EN ISO 14356-2003 en Dentistry Duplicating material《牙科学 复制材料ISO 14356-2003》.pdf

1、BRITISH STANDARD BS EN ISO 14356:2003 Incorporating Corrigendum No. 1 Dentistry Duplicating material The European Standard EN ISO 14356:2003 has the status of a British Standard ICS 11.060.10 BS EN ISO 14356:2003 This British Standard was published under the authority of the Standards Policy and Str

2、ategy Committee on 24 March 2003 BSI 6 August 2003 ISBN 0 580 41444 2 National foreword This British Standard is the official English language version of EN ISO 14356:2003. It is identical with ISO 14356:2003. The UK participation in its preparation was entrusted by Technical Committee CH/106, Denti

3、stry, to Subcommittee CH/106/2, Prosthodontic materials, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in

4、 this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a

5、 contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or propos

6、als for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to i

7、v, pages 1 to 30, the Annex ZA page and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14634 Corrigendum No. 1 6 August 2003 Replacing the EN ISO foreword page and Annex ZA page E

8、UROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO14356 March2003 ICS11.060.10 Englishversion DentistryDuplicatingmaterial(ISO14356:2003) ArtdentaireProduitspourduplication(ISO14356:2003) ThisEuropeanStandardwasapprovedbyCENon21February2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegul

9、ationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversion

10、s(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Gre

11、ece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,SlovakRepublic,Spain,Sweden,Switzerland and UnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexp

12、loitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO14356:2003ECORRECTED20030716 Foreword Thisdocument(ENISO14356:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC106 “Dentistry“incollaborationwithTechnicalCommitteeCEN/TC55“Dentistry“,thesecretariatof whichisheldbyDIN. T

13、hisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbySeptember2003,andconflictingnational standardsshallbewithdrawnatthelatestbySeptember2003. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof the

14、followingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerlandand theUnitedKingdom. Endorsementnotice ThetextofISO14356:2003ha

15、sbeenapprovedbyCENasENISO14356:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinannexZA(normative). ENISO14356:2003 Reference number ISO 14356:2003(E)INTERNATIONAL STANDARD ISO 14356 First edition 2003-03-01 Dentistry Duplicating material Art dentaire Produits

16、pour duplication ENISO14356:2003ENISO14356:2003iiIS:65341 O3002(E) I SO 3002 All irhgts seredevr iiiContents Page Foreword iv 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Classification by types . 4 5 Material characteristics and properties Requirements 4 5.1 General. 4 5.2 Melt

17、ing temperature Type 1 materials 4 5.3 Pouring temperature Type 1 materials. 4 5.4 Component colours Type 2 materials 4 5.5 Detail reproduction . 4 5.6 Compatibility with refractory investment (and gypsum if applicable) 5 5.7 Elastic recovery. 5 5.8 Tear strength . 5 5.9 Resistance to fungal growth

18、Type 1 materials only . 5 6 Sampling 5 7 Test methods General 5 7.1 Laboratory conditions 5 7.2 Verification of apparatus function. 5 7.3 Specimen preparation and testing 5 7.4 Pass/fail determinations. 6 7.5 Expression of test results 6 8 Specific specimen preparation and test procedures 6 8.1 Melt

19、ing temperature test Type 1 materials only 6 8.2 Detail reproduction test 7 8.3 Test for compatibility with refractory investment (and gypsum if applicable). 8 8.4 Elastic recovery test . 9 8.5 Tear strength test 12 8.6 Fungal growth resistance test Type 1 agar materials only 15 9 Requirements for p

20、ackaging 15 10 Requirements for labelling. 15 11 Instructions for use Required information 16 Annex A (informative) Optional procedure for tear test . 27 ENISO14356:2003iiiIS:65341 O3002(E) vi I SO 3002 All irhgts seredevrForeword ISO (the International Organization for Standardization) is a worldwi

21、de federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on tha

22、t committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in a

23、ccordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard re

24、quires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14356 was prepared by Techn

25、ical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. ENISO14356:2003ivINTENRATIONAL TSANDADR IS:65341 O3002(E)I SO 3002 All irhgts seredevr 1Dentistry Duplicating material 1 Scope This International Standard specifies requirements and tests for the duplicating materials

26、used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refere

27、nces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942 (all parts), Dental vocabulary ISO 6873, Dental gypsum products ISO 7490, Dental gypsum-bonded casting investments ISO 9694, Dental phosphate-bonde

28、d casting investments ISO 11245, Dental restorations Phosphate-bonded refractory die materials ISO 11246, Dental ethyl silicate bonded casting investments 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 block out to

