EN ISO 4823 2025.docx

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1、ENISO4823June2025Zahnheilkunde-ElastomereAbform-undBissregistriermaterialien(ISO4823:2025)EUROPEANSTANDARDNORMEEUROPEENNEEuropaischenormICS11.060.10SupersedesENISO4823:2021EnglishVersionDentistry-ElastomericimpressionandbiteregistrationmaterialsISO4823:2025Medecinebucco-dentaire-Produitspourempreint

2、esetmateriauxpourenregistrementdesrapportsintermaxillairesabased,elastomeres(ISO4823:2025)ThisEuropeanStandardwasapprovedbyCENon21June2025.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalte

3、ration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCEN

4、memberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembo

5、urg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:RuedelaScience23,B-1040Bru

6、ssels2025CENAllrightsofexploitationinanyformandbyanymeansreservedRef.No.ENISO4823:2025EworldwideforCENnationalMembers.EuropeanforewordThisdocument(ENISO4823:2025)hasbeenpreparedbyTechnicalCommitteeISO/TC106DentistryincollaborationwithTechnicalCommitteeCEN/TC55DentistrythesecretariatofwhichisheldbyDI

7、N.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyDecember2025,andcon11ictingnationalstandardsshallbewithdrawnatthelatestbyDecember2025.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpa

8、tentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO4823:2021.Anyfeedbackandquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite.AccordingtotheCEN-CENELECIn

9、ternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Pol

10、and,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandtheUnitedKingdom.EndorsementnoticeThetextofISO4823:2025hasbeenapprovedbyCENasENISO4823:2025withoutanymodification.ContentsPageForewordv1 Scope12 Normativereferences13 Termsanddefinitions14 Clas

11、sification25 Requirements25.1 Componentcolours(notapplicablefortransparentmaterials)25.2 Mixingtime(hand-spatulatedorhand-kneadedmixes)35.3 Consistency35.4 Workingtime35.5 Detailreproduction35.6 Lineardimensionalchange35.7 Compatibilitywithgypsum35.8 Elasticrecovery35.9 Strainincompression35.10 Mini

12、mumtimeintheoralcavityforbiteregistrationmaterials35.11 Compressionsetofbiteregistrationmaterials35.12 Hardnessofbiteregistrationmaterials36 Pre-testplanningapproaches46.1 General46.2 Sampling46.3 Pre-testproductexaminations46.3.1 General46.3.2 Examinationsforconformitywithlabellingrequirements46.3.

13、3 Examinationsforeffectivenessofthepackaging.56.3.4 Examinationsforcompliancewithrequirementsforinstructionsforuse56.4 Essentialpre-testpreparatorypractices56.4.1 Laboratoryconditions56.4.2 Apparatusfunctionverificationsteps56.4.3 Volumeofmaterialstobemixedforeachspecimen56.4.4 Proportioning,mixinga

14、ndhandlingofhand-mixedmaterialstobetested66.4.5 Timingforthespecimenpreparationandtestprocedures66.4.6 Simulatedoraltime/temperaturetreatmentofspecimensformedincompletelyclosedmouldassemblies66.5 Pass/faildeterminations66.6 Expressionoftestresults67 Testmethods67.1 Mixingtime67.1.1 Apparatus67.1.2 S

15、pecimenpreparationandtestprocedure(fivespecimens)67.1.3 Pass/faildeterminationandexpressionofresults67.2 Consistency77.2.1 Apparatusandmaterials77.2.2 Advancepreparationsteps77.2.3 Specimenpreparationandtestprocedure(fivespecimens)77.2.4 Pass/faildeterminationandexpressionofresults87.3 Workingtime87

16、3.1 Apparatus87.3.2 Workingtimetest97.4 Detailreproduction107.4.1 Apparatusandmaterials107.4.2 Specimenpreparation107.4.3 Testprocedure117.4.4 Pass/faildeterminationandexpressionofresults117.5 Lineardimensionalchange117.5.1 Apparatusandmaterials117.5.2 Testblockline-lengthmeasurementprocedure117.5.

