ISO 283992021.docx

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1、INTERNATIONA1.STANDARDISO28399editionThird202103DentistryExterna1.toothb1.eachingproductsMedecinebuccodentaireProduitsdc1.aircissementdentaireparvoteexterneOISO2021COPYRIGHTPROTECTEDDOCUMENTISO2021岫rkdea/山thUcdOthcnviscjftc三orrtmcehDVBiwixuioiti08phnn11UatiocBhrhotocp)Mng,ptbcatonpostingontheinterne

2、toranintranet,withoutpriorwrittenpermission.PermissioncanherequestedfromeitherISOattheaddressbe1.oworISni)rhuceiwHPfff1.PbbGgbOdyhIrf1.nmwbtandrikfowhtdIyuHmedmitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwi

3、thISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceare蜩魄他搬OfISO1.EC(陶曲俺照就杷Wt阳靛蜘解向N螂牌耐r%cordancetheeditoria1.ru1.e

4、softheISO/IECDirectives.Part2(secwww.iso.org/direc1.ives).Mionrigbtsd限的n隔嗯/阳网扁SI矗盛出飘剂能颗府加闻瞅棉如鼠蹦服ssubjectofanypatentrightsidentifiedduringthedeve1.opmerUW4iewmwVw1.1.beintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(seewww.iso.org/pa1.ents).Anytradeusedinthisconstitutenameendorsemen

5、t.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand稣牌U咽现dwan瞪WMw0)assE施。配制曲icnBa曲豳宙fdeaA禧ce恩vvw.iso.orgiso/forewod.htmI.辎则胸asJ8的杵曲邨抑ee1.ffittee5R硒1.izationSUiW而“他Gnica1.CommitteeCEN/TC55,Dentistry,inaccordanc

6、ewiththeAgreementontechnica1.cooperationbetweenISOandCEN(ViennaAgreement).版乐曲B袍川9H件的kH94dghfrW)MeditftVfi(99:2020),whichhasbeeneditoria1.1.ynTEMhasbeenremovedfromTEMgridthroughoutthisthirdedition;B.10.2.6EXMP1.Ehasbeenrewritten;mB.9A)hasbeenrep1.acedwithB.9”;一,Sce4we-9Bmhasbeenremoved;*1.nFigureB.9C

7、theva1.ueis51,9163(i.e.51,9VmrhaSbeenremovedandFigureB.9,k),numberofhasbeenrep1.acedwithwidthin;InC.3.3.3,EMhasbeenaddedinthespacebetweentwocommas.Anyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheuser,snationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.4so.erg/mefnbeFSrh

8、tm1.IntroductionExterna1.toothb1.eachingp11)ductsareusedindentistryforchangingtheco1.ourofnatura1.teethtowardsa1.ighterorwhitershade.Theyareapp1.iedintheora1.cavitydirect1.yontheoutersurfacesofteeth.Specificqua1.itativeandquantitativerequirementsforfreedomfrombio1.ogica1.hazardarenotinc1.udedinthisd

9、ocumentReferenceshou1.dbemadetoISO10993-1andISO7405whenassessingpossib1.ebio1.ogica1.ortoxico1.ogica1.hazards.Dentistry-Externa1.toothb1.eachingproducts1ScopeTheseb1.eachingproducts)orConSUmerapp1.icationcavity,(PrOfeSSiona1.non-professiona1.hfme(in-officeThisdocumentisnotapp1.icab1.etotoothb1.eachi

10、ngproducts：intendedrestorativeapproaches,suchasveneersteethcrownsmechanica1.methods(e.g.stainremova1.)thatareusedinconjunctionwiththeb1.eachingproducts.NOTECoUntryregU1.atOryConCentratiOnOfab1.eachingagentforprofessiona1.ornon-professiona1.useissubjectto2Normativereferencesconstitutesrequirenents1.a

11、testeditiondocument.referencedreferences,(inc1.udingamendments)app1.ies.app1.ies.ISO1942,DentistryVocabu1.aryISO6344-1,CoatedabrasivesGrainsizeana1.ysisPart1：GrainsizedistributiontestISO8601-2,DateandtimeRepresentationsforinformationinterchangePart2:ExtensionsISO11664-2,Co1.orimetryPart2:C1.Estandar

12、dH1.uminantsMateria1.s3TermsanddefinitionsISOandIECmaintaintermino1.ogica1.databasesforUSeinStandardiZatiOnatthefo1.1.owingaddresses:1Thisdocumentspecifiestherequirementsandtestmethodsforexterna1.toothb1.eachingproducts.toothproductsareintendedforintheora1.eitherbyapp1.icationusetoothb1.eachingprodu

