EN ISO 14356 2024.docx

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1、ENISO14356October2024EuropeanstandardNormeeuropeenneEuropaischenormICS11.060.10SupersedesENISO14356:2003EnglishVersionDentistry-DuplicatingmaterialISO14356:2024Medecinebucco-dentaire-ProduitspourduplicationZahnheilkunde-Dublierwerkstoffe(ISO14356:2024)(ISO14356:2024)ThisEuropeanStandardwasapprovedby

2、CENon13October2024.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENE

3、LECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersareth

4、enationalstandardsbodiesofAustria,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,Swit

5、zerland,TiirkiyeandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:RuedelaScience23,B-1040Brussels2024CENAllrightsofexploitationinanyformandbyanymeansreservedRef.No.ENISO14356:2024EworldwideforCENnationalMembers.C

6、ontentsPageEuropeanforeword3EuropeanforewordThisdocument(ENISO14356:2024)hasbeenpreparedbyTechnicalCommitteeISO/TC106DentistryincollaborationwithTechnicalCommitteeCEN/TC55Dentistry“thesecretariatofwhichisheldbyDIN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanid

7、enticaltextorbyendorsement,atthelatestbyApril2025,andconflictingnationalstandardsshallbewithdrawnatthelatestbyApril2025.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Thisdocumentsupe

8、rsedesENISO14356:2003.Anyfeedbackandquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplement

9、thisEuropeanStandard: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,Switzerla

10、nd,TiirkiyeandtheUnitedKingdom.EndorsementnoticeThetextofISO14356:2024hasbeenapprovedbyCENasENISO14356:2024withoutanymodification.Page34.4.4.4.4.44.4.44555LQLQ.5LQ.5.6.6.6.7.7.77.7.8.9.9.9999001122231444-11111111111Contents1Scope2Normativereferences3 Termsanddefinitions4 Classificationbytypes5 Mater

11、ialcharacteristicsandpropertiesRequirements5.1 General5.2 Meltingtemperature-Type1materials5.3 PouringtemperatureType1materials5.4 ComponentcoloursType2materials5.5 Detailreproduction5.6 Compatibilitywithrefractoryinvestmentand,ifapplicable,gypsum5.7 Elasticrecovery5.8 Tearstrength5.9 Resistancetofu

12、ngalgrowthType1materialsonly6 Sampling7 TestmethodsGeneral7.1 Laboratoryconditions7.2 Verificationofapparatusfunction7.3 Specimenpreparationandtesting7.3.1 General7.3.2 PreparationofType1materials7.3.3 PreparationofType2materials7.4 Pass/faildeterminations7.5 Expressionoftestresults8 Specificspecime

13、npreparationandtestprocedures8.1 MeltingtemperaturetestType1materialsonly8.2 Detailreproductiontest8.2.1 Apparatusandmaterials8.2.2 Specimenpreparation(threespecimens)8.2.3 Testprocedure8.2.4 Pass/faildeterminationandexpressionofresults8.3 Testforcompatibilitywithrefractoryinvestmentand,ifapplicable

14、gypsum8.3.1 Apparatusandmaterials8.3.2 Specimenpreparation8.3.3 Testprocedure8.3.4 Pass/faildeterminationandexpressionofresults8.4 Elasticrecoverytest8.4.1 ApparatusType1materials8.4.2 Apparatus-Type2materials8.4.3 Apparatus-Type1andType2materials8.4.4 SpecimenpreparationType1materials(fivespecimen

15、s)8.4.5 SpecimenpreparationType2materials(fivespecimens)8.4.6 TestprocedureType1andType2materials8.4.7 Calculationofresults8.4.8 Pass/faildeterminationsandexpressionofresults8.5.1 Apparatusandmaterials8.5.2 Specimenpreparation(fivespecimens)8.5.3 Testprocedure8.5.4 Calculationofresults8.5.5 Pass/fai

16、ldeterminationandexpressionofresults8.6FungalgrowthresistancetestType1agarmaterialsonly148.6.1 Apparatusandmaterials148.6.2 Specimenpreparation(1testspecimenand1controlspecimen)148.6.3 Testprocedure148.6.4 Pass/faildetermination148.6.5 Expressionofresults159 Requirementsforpackaging1510 Requirements

17、forlabelling1511 InstructionsforuseRequiredinformation15AnnexA(informative)Optionalprocedureforteartest26Bibliography30ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarried

18、outthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmentabinliaisonwithIS0,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectro

19、technicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.Thisdocumentwasd

20、raftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.As

21、ofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.However,implementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.orgpatents.ISOshallnotbeheldresponsibleforidentify

22、inganyorallsuchpatentrights.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISOsadherencetotheWorl

23、dTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT),Seewwwtso.org/iso/foreword.htmLThisdocumentwaspreparedbyTechnicalCommitteeISO/TC106,Dentistry,SubcommitteeSC2fProsthodonticmaterials,incollaborationwiththeEuropeanCommitteeforStandardization(CEN)TechnicalCommitteeCEN/TC55,Dentistry,

24、inaccordancewiththeAgreementontechnicalcooperationbetweenISOandCEN(ViennaAgreement).Thissecondeditioncancelsandreplacesthefirstedition(ISO14356:2003),whichhasbeentechnicallyrevised.Themainchangesareasfollows:一figureshavebeenupdatedtobeconsistentwithotherimpressionmaterialrelatedstandards;一terminolog

25、y,referencesanddocumentformathavebeenupdated.Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody.AcompletelistingofthesebodiescanbefoundatWWW.iso.org/membnrs.htmLDentistryDuplicatingmaterial1 ScopeThisdocumentspecifiestherequirementsandtestsfortheduplicatingmaterialsu

26、sedindentistrywhichareprimarilyintendedforformingflexiblemouldsneededtoproducepositiverefractoryinvestmentcopiesofproperlyblocked-outmastermodels.2 NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferen

27、ces,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO1942,Dentistry一VocabularyISO6873,Dentistry-GypsumproductsISO15912,DentistryRefractoryinvestmentanddiematerialASTMD624-00,Standardtestmethodfortearstrengthofconventionalvulcan

28、izedrubberandthermoplasticelastomers3 TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO1942andthefollowingapply.ISOandIECmaintainterminologydatabasesforuseinstandardizationatthefollowingaddresses:一ISOOnlinebrowsingplatform:availableathttps:WWW.iso.org/obp一IECElectroped

29、ia:availableathttps:WWW.electropedia.org/3.1doubleboilercontainersysteminwhichtheuppercontainerfitsintothelowercontainersuchthatboilingwaterinthelowercontainerheatsthecontentsofthelid-covereduppercontainer3.2non-reversibleduplicatingmaterialmaterialwhichconvertsfromapourableconsistencytoagelorrubber

30、likestateandwhichthereaftercannotbereturnedtothepourableconsistencyforrepeateduse3.3effectivesettingtimetimemeasuredfromthecommencementofmixingcomponentsofamaterialtogether,orotherwiseactivatingthechemistryinvolved,tothetimeatwhichtheactivatedmaterialhasdevelopedtheproperties(elasticity,hardness,et

31、c.)thatwillpermitittobeusedwithoptimaleffectivenessinasubsequentsteporforitsintendedpurposeNote1toentry:Thisappliestomaterialssettingatornearoralorroomtemperature.3.4functionallifenumberoftimesamaterialcanberecycledforuse,ifhandledandusedaccordingtothemanufacturersinstructions,withoutlossoftheproper

32、tiesrequiredtoensurethatthematerialisfitforthepurposeintendedNote1toentry:Thisappliestoreversibleduplicatingmaterial.3.5gelationtransitionofamaterialfromarelativelyfluidconsistencytoagelstateinwhichthematerialhasdevelopedtheelasticpropertiesneededforitsintendedpurposeNote1toentry:Thisappliestoagardu

33、plicatingmaterial.3.6immediatecontainerpackagingcomponentthathasinternalsurfacesindirectcontactwiththematerialcontainedNote1toentry:Animmediatecontainercanbeanunlabelledcontainerprotectedbymoredurableouterpackaging,suchasacan,cartonordrum.Ifstrongenoughtoprotectitscontentswithoutouterpackaging,animm

34、ediatecontainercanserveasaprimarycontaineronwhichlabellingmayberequired.3.7initialsettingtimetimemeasuredfromthecommencementofmixingcomponentsofamaterialorotherwiseactivatingthechemistryinvolvedandendingatatimewhenresultsofaprescribedtest,conductedataspecifiedtemperature,showthatthemixturehasbegunto

35、set,thusindicatingthattheeffectivesettingtimeisreachedatsomepredictabletimethereafterNote1toentry:Initialsettingtimesstatedinthemanufacturersinstructionsareusefultotestoperators,users,andstandardsdevelopersbecause:一theycanoftenbeusedfordeterminingwhetheraproductisofaqualitysuitablefortestingoruse.Fo

36、rexample,iftheinitialsettingtimefoundbythetestoperatororusercorrespondscloselytothatstatedintheinstructions,itcanusuallybeassumedthattheproductissuitablefortestingoruse.一theycanbehelpfulinthedevelopmentofstandardsforcertainmaterialsifthereisaneedforastandardtoidentifyareferencepointintimethatcanbeus

