EN ISO 4823 2025.docx

ENISO4823June2025Zahnheilkunde-ElastomereAbform-undBissregistriermaterialien(ISO4823:2025)EUROPEANSTANDARDNORMEEUROPEENNEEuropaischenormICS11.060.10SupersedesENISO4823:2021EnglishVersionDentistry-ElastomericimpressionandbiteregistrationmaterialsISO4823:2025Medecinebucco-dentaire-Produitspourempreintesetmateriauxpourenregistrementdesrapportsintermaxillairesabased,elastomeres(ISO4823:2025)ThisEuropeanStandardwasapprovedbyCENon21June2025.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:RuedelaScience23,B-1040Brussels©2025CENAllrightsofexploitationinanyformandbyanymeansreservedRef.No.ENISO4823:2025EworldwideforCENnationalMembers.EuropeanforewordThisdocument(ENISO4823:2025)hasbeenpreparedbyTechnicalCommitteeISO/TC106"Dentistry"incollaborationwithTechnicalCommitteeCEN/TC55"Dentistry"thesecretariatofwhichisheldbyDIN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyDecember2025,andcon11ictingnationalstandardsshallbewithdrawnatthelatestbyDecember2025.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO4823:2021.Anyfeedbackandquestionsonthisdocumentshouldbedirectedtotheusers'nationalstandardsbody/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandtheUnitedKingdom.EndorsementnoticeThetextofISO4823:2025hasbeenapprovedbyCENasENISO4823:2025withoutanymodification.ContentsPageForewordv1 Scope12 Normativereferences13 Termsanddefinitions14 Classification25 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 Minimumtimeintheoralcavityforbiteregistrationmaterials35.11 Compressionsetofbiteregistrationmaterials35.12 Hardnessofbiteregistrationmaterials36 Pre-testplanningapproaches46.1 General46.2 Sampling46.3 Pre-testproductexaminations46.3.1 General46.3.2 Examinationsforconformitywithlabellingrequirements46.3.3 Examinationsforeffectivenessofthepackaging.56.3.4 Examinationsforcompliancewithrequirementsforinstructionsforuse56.4 Essentialpre-testpreparatorypractices56.4.1 Laboratoryconditions56.4.2 Apparatusfunctionverificationsteps56.4.3 Volumeofmaterialstobemixedforeachspecimen56.4.4 Proportioning,mixingandhandlingofhand-mixedmaterialstobetested66.4.5 Timingforthespecimenpreparationandtestprocedures66.4.6 Simulatedoraltime/temperaturetreatmentofspecimensformedincompletelyclosedmouldassemblies66.5 Pass/faildeterminations66.6 Expressionoftestresults67 Testmethods67.1 Mixingtime67.1.1 Apparatus67.1.2 Specimenpreparationandtestprocedure(fivespecimens)67.1.3 Pass/faildeterminationandexpressionofresults67.2 Consistency77.2.1 Apparatusandmaterials77.2.2 Advancepreparationsteps77.2.3 Specimenpreparationandtestprocedure(fivespecimens)77.2.4 Pass/faildeterminationandexpressionofresults87.3 Workingtime87.3.1 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