13、cts),orboth.Ita1.sospecifiesrequirementsfortheirpackaging,1.abe1.1.ingandmanufacturersinstructionsforuse.-SpedfiedinISO11609;orusingchangeco1.ourperceptionofnatura1.orbyauxi1.iaryorsupp1.ementarymateria1.s(e.g.traymateria1.s)andinstrumentsordevices(e.g.1.ights)Thisdocumentdoesnotspecifybio1.ogica1.s

14、afetyaspectsoftoothb1.eachingproducts.each,sMaximumbody.Thefo1.1.owingdomentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,theofthisoftheFordateddocumenton1.ytheanyeditioncitedForISO1042,1.aboratoryg1.asswareOne-markvo1.umetricf1.asksISO3696,Waterforana1.ytica1.1.abo

15、ratoryuseSpecificationandtestmethodsISO8601-1.zDateandtimeRepresentationsforinfonnadoninterchangePart1：Basicru1.esISO/CIE11664-1.rCo1.orimetryPart1:CIEstandardco1.orimetricobserversANSI/ADASpecificationNo41:RecommendedStandardPracticesforBio1.ogica1.Eva1.uationofDenta1.Forthepurposesofthisdocument,t

16、hetermsanddefinitionsgiveninISO1942andthefo1.1.owingapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps:/www.iso.org/obp31.IECE1.ectropedia:avai1.ab1.eathttp;/WWW,HeEopediaQfg/b1.eachingremova1.ofintrinsicoracquireddisco1.orationsofnatura1.teeth,orchangingtheirco1.ourtowardsa1.ighterorwhiterShadeu

17、singchemica1.s,sometimesincombinationwiththeapp1.icationofauxi1.iarymeansaMcta4oraentryihangingtheco1.ourofnatura1.teethtowardsa1.ighterorwhitershadeisnot1.imitedtochangingNote2toentry:Auxi1.iar,meansforb1.eachingotherthantheapp1.icationofexterna1.energyarea1.soconceivab1.e.gURCE:ISO1942:2009,2.28,m

18、odifiedNote1toentryandNote2toentryhavebeenadded.professiona1.homeuseuseprescribedbyaprofessiona1.andforuseathomeundertherepeatedsupervisionof史dentisterosionprogressive1.ossofca1.cifiedtissuebychemica1.processesthatdonotinvo1.vebacteria1.action鼎吸(JE:anq猊糊,：融thetermhasbeenmodified,theadmittedtermhasbe

19、en4 C1.assification4.1 Genera1.Externa1.toothb1.eachingproductscanbec1.assifiedforeither：a) professiona1.app1.ication;orb) consumerapp1.ication.NOTEapp1.ication.Extcr11a1.toothb1.eachingproductscanbeuseda1.oneorinconjunctionwithauxi1.iarymeansof4.2 Productsforprofessiona1.app1.icationTheseproductsar

20、etoothb1.eachingproductsthatareintendedbythemanufacturertobeapp1.iedon1.y4y31.enta1.PrpiocfeJona1.sconurt6rapp1.fch1.iwingpro1.urts).Theseconsiimer(forareprofessiona1.b1.eachingproductsnon-professiona1.homemanufacturertobeapp1.iedbyNOTEConsumers-Suchexterna)b1.eachingproductscanbePreSCribedbyadenta1

21、professiona1.ordirect1.yavai1.ab1.eto5 Requirements5.1 Concentrationofactiveingredientsforb1.eachingTheconcentrationofactiveingredientsforb1.eaching(equiva1.enttohydrogenperoxide)de1.iveredbytHanfarcwteh)irtmctionsrfunwtfactutoraUtttuuftbpeaBgp6ductAnnexAorOtherequiva1.entmethodcanbeusedfortesting.