37、edasabasisforspecifyingwhencertainsubsequentproceduresshouldbegin.SOURCE:ISO1942:2020,3.3.1.31,modified-Notetoentryadded.3.8investmentpowderedrefractory(3.13)containingabinder,tobemixedwithaspecifiedliquidtoformaslurrythatcanbepouredintoamouldmadeofduplicatingmaterialwhereitisallowedtohardentoformah

38、eat-resistantpositivecopyofamastermodel,orwhichcanbepouredaroundpatternstoformaheat-resistantmouldusedforformingceramicormetalobjectsNote1toentry:Thisappliestoacastingmaterial.3.9meltchangeamaterial,byheating,fromagelstatetoapourablefluidstateNote1toentry:Thisappliestoagarhydrocolloid.3.10outerpacka

39、gewrappingorcarton,usedtocoveroneormoreimmediatecontainers(3.6)orprimarycontainers(3.12)inpreparationforretailmarketingNote1toentry:Legislationorspecificstandardscanapply.SOURCE:ISO4823:2021,3.83.11pouringtemperaturetemperatureofthematerialdesignatedinthemanufacturersinstructionsforpouringthemateria

40、laroundanobjecttobeduplicatedNote1toentry:Thisappliestoduplicatingmaterial.3.12primarycontainerpackagingcomponentforretailmarketingwhichcanbecoveredbyanouterpackage(3.10)EXAMPLEBottle,carton,drum,jar,tube,etc.Note1toentry:Aprimarypackagecanberequiredtobearspecificlabellinginformationbylegislationors

41、pecificstandard.Note2toentry:Aprimarycontainermayalsobeanimmediatecontainer(3.6),andviceversa.3.13refractorymaterialthatretainsitseffectiveshapeandcompositionwhenheatedtothemaximumtemperaturerequiredforitsuse3.14slurrymixture,consistingofapowderandwater,orapowderandanotherliquid,thathasaconsistencyt

42、hatallowsittobepouredaroundpatternsorintomoulds,ortobeotherwiseapplied,andthenbeallowedorcausedtohardensoastoformadesiredshapeNote1toentry:Thisappliestoceramic,gypsumorinvestmentmaterials.3.15storageholdingofamaterialinanimmediatecontainer(3.6)inaprotectedenvironmentbeforethecontainerisopenedforthef

43、irstuse,andbetweensubsequentopeningsofthecontainer3.16store,verb(agarhydrocolloid)toholdamaterialatthetemperaturespecifiedinthemanufacturersinstructionstokeepitatpouringconsistencyNote1toentry:Thisappliestoagarhydrocolloid.4 ClassificationbytypesTherearetwotypesofduplicatingmaterial:一Type1:reversibl

44、eduplicatingmaterials;一Type2:non-reversibleduplicatingmaterials.5 MaterialcharacteristicsandpropertiesRequirements5.1 GeneralInordertoarriveatanobjectiveevaluationofaduplicatingmaterial,Clauses9,10and11shallbereviewedbeforeanyfurtherstepsintheevaluationarebegun.5.2 MeltingtemperatureType1materialsWh

45、entestedinaccordancewith8.1,themeltingtemperatureshallnotexceedthemaximumstatedinthemanufacturersinstructions11c2J.5.3 PouringtemperatureType1materialsThemanufacturersrecommendedmaximumpouringtemperature11c)4)shallnotexceed54.5.4 ComponentcoloursType2materialsDifferentcomponentsintendedforuseinthesa

46、memixtureshallbesuppliedincontrastingcoloursinordertoprovideameansofdeterminingwhenthecomponentshavebeenthoroughlymixed.5.5 DetailreproductionWhentestedaccordingto82theduplicatingmaterialshallbeinaccordancewithFigure1,linebscribedonthetestblock,asapositivereproduction,forthefulllengthofthedistancebe

47、tweenlinesd1andd2,bothofwhichshallalsobecompletelyreproduced.5.6 Compatibilitywithrefractoryinvestmentand,ifapplicable,gypsumWhentestedinaccordancewith8.3,theduplicatingmaterialsshallimpartasmoothsurfaceto,andseparatecleanlyfrom,theinvestmentorgypsumproductpouredagainstit.Theinvestmentandgypsummater

48、ialpouredagainstthelinedsurfaceoftheduplicatingmaterialspecimenshallbeinaccordancewithFigure1,linecforthefulllengthofthedistancebetweenlinesd1andd2(seeFigure1).5.7 ElasticrecoveryWhentestedinaccordancewith8.4,theelasticrecoveryshallbeatleast96,50%.5.8 TearstrengthWhentestedinaccordancewith85thetearresistanceshallbeatleast0,3N/mmforTy