17、3 Specimenpreparation127.5.4 Testspecimenmeasurement127.6 Compatibilitywithgypsum137.6.1 Apparatusandmaterials137.6.2 Specimenpreparation147.6.3 Testprocedure147.6.4 Pass/faildeterminationandexpressionofresults147.7 Elasticrecovery147.7.1 Apparatusandmaterials147.7.2 Specimenpreparation157.7.3 Testp

18、rocedure157.7.4 Calculationofresults167.7.5 Pass/faildeterminationandexpressionofresults.167.8 Strainincompression167.8.1 Apparatus167.8.2 Specimenpreparation167.8.3 Testprocedure167.8.4 Calculationofresults177.8.5 Pass/faildeterminationandexpressionofresults177.9 Minimumtimeintheoralcavityandcompre

19、ssionsetforbiteregistrationmaterials177.9.1 Apparatus177.9.2 Specimenpreparation177.9.3 Testprocedure177.9.4 Evaluation177.9.5 Pass/faildeterminationandexpressionofresults187.10 Hardnessofbiteregistrationmaterials187.10.1 Apparatus187.10.2 Specimenpreparation187.10.3 Testprocedure187.10.4 Evaluation

20、187.10.5 Pass/faildeterminationandexpressionofresults188 Requirementsforlabellingandinstructionssuppliedbythemanufacturer198.1 Labellingrequirements198.2 Instructionsforuse198.2.1 General198.2.2 Forallmaterialscoveredbythisdocument208.2.3 Forallimpressionmaterials208.2.4 Additionalinstructions20Anne

21、x A (normative)Figures22Annex B (normative)Standardizedhandmixingmethods30Bibliography33ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittee

22、s.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallm

23、attersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.Thisdocumentwasdraftedinaccordancewiththeeditor

24、ialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdoc

25、ument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.However,implementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.An

26、ytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISOsadherencetotheWorldTradeOrganization(WTo)princip

27、lesintheTechnicalBarrierstoTrade(TBT),seewww.iso.org/iso/foreword.htmLThisdocumentwaspreparedbyTechnicalCommitteeISO/ISO/TC106,Dentistry,SubcommitteeSC2,Prosthodonticmaterials,incollaborationwiththeEuropeanCommitteeforStandardization(CEN)TechnicalCommitteeCEN/TC55,Dentistry,inaccordancewiththeAgreem

28、entontechnicalcooperationbetweenISOandCEN(ViennaAgreement).Thissixtheditioncancelsandreplacesthefifthedition(ISO4823:2021),whichhasbeentechnicallyrevised.Themainchangesareasfollows:一packagingandinstructionsforuserequirementshavebeenupdated;editorialcorrectionshavebeenmade.Anyfeedbackorquestionsonthi

29、sdocumentshouldbedirectedtotheusersnationalstandardsbody.AcompletelistingofthesebodiescanbefoundatWWW.iso.org/membnrs.htmLDentistryElastomericimpressionandbiteregistrationmaterials1 ScopeThisdocumentspecifiestherequirementsandtheirtestmethodsforelastomericimpressionandbiteregistrationmaterials.2 Nor

30、mativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO48-4,Rubber,vulcanizedort

31、hermoplasticDeterminationofhardnessPart4:Indentationhardnessbydurometermethod(Shorehardness)ISO1942,DentistryVocabularyISO6873,DentistryGypsumproducts3 TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO1942andthefollowingapply.ISOandIECmaintainterminologydatabasesforuse

32、instandardizationatthefollowingaddresses: ISOOnlinebrowsingplatform:availableathttps:WWW.iso.org/obp IECElectropedia:availableathttps:WWW.electropedia.org/3.1consistencydegreeoffirmnesswithwhichparticlesofamaterial,preparedforuse,coheresoastoallowthematerialtoflow,orresistflow3.2elasticrecoveryabili

33、tyofanelastomertoreturntoitsoriginalshapewhenacompressionloadisremoved3.3extrusionmixingmethodbywhichtwoormorematerialcomponentsareextrudedsimultaneouslyfromtheirseparateprimarycontainersthroughamixingnozzlefromwhichthematerialcomponentsemergeasahomogeneousmixture3.4handmixingmethodofmixingthecompon

34、entsofamaterialbymeansofmanualkneadingorSpatulation3.5hardnessresistancetoindentationNote1toentry:Inthisdocument,thistermreferstoshorehardnessaccordingtoISO48-4,TypeA.ISO2025-AllrightsreservedSOURCE:ISO1382:2020,3.247,modifiedNote1toentrywasadded.3.6minimumtimeintheoralcavityminimumtimenecessaryfort

35、hematerialtoremainintheoralcavitytopreventsignificantdeformation3.7mixingtimetime,measuredfromfirstcontactbetweendifferentcomponentsofamaterialbeingmixed,untilahomogeneousmixtureofthecomponentsisachievedNote1toentry:Thetimeoffirstcontactbetweenextrusion-mixedmaterialcomponentsisdefinedasthetimewhent

