinginformation:a) areferencetothisdocument,i.e.ISO4631:2023;b) thetestso1.utionanditsvo1.ume；c) ar1.fiWW3hc。曲檎n,te

35、史格iftG厢M呢由ndyg曲taken,inc1.udingcompositiond)theorientationandsizeoftestspecimens；e)tfishsQW1.曲ng;Ofspecimens,inc1.udingthestoragetimebetweencarryingouttheHna1.surface0thetestareaandtheminimumthickness;g) thee1.ectrodepotentia1.;h) adescriptionofthespecimensurfaceaftertesting;i) theE-CIXP;j) endingpo

36、tentia1.;k) deviationoftestresu1.tsfromtheprocedure;l) unusua1.featuresobserved;m) areferencetoexp1.aintheca1.cu1.ationoftheresu1.ts；n)thedateofthetest.AnnexA(informative)Va1.idityoftheE-C1.CPbythecorre1.ationbetweenE-C1.CPandE-C1.CTKey2 E-CIXT(25wt%NaCI12.8Vsc.r.)3 E-C1.CP(ringerso1.ution,37)4 E-C1

37、CP(3,5wt%NaC1.,50)1.oca1.izedcorrosiondoesnotoccur.NOTEE-C1.CTtestforAMTi-6A1.-7Nbwasperformedattheapp1.iedpotentia1.of3f4Vsce.FigureA.1.Comparisonbetweenva1.uesOfE-C1.CT(ISO22910)andEC1.CP(ISOPW1.4631)ofa1.1.oysfabricatedviaadditivemanufacturingTodemonstratetheva1.idityOfE-C1.CPtestsofMTia1.1.oys,

38、theE-C1.CPva1.uesobtainedwerecomparedda1.B0G&6HCTRn辍Muc)CTHByataAMTi-6A1.-7NbAMTi-6A1-4VAMNi718a1.1.oysinresistanceagainstthe1.oca1.ized由叫鲁蝴氏Ther部岫崛龙烟晶9腑I。用假糊taMM&a1.1.o朝腼跳阳P联砒视删硼Bib1.iography1转W明价酬(蒯/。解或砌吧。的物肌册附照皆例,d陶窗的的阀俑斯加/孤肋ZCd12)?8(4W,喃明物都i蝴P界例HR郎9皿植秋崛Kg琳加陷Ewi电刑贿一Guide1.inesfor3 1.eeJ.-B.zSeoD.

39、I,ChangH.-Y.,Eva1.uatingCorrosionResistanceofBiomedica1.Ti-6AI-4VA1.1.oysfWkti0dNinMdtttfd)t20iira21.7i(jBSR359E1.ectrochemica1.Critica1.1.oca1.izedCorrosion4 SeoD.I.r1.eeJ.-B.,1.oca1.izedCorrosionResistanceonAdditivc1.yManufacturedTiA1.1.oysRXJ铝11ftSXts.触腕2府洌k?怒Iq建斛J)SiOnPotentia1.inBiomedica1.So1.utionISO2023-A1.1.rightsreserved