22、5.2 SurfaceIiiicrohardnessThereductionintheKnoophardness(KHN)orVickershardness(VHN)afterb1.eachingsha1.1.notexceedS%,则HfiU眇isionaccordancewith3.剑FiftftJsio曲明用hereq1.1.1.tnetfiWI1.dbyused.standardreference6Measurementsandtestmethods6.1 PreparationoftoothspecimensPrepareename1.anddentinespecimenstaken

23、fromaconsistent1.ocationonextractedhumanorbovinePsefjhertietJiaRWd1.1.beBbfMMjinenSuniMHra1.iZedaWJhaiontthatf1.eMitettHdrerinaiweianoe8Wtfrt(Stt3696startingatP400andsequentia1.1.ytoaminimumofP1200si1.iconcarbidepaperinaccordancewithISO6344-1.Thenpo1.ishthesurfaceusingas1.urryorpasteof0,3mmeanpartic

24、1.esizea1.uminium傥瞅三牖Stm0蝴/S1.(TO1.thicknesspr能f三UP丽眦tissueforthetestspecimen.Prevent6.2 Preparationandapp1.icationoftoothb1.eachingproductThedispensing,processingandapp1.icationofthetoothb1.eachingproductusedintests(seeAnnexC)6iaiH1111dbremi11qhHnUtyrMGSmKTiendfOnhiratiOnofmethodirikeh)He8pp1.jtio!

25、iHirinjUtva1.s,andfor24hafterthe1.astb1.eachapp1.icationpriortotesting,specimenssha1.1.bestoredat37inanartificia1.sa1.ivaso1.utionsimi1.artothatdescribedintheANSI/ADASpecificationNo.41.(66.3 SurfacemicrohardnessEva1.uateename1.surfacemicrohardnessbeforeandafterb1.eachingtreatmen1.%ejneEWN4VHNi阿帕&M即电

26、闲他构泠*fa()阳呼n.Preventdehydrationoftestspecimensduringthespecimenpreparationprocedure.7Packaging,markingandinformationtobesupp1.iedbythemanufacturer7.1 Genera1.Additiona1.informationmaybeinc1.udedatthediscretionofthemanufacturerorasrequiredbyISO22727.7.2 PackagingThecomponentsofthemateria1.sha1.1.besu

27、pp1.iedinproper1.ysea1.edcontainerswhichadequate1.y7r3tectMdnkingcMicfa11tdIhstructitoKadverse1.yuseaffecttheproductqua1.ity.Foreachpackage,thefo1.1.owingapp1.ies.a) Informationsha1.1.bec1.ear1.ymarkedontheoutermostpackageorcontainersappropriatetotheproduct,asindicatedinTab1.e1.b) 3闸V喇1。怆IOSH刈眺牛锵4Mt

28、ec帆北除of1.theproductandsha1.1.inc1.udetheinformationTab1.e1RequirementsformarkingandinstructionsforuseNo.InformationOutermostpackageContainerManufacturersinstructionsforuseM:mandatoryinformation:nonmundatorynfrmtonForsing1.eusecontainers,instructionsmaybe1.abe1.1.edonthesecondarypackaging.Theminimumi

29、nformationonsing1.eusecontainersrequiredare:manufacturername,tradename,1.otnumber,andexpirydate.AnnexA(informative)TestmethodforthemeasurementofhydrogenperoxideconcentrationA.1.Princip1.eThecontentOfhydrogenperoxide(HzOz)intoothb1.eachingproductsisdeterminedusingamodifiedAu3sTeMtconditionmethod.AjSo

30、nnProcedure(niffftidQhiosu1.fatetitrationmethod,USPp)Equiva1.entmethodscana1.sobeused.Useana1.ytica1.gradesu1.furicacid,potassiumiodide,ammoniummo1.ybdate,sodiumthiosu1.fate,starchandhydrogenperoxide.Conductatitrationca1.ibrationcurveusingaseriesoffresh1.ypreparedH2O2fcionsapproximate1.yconcetfens(i

31、1.hingindudeprtfsion%hest0,001JsSW3sPF?rttrationamd麻h涮6初仅tothetest,withrapidstirring,to400m1.disti1.1.edwaterthatcontains10m1.ofsu1.furicacid(25%),25m1.potassiumiodide(10%),and4dropsofammoniummo1.ybdateso1.ution(5%).Usestarchastheindicator,andperformthetitrationusing0,1N(norma1.ity)sodiumthiosu1.fat

32、e.DeterminetheH2O2contentusingthetitrationca1.ibrationcurve.搬将H图汨圾NaSS钿掘带用华幽H8删航斓A：ofaca1.ibrationcurveisnotC=(1,70118Vm)y,0.1100(A.1)whereCvisthemassConcentiationofH2O2,expressedasapercentage；misthetitreof0.1Nsodiumthiosu1.fate,expressedinmi1.1.i1.itres；Yisthemassofthetestproductdispensed,expressed

33、inmi1.1.igrams；istheaccurateconcentrationofsodiumthiosu1.fate,expressedinmo1./1.itre.Repeatthemeasurementfivetimesn=5)andca1.cu1.atethemeanHzOzconcentration.部JTEmethOd碗照时刖砧IngganunH第iwnindicativm阴ig蚓CeOfSodiIImhypoch1.orite,whichisre1.evantwhenEXAMP1.EAnexamp1.eofproceduresofsamp1.emeasurementbyusin

