BS EN ISO 14233-2003 Dentistry - Polymer-based die materials《牙科学 聚合物基模塑料》.pdf

1、BRITISH STANDARD BS EN ISO 14233:2003 Incorporating Corrigendum No. 1 Dentistry Polymer-based die materials The European Standard EN ISO 14233:2003 has the status of a British Standard ICS 11.060.10 BS EN ISO 14233:2003 This British Standard was published under the authority of the Standards Policy

2、and Strategy Committee on 27 March 2003 BSI 5 August 2003 ISBN 0 580 41500 7 National foreword This British Standard is the official English language version of EN ISO 14233:2003. It is identical with ISO 14233:2003. The UK participation in its preparation was entrusted by Technical Committee CH/106

3、, Dentistry, 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 referre

4、d to in 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 provisio

5、ns of a 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

6、 proposals 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

7、ii to v, a blank page, pages 1 to 10, 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 14635 Corrigendum No. 1 5 August 2003 Replacing the EN ISO foreword page

8、 and incorporating the Annex ZA pageEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO14233 March2003 ICS11.060.10 Englishversion DentistryPolymerbaseddiematerials(ISO14233:2003) ArtdentaireProduitsbasedepolymrepourmatrices (ISO14233:2003) ZahneilkundeModellstumpfwerkstoffeausKunststoffe (ISO14233

9、:2003) ThisEuropeanStandardwasapprovedbyCENon21February2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational stan

10、dardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe offici

11、al versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,SlovakRepublic,Spain,Sweden,Switzerland and UnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEU

12、ROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO14233:2003ECORRECTED20030716 Foreword Thisdocument(ENISO14233:2003)hasbeenpreparedbyTechnicalCommi

13、tteeISO/TC106 “Dentistry“incollaborationwithTechnicalCommitteeCEN/TC55“Dentistry“,thesecretariatof whichisheldbyDIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbySeptember2003,andconflictingnational standardsshallbewit

14、hdrawnatthelatestbySeptember2003. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherl

15、ands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerlandand theUnitedKingdom. Endorsementnotice ThetextofISO14233:2003hasbeenapprovedbyCENasENISO14233:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO14233:2003 Reference number ISO 14233:

16、2003(E)INTERNATIONAL STANDARD ISO 14233 First edition 2003-03-15 Dentistry Polymer-based die materials Art dentaire Produits base de polymre pour matrices ENISO14233:2003ENISO14233:2003iiIS:33241 O3002(E) I SO 3002 All irhgts seredevr iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative

17、 references . 1 3 Terms and definitions. 1 4 Requirements 1 5 Sampling 2 6 Test methods. 2 7 Manufacturers instructions and user information 8 8 Packaging and marking 9 Bibliography . 10 ENISO14233:2003iiiIS:33241 O3002(E) vi I SO 3002 All irhgts seredevrForeword ISO (the International Organization

18、for Standardization) is a worldwide 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 t

19、he right to be represented on that 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. Interna

20、tional Standards are drafted in accordance 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. Publicatio

21、n as an International Standard requires 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

22、. ISO 14233 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. ENISO14233:2003ivIS:33241 O3002(E) I SO 3002 All irhgts seredevr vIntroduction Polymer-based die materials are not covered by ISO 6873 1 , which describes only gypsum-based die material

23、s. Hence the need for this International Standard, whose requirements have been designed to delineate satisfactory polymer-based die materials and exclude unsatisfactory ones. It is anticipated that both manufacturer and user can apply this International Standard as a basis for producing or obtainin

24、g satisfactory products and results. ENISO14233:2003vINTENRATIONAL TSANDADR IS:33241 O3002(E)I SO 3002 All irhgts seredevr 1Dentistry Polymer-based die materials 1 Scope This International Standard gives compositional, performance, user-information, packaging and marking, and testing requirements fo

25、r polymer-based die materials used in dentistry. It is applicable to die materials having a polymeric matrix as their principal constituent. Polymer-based die materials are used in the dental laboratory mainly to produce casts from dental impressions for the manufacture of fixed or removable restora

26、tions. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4823, Dentistry

27、 Elastomeric impression materials ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the following terms and defi

28、nitions apply. 3.1 polymer-based die material material which is primarily an epoxy resin, polyurethane or an acrylate resin and (especially epoxy resins and polyurethane) which contains metallic, metaloxides and/or inorganic fillers 4 Requirements 4.1 Components The components of the polymer-based d

29、ie material shall be free of extraneous matter and shall show no sign of deterioration. When treated according to the manufacturers instructions, the material shall form a solid suitable for the intended purpose. Testing shall be carried out in accordance with 6.2. 4.2 Working time The working time

30、in minutes of the polymer-based die material shall be not less than that stated by the manufacturer. At the manufacturers stated working time, the requirement of 4.4 shall be met. Testing shall be carried out in accordance with 6.3. ENISO14233:20031IS:33241 O3002(E) 2 I SO 3002 All irhgts seredevr4.