29、flow or mould waxes and/or materials such as cements, clays and polymeric materials into undercut areas on a master model, and then shape them so as to leave only those undercuts that are essential to the subsequent steps in producing a prosthesis that will fit and function optimally NOTE A blocked-

30、out master model may also include other surface modifications needed relative to construction of a prosthesis. 3.2 double boiler container system, usually in three parts, in which the upper container fits into the lower container such that boiling water in the lower container heats the contents of t

31、he lid-covered upper container ENISO14356:20031IS:65341 O3002(E) 2 I SO 3002 All irhgts seredevr3.3 duplicating material elastic material used to make flexible negative copy impressions or moulds of objects (models or casts) into which a mix of a refractory investment, or another mixture intended fo

32、r a similar purpose, can be poured to produce a positive copy of the original object 3.4 non-reversible duplicating material material which converts from a pourable consistency to a gel or rubber-like state and which thereafter cannot be returned to the pourable consistency for repeated use 3.5 reve

33、rsible duplicating material material which can be recycled for more than one use by changing it, by means of heating, from an elastic gel state to a pourable consistency, and then returning it to the gel state by cooling 3.6 duplicating process for making metal and ceramic objects method for making

34、positive copies of master models from a negative mould NOTE 1 The process is carried out according to the following steps: master model is blocked out, duplicating material is poured around blocked-out master model and allowed to gel or set, master model is separated from the duplicating material, l

35、eaving a flexible mould having surfaces that constitute a negative copy of the surfaces of the master model, an investment mixture is poured into the mould to form a refractory model on which polymeric or wax patterns, or both, can be laid down to form the shapes desired in metal or ceramic castings

36、 or on which slurries of porcelain can be applied for forming desired shapes. NOTE 2 Gypsum product mixtures or other mixtures may be poured into the moulds to form copies of master models needed for other purposes. 3.7 effective setting time for materials setting at or near oral or room temperature

37、 time measured from the commencement of mixing components of a material together, or otherwise activating the chemistry involved, to the time at which the activated material has developed the properties (elasticity, hardness, etc.) that will permit it to be used with optimal effectiveness in a subse

38、quent step or for its intended purpose 3.8 functional life reversible duplicating material number of times a material can be recycled for use, if handled and used according to the manufacturers instructions, without loss of the properties required to ensure that the material is fit for the purpose i

39、ntended 3.9 gelation agar duplicating material transition of a material from a relatively fluid consistency to a gel state in which the material has developed the elastic properties needed for its intended purpose 3.10 immediate container packaging component having internal surfaces in direct contac

40、t with the material contained ENISO14356:20032IS:65341 O3002(E) I SO 3002 All irhgts seredevr 3NOTE An immediate container may be a unlabelled container protected by more durable outer packaging, such as a can, carton or drum. If strong enough to protect its contents without outer packaging, an imme

41、diate container can serve as a primary container on which labelling may be required. 3.11 initial setting time time measured from the commencement of mixing components of a material together, or otherwise activating the chemistry involved, to the time at which a test procedure, conducted at a specif

42、ied temperature, indicates that the mixture has begun to set at a relatively rapid rate, thus indicating that the effective setting time will be reached at some predictable time thereafter NOTE Initial setting times stated in the manufacturers instructions are useful to test operators, users, and st

43、andards developers because: they can often be used for determining whether a product is of a quality suitable for testing or use. For example, if the initial setting time found by the test operator or user corresponds closely to that stated in the instructions, it can usually be assumed that the pro

44、duct is suitable for testing or use. they can be helpful in the development of standards for certain materials if there is a need for a standard to identify a reference point in time that can be used as a basis for specifying when certain subsequent procedures should begin. 3.12 investment casting p

45、owdered refractory material containing a binder, to be mixed with a specified liquid to form a slurry that can be poured into a mould made of duplicating material where it is allowed to harden to form a heat- resistant positive copy of a master model, or which can be poured around patterns to form a

46、 heat-resistant mould used for forming ceramic or metal objects 3.13 master model definitive cast fixed and removable denture construction positive copy of the hard and/or soft tissues of a dental arch, usually made by pouring a gypsum product slurry into an impression made of a dental arch 3.14 mel

47、t agar reversible duplicating material change a material, by heating, from a gel state to a pourable fluid state 3.15 outer package wrapping or carton which is used to cover one or more immediate or primary containers in preparation for retail marketing and which may be required by law or Internatio

48、nal Standard to bear specified labelling information 3.16 pouring temperature duplicating material temperature of the material designated in the manufacturers instructions for pouring the material around an object to be duplicated 3.17 primary container retail marketing packaging component which may or may not be covered by an outer package and which may be required by law or Internatio