ISO 28399-2021.docx

INTERNATIONA1.STANDARDISO28399editionThird202103DentistryExterna1.toothb1.eachingproductsMedecinebuccodentaireProduitsdc1.aircissementdentaireparvoteexterneOISO2021COPYRIGHTPROTECTEDDOCUMENT©ISO2021岫rkdea/山thUcdOthcnviscjft<c三orrtmcehDVBiwixuioiti08phnn11UatiocBhr<1.>hotoc<>p)Mng,ptbcatonpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanherequestedfromeitherISOattheaddressbe1.oworIS<smemberbodyinthecountryoftherequester.%,tft晒Iandonnet8CH-1214*crnicr,GenevaPhone：M1.22749O1.11Pub1.ishedinSwitzerhndContentsPageForewordivIntroductionv2Scope13Normativereferences14Termsanddefinitions1C1.assification24.1Genera)24.2Productsforprofessiona1.app1.ication25Requirements35.1Concentiationofactiveingredientsforb1.eaching35.2Surfacemicrohardness36Measurementsandtestmethods36.1Preparationoftoothspecimens36.2Preparationandapp1.icationoftoothb1.eachingproduct37Packaging,markingandinformationtobesupp1.iedbythemanufacturer371Gener3137.2Packaging473MarkingandinwtructinnwforI1.qe4AnnexA(informative)Testmethodforthemeasurementofhydrogenperoxideconcentration5AnnexB(informative)1.ightmicroscopymethodformeasuringerosionofename1.anddentinecausedbyexterna1.toothb1.eachingproducts6AnnexC(informative)Testmethodfor1.aboratoryassessmentoftoothb1.eachingefficacy19Bib1.iography22ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsthiiugh(ISOm(iumbif1.4>ni)rhuceiwHPfff1.PbbGgbOdyhIrf1.nmwbtandrikfowhtdIyuHmed¾mitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO,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.esoftheISO/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.opmerUW4ie÷wmwVw1.1.beintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(seewww.iso.org/pa1.ents).Anytradeusedinthisconstitutenameendorsement.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vv¼w.iso.orgiso/forewod.htmI.辎则胸asJ8的杵曲邨抑ee1.ffittee5R硒1.izationSUiW而“他Gnica1.CommitteeCEN/TC55,Dentistry,inaccordancewiththeAgreementontechnica1.cooperationbetweenISOandCEN(ViennaAgreement).版乐曲B袍川9H件的kH94dghfrW)MeditftVfi(¥99:2020),whichhasbeeneditoria1.1.ynTEM"hasbeenremovedfrom"TEMgrid"throughoutthisthirdedition;B.10.2.6EXMP1.Ehasbeenrewritten;mB.9A)"hasbeenrep1.acedwith"B.9”;一,Sce4we-9Bmhasbeenremoved;*1.nFigureB.9C,theva1.ueis51,9163(i.e.51,9VmrhaSbeenremovedandFigureB.9,k),"numberof"hasbeenrep1.acedwith"widthin"InC.3.3.3,',EM"hasbeenaddedinthespacebetweentwocommas.Anyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheuser,snationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.4so.erg/mefnbeFSrhtm1.IntroductionExterna1.toothb1.eachingp11)ductsareusedindentistryforchangingtheco1.ourofnatura1.teethtowardsa1.ighterorwhitershade.Theyareapp1.iedintheora1.cavitydirect1.yontheoutersurfacesofteeth.Specificqua1.itativeandquantitativerequirementsforfreedomfrombio1.ogica1.hazardarenotinc1.udedinthisdocumentReferenceshou1.dbemadetoISO10993-1andISO7405whenassessingpossib1.ebio1.ogica1.ortoxico1.ogica1.hazards.Dentistry-Externa1.toothb1.eachingproducts1ScopeTheseb1.eachingproducts)orConSUmerapp1.icationcavity,(PrOfeSSiona1.non-professiona1.hf>me(in-officeThisdocumentisnotapp1.icab1.etotoothb1.eachingproducts：intendedrestorativeapproaches,suchasveneersteethcrownsmechanica1.methods(e.g.stainremova1.)thatareusedinconjunctionwiththeb1.eachingproducts.NOTECoUntryregU1.atOryConCentratiOnOfab1.eachingagentforprofessiona1.ornon-professiona1.useissubjectto2Normativereferencesconstitutesrequirenents1.atesteditiondocument.referencedreferences,(inc1.udingamendments)app1.ies.app1.ies.ISO1942,DentistryVocabu1.aryISO6344-1,CoatedabrasivesGrainsizeana1.ysisPart1：GrainsizedistributiontestISO8601-2,DateandtimeRepresentationsforinformationinterchangePart2:ExtensionsISO11664-2,Co1.orimetryPart2:C1.EstandardH1.uminantsMateria1.s3TermsanddefinitionsISOandIECmaintaintermino1.ogica1.databasesforUSeinStandardiZatiOnatthefo1.1.owingaddresses:1Thisdocumentspecifiestherequirementsandtestmethodsforexterna1.toothb1.eachingproducts.toothproductsareinten