34、gtheImagcJsoftwareisasfo1.1.ows:a) C1.ickTi1.e,andchooseOpen.*fromthescro1.1.ing1.ist.b) Se1.ectthefi1.etobeusedthenc1.ickOpento1.oadtheimage.C)Thefirsttimeanimageisopenedaftersettingtheca1.ibration,adia1.ogueboxwi1.1.appearaskingabouttheg1.oba1.ca1.ibration.Inthiscase：d) UnchecktheDisab1.eG1.oba1.C

35、a1.ibration,.e) CheckDisab1.eTheseMessages*andc1.ick,0K,toretaintheca1.ibration.0C1.ickImage,andmovethersortoTransformandse1.ectRotate.*torotatetheimagetovertica1.suchthattheerosionzoneisvertica1.asshowninFigureB.9.g) frtwk而g1.e(degrees)*ofthedia1.ogueboxtopositiontheimage(i.e.90)withouttouchingtheh

36、) Adjustthedegreesneededtomaketheimagevertica1.thenc1.ick0K.1) q4*C(Xf1.hg1.ebJftEWvbfninthesecond1.ineofcommandbartodrawarectang1.eonthej)C1.ickAna1.ysethenchooseT1.otProfi1.etogeneratethegraphofthegraysca1.eofthese1.ectedarea.k)也演名&咽曲即加腋确Wth1.三i左蜕1纳晚树祖网i网WM小闻给ecord嘛d限版Va1.UCerosion.AnnexCTestmetho

37、dfor1.aboratoryassessmentoftoothb1.eachingefficacyC.1.Princip1.eC.28Materia1.s,equipmentandeva1.uationconditionC.2.1C.2.2C.2.3forvisua1.assessmentoftoothshade(seeC.3.3.2).C.2.4C.3ProceduresC.3.1SpecimenpreparationShadeASguideVitapandcpendingOnshadeexpectedotherwiseefficacy)wthofV1.TzMabia1.B1.eached

38、guiderestorations.group,dependingtoothspecimensFandom1.yco1.ourgroups,expectedspecimensperb1.eachingspecimensperC.3.2B1.eachingtreatmentprocedures.TreattheSPCdmenSindisti1.1.edwater(C.2.2)undertheconditionsoftest.arcVitapanC1.assica1.shadeguidccxamp1.csVITB1.cachcdguidc3D-Mastercommercia1.1.y.Th1.Si

39、nformationIsGennany)19(informative)Dataareobtainedontoothb1.eachingefficacyofaproductusinga1.aboratorymethod:seeReferences5,6.and9.Extractedhumanteethorbovineincisors.PrepareteethinaccordancewithC.3.1Usingappropriateinfectioncontro1.procedures.Disti1.1.edwater,inaccordancewithISO3696,Grade2.Shadegui

40、de.Useatoothshadeguideunderco1.ourcorrected1.ighting(e.g.6500K)inaccordancewithISO11664-2E1.ectronicpreparation.Useaninstrumentsuchasaco1.orimeter,spectrophotometerordigita1.imagingdevice.Se1.ectextractedhumanorbovine,cariesanderosionfree,teethofpropertoothco1.our(e.g.A2orof3)C1.assica1.theguide,b1.

41、eaching2M2or3M2no1.esionsor3D-MasterStoretheteethinaneutra1.izedso1.utionthatdisinfectsbutdoesnota1.terthephysica1.propertiesofthespecimens.C1.eanthetoothsurfaceofanystainsandca1.cu1.us.Assignacodenumbertoeachspecimenandassigntheonthebase1.inetoothintoandwith6efficacyofthegroupto1Oproduct.Preventdeh

42、ydrationoftestspecimensduringthespecimenpreparationprocedure.Fo1.1.owthemanufacturersinstructionsforuse.Preventdehydrationoftestspecimensduringa1.1.3)suchshadeguidesandarcandofsuitab1.eproductsavai1.ab1.e(VitaZahnfabrik,BadSackingen,givenfortheconvenienceofusersofthisdocumentanddoesnotconstituteanendorsementbyISOoftheseproducts.C.3.3B1.eachingefficacyassessmentC.3.3.1Genera1.Theefficacyofab1.eachingproductshou1.dbeestab1.ishedbythedeterminationofac1.inica1.1.yre1.evantBMi