36、hematerialcomponentsenterthemixingnozzle.3.8outerpackagewrappingorcartonusedtocoveroneormoreprimarycontainersinpreparationforretailmarketingNote1toentry:Legislationorspecificstandardscanapply.3.9primarypackagingcontainerdesignedtocomeintodirectcontactwiththeproductSOURCE:ISO21067-1:2016,2.2.3,modifi

37、edTerm“packagingreplacedwith“container“inthedefinition.3.10strainincompressionflexibility/stiffnesspropertyrangesofthematerialsthatdetermineswhetherthesetmaterials,whenformedasimpressions,canberemovedfromthemouthwithoutinjurytotheimpressedoraltissuesandhaveadequatestiffnessinthemoreHexibleportionsof

38、impressionstoresistdeformationwhenmodelformingproductsarepouredagainstthem3.11workingtimeperiodoftimebeginningwiththecommencementofmixingandendingbeforethematerialbeingmixedhasbeguntoexhibitelasticpropertiesthatpreventsthematerialfrombeingmanipulatedasrequiredtoformanimpressionoramouldhavingthedesir

39、edsurfacedetailanddimensionalcharacteristics4ClassificationMaterialscoveredbythisdocumentareclassifiedaccordingtothefollowingconsistencies,whicharedeterminedimmediatelyaftermixingiscompleteaccordingtothemanufacturersinstructions(see8.2):Type0:puttyconsistency;一Type1:heazy-bodiedconsistency;一Type2:me

40、dium-bodiedconsistency; Type3:light-bodiedconsistency; TypeB:biteregistrationmaterials.5 Requirements5.1 Componentcolours(notapplicablefortransparentmaterials)Differentcomponentsintendedforuseinthesamemixtureshallbesuppliedincontrastingcolourstoprovideameansofdeterminingwhenthecomponentshavebeenthor

41、oughlymixed.5.2 Mixingtime(hand-spatulatedorhand-kneadedmixes)Whenthematerialcomponentsarecombinedaccordingtothemanufacturer/sinstructionsandtheresultsofthemixingareevaluatedaccordingto7.1,theaveragetimerequiredtoachieveahomogeneousmixture(essentiallystreak-free)shallnotexceedthetimestatedbythemanuf

42、acturer.5.3 ConsistencyWhentestedaccordingto7.2,thetestdiscdiametershallbeintherangegiveninTable1fortheconsistencyassignedtothematerialbythemanufacturer.5.4 WorkingtimeWhentestedaccordingto7.3,theworkingtimeshallnotbelessthanthatstatedinthemanufacturersinstructions.5.5 DetailreproductionWhentestedac

43、cordingto7.4,thelinewidthreproducedshallnotexceedtheappropriatevaluegiveninTable15.6 LineardimensionalchangeWhentestedaccordingto7.5,thelineardimensionalchangeshallnotexceedtheappropriatevaluegiveninTable1.5.7 CompatibilitywithgypsumTheimpressionmaterialshallleaveasmoothsurfaceonthegypsummodelmateri

44、al.Itshallalsoseparatecleanlyfromthegypsummodelmaterialpouredagainstit.Whentestedaccordingto7.6,thelinewidthreproducedshallnotexceedtheappropriatevaluegiveninTableL5.8 ElasticrecoveryWhentestedaccordingto7.7,theelasticrecoveryshallbegreaterthanorequaltothevaluegiveninTable1.5.9 StrainincompressionWh

45、entestedaccordingto7.8,thestrainincompressionshallbeintheappropriaterangegiveninTableL5.10 MinimumtimeintheoralcavityforbiteregistrationmaterialsWhentestedaccordingto719,theminimumtimeintheoralcavityshallbesmallerthanorequaltothevaluegivenbythemanufacturerintheinstructionsforuse.5.11 Compressionseto

46、fbiteregistrationmaterialsWhentestedaccordingto7.9,thecompressionsetafterloadremovalshallbelessorequaltothevaluegiveninTabIe1.5.12 HardnessofbiteregistrationmaterialsWhentestedaccordingto7.10,thehardnessofthematerialshallbegreaterthanorequaltothevaluegiveninTabIeLTable1Characteristicandphysicalprope

47、rtyrequirementsTypeTestsubclausenumberanddescription7.27.47.57.67.77.87.97.10Consistency(testdiscdiameter)mmDetailreproduction(linewidthreproduced)amLineardimensionalchange%max.Compatibilitywithgypsum(linewidthreproduced)amElasticrecovery%Strainincompression%CompressionsetmmHardnessShoreAmin.max.min.min.Imax.max.min.03575L57596,50,8I20,01355055096,50,8I20,02314120L55096,52,0I20,0336201,55096,52,0I20,0B1,5-1-