31、3 Setting time At the manufacturers stated setting time the Vickers hardness of the polymer-based die material shall be not less than 6 HV 0,2. Testing shall be carried out in accordance with 6.4. 4.4 Detail reproduction The polymer-based die material shall reproduce a line 20 m wide. Testing shall

32、be carried out in accordance with 6.3. 4.5 Linear dimensional change The linear dimensional change of the polymer-based die material after 24 h shall be less than 1,0 %. Testing shall be carried out in accordance with 6.3. 4.6 Vickers hardness The Vickers hardness of the polymer-based die material d

33、etermined 24 h after the preparation of the specimens shall be not less than that stated by the manufacturer. Testing shall be carried out in accordance with 6.5. 5 Sampling The test sample shall consist of one or more retail packages from the same batch and contain sufficient (approximately 50 ml)

34、material to carry out the specified tests plus any necessary repetition of the tests. 6 Test methods 6.1 General 6.1.1 Test conditions Prepare and test the specimens at (23 2) C and at a relative humidity of not less than 30 %. 6.1.2 Preparation of test specimens Mix and process the polymer-based di

35、e material in accordance with the manufacturers instructions. 6.2 Visual inspection Use visual inspection to determine compliance with 4.1 and Clauses 7 and 8. 6.3 Working time, detail reproduction and linear dimensional change 6.3.1 Reagents and/or materials 6.3.1.1 Elastomeric impression material,

36、 compatible with the die material and conforming to ISO 4823. ENISO14233:20032IS:33241 O3002(E) I SO 3002 All irhgts seredevr 36.3.2 Apparatus 6.3.2.1 Ruled test block, as shown in Figure 1. 6.3.2.2 Ring mould, as shown in Figure 2. 6.3.2.3 Split mould, as shown in Figure 3. 6.3.2.4 Glass plate, (50

37、 5) mm (50 5) mm (4 1) mm, dusted with talcum powder for storage of the impression. 6.3.2.5 Lens, for (6 1) magnification with light at low-angle illumination. 6.3.2.6 Measuring microscope, accurate to 0,01 mm. ENISO14233:20033IS:33241 O3002(E) 4 I SO 3002 All irhgts seredevrDimensions in millimetre

38、s Tolerances: 0,1 mm, unless otherwise specified Surface roughness (values in micrometres) of ruled surface 0,1; other surfaces 0,4. Key 1 50 m line; 2 20 m line; 3 75 m line; 4 75 m transverse lines aEnlarged view. Figure 1 Ruled test block Side view, top view and sectional view AA ENISO14233:20034

39、IS:33241 O3002(E) I SO 3002 All irhgts seredevr 5Dimensions in millimetres Tolerances: 0,1 mm, unless otherwise specified Surface roughness (values in micrometres) 0,4. Figure 2 Ring mould Cross-section and top view ENISO14233:20035IS:33241 O3002(E) 6 I SO 3002 All irhgts seredevrDimensions in milli

40、metres Tolerances: 0,1 mm, unless otherwise specified Surface roughness (values in micrometres) 0,4. Figure 3 Split mould Cross-section and top view 6.3.3 Procedure 6.3.3.1 Clean the ruled test block (6.3.2.1) with a solvent before use but do not use a separating medium. Place the ring mould (6.3.2.

41、2) on the ruled test block. Use the elastomeric impression material (6.3.1.1) according to the manufacturers instructions. Immediately place the impression material into the mould within 15 s. Immediately cover the mould with the glass plate (6.3.2.4), applying sufficient load to extrude excess mate

42、rial, and bring the glass plate into contact with the ring mould. After twice the setting time of the elastomeric impression material, as stated by its manufacturer, remove the plate and separate the ring mould from the test block so that the impression stays in the ring mould. Use the lens for (6 1

43、) magnification with light at low-angle illumination (6.3.2.5) and inspect the lines 1, 2 and 3 on the impression for full continuous reproduction between the lines 4. If the lines are not fully continuous, repeat the impression. Prepare three satisfactory impressions. 6.3.3.2 Dust the unlined side

44、of each impression with talcum powder. Transfer the ring mould with the impression to the glass plate, also dusted with talcum powder, with the lines facing up. Store the ring mould with the impression for 24 h in accordance with 6.1.1. Afterwards, measure the distance between the transverse lines 4

45、 along lines 1, 2 and 3 on the impression with the measuring microscope (6.3.2.6) using low- angle illumination. Record the measurement to the nearest 0,01 mm as reading L 1 . Place the ring mould with the impression on a flat surface. Close the slit of the split mould (6.3.2.3) and place it on the

46、ring mould. Mix the polymer-based die material according to the manufacturers instructions. At the manufacturers stated working time, fill the split mould with the mixed polymer-based die material. Store the assembly with the polymer-based die material specimens in accordance with 6.1.1. At the manu

47、facturers stated setting time, remove the polymer-based die material specimen from the impression and the split mould. Prepare a polymer-based die material specimen from each of the three satisfactory impressions. ENISO14233:20036IS:33241 O3002(E) I SO 3002 All irhgts seredevr 76.3.3.3 Use the lens

48、for (6 1) magnification with light at low-angle illumination (6.3.2.5) and observe the reproduction of the 20 m wide line of the ruled test block (Figure 1, Line 2). The portion of the 20 m wide line between the two transverse lines 4 shall be reproduced continuously. Each polymer-based die material specimen shall be in accor