DIN EN ISO 6872-2015 Dentistry - Ceramic materials (ISO 6872 2015) German version EN ISO 6872 2015《牙科 烤瓷材料(ISO 6872-2015) 德文版本EN ISO 6872-2015》.pdf

1、November 2015 English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.10!%G(F“2360535www.din.d

2、eDIN EN ISO 6872Dentistry Ceramic materials (ISO 6872:2015);English version EN ISO 6872:2015,English translation of DIN EN ISO 6872:2015-11Zahnheilkunde Keramische Werkstoffe (ISO 6872:2015);Englische Fassung EN ISO 6872:2015,Englische bersetzung von DIN EN ISO 6872:2015-11Mdecine bucco-dentaire Mat

3、riaux cramiques (ISO 6872:2015);Version anglaise EN ISO 6872:2015,Traduction anglaise de DIN EN ISO 6872:2015-11SupersedesDIN EN ISO 6872:2009-01www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.Document comprises 35 pages

4、10.15 DIN EN ISO 6872:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 6872:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible Germa

5、n body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-07 AA Keramiken. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO

6、 3696 DIN ISO 3696 ISO 13078 DIN EN ISO 13078 Amendments This standard differs from DIN EN ISO 6872:2009-01 as follows: a) the new edition of ISO 23146:2012 for fracture toughness by SEVNB has been added as an alter-native in Annex A. It has a rigorous procedure developed by ISO/TC 206 “Fine ceramic

7、s”; b) a restriction on the use of the SEVNB method for fracture toughness determination for 3Y-TZP has been added. In most cases, the notch cannot be made sharp enough with a razor blade; c) the maximum chamfer size on bend bars has been reduced for thin specimens; d) recommendations to grind lengt

8、hwise were added to the bend bar preparation step in 7.3.1.2.2; e) the Y equations for SEVNB fracture toughness in 3-point bending have been refined and expanded to cover more configurations; f) in Table 1 “aesthetic” has been replaced by “monolithic”. Previous editions DIN 13925: 1988-01 DIN EN ISO

9、 6872: 1999-03, 2009-01 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 13078, Dentistry Dental furnace Test method for temperature measurement with separate thermocouple DIN ISO 3696, Water for analytical laboratory use Specification and test methods EN

10、 ISO 6872June 2015ICS 11.060.10 Supersedes EN ISO 6872:2008English VersionDentistry - Ceramic materials (ISO 6872:2015)Mdecine bucco-dentaire - Matriaux cramiques(ISO 6872:2015)Zahnheilkunde - Keramische Werkstoffe (ISO 6872:2015)This European Standard was approved by CEN on 23 April 2015. CEN membe

11、rs are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on applicatio

12、n to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Manageme

13、nt Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, L

14、ithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide

15、for CEN national Members. Ref. No. EN ISO 6872:2015 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContentsPage Foreword .4 Introduction .5 1 Scope .6 2 Normative references6 3 Terms and definitions .6

16、 3.1 Material 6 3.2 Processing . 8 3.3 Properties 9 4 Types, classes, and their identification .9 5 Requirements 11 5.1 Uniformity 11 5.2 Freedom from extraneous materials 11 5.3 Mixing and condensation properties of type I ceramics . 11 5.4 Physical and chemical properties . 11 5.5 Biocompatibility

17、 11 5.6 Shrinkage factor . 11 6 Sampling . 11 6.1 Type I ceramics 11 6.2 Type II ceramics . 12 7 Test methods . 12 7.1 Preparation of test specimens . 12 7.1.1 Components of test specimens (type I ceramics) . 12 7.1.2 Apparatus for mixing 12 7.1.3 Method of mixing 12 7.1.4 Procedure for specimen fab

18、rication . 12 7.1.5 Firing . 13 7.2 Radioactivity of dental ceramic . 13 7.2.1 Preparation of samples 13 7.2.2 Counting procedure. 13 7.2.3 Assessment of results . 13 7.3 Flexural strength . 13 7.3.1 Three-point and four-point bending tests . 13 7.3.2 Biaxial flexure test (piston-on-three-ball test)

19、 17 7.4 Linear thermal expansion coefficient . 19 7.4.1 Apparatus 19 7.4.2 Preparing of test specimens (type I and type II ceramics) . 19 7.4.3 Dilatometric measurement 19 7.4.4 Assessment of results . 19 7.5 Glass transition temperature . 19 7.5.1 Operating procedure . 19 7.5.2 Assessment of result

20、s . 20 7.6 Chemical solubility . 20 7.6.1 Reagent . 20 7.6.2 Apparatus 20 7.6.3 Preparation of test specimens 21 7.6.4 Procedure 21 7.6.5 Calculation and assessment of results . 21 2DIN EN ISO 6872:2015-11 EN ISO 6872:2015 (E) 3DIN EN ISO 6872:2015-11EN ISO 6872:2015 (E)8 Information and instruction

21、s 21 8.1 Information 21 8.1.1 General 21 8.1.2 Type I Ceramics . 21 8.1.3 Type II ceramics 21 8.2 Instructions for use 22 9 Packaging, marking, and labelling . 22 9.1 Packaging 22 9.2 Marking and labelling 22 Annex A (informative) Fracture toughness . 24 Annex B (informative) Weibull statistics . 31

22、 Bibliography . 33 Foreword This document (EN ISO 6872:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standar

23、d, either by publication of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by December 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

24、 CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 6872:2008. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard

25、: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

26、 Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 6872:2015 has been approved by CEN as EN ISO 6872:2015 without any modification. 4DIN EN ISO 6872:2015-11 EN ISO 6872:2015 (E) IntroductionSpecific qualitative and quantitative requirements for freedom from biolo

27、gical hazard are not included in this International Standard, but it is recommended that in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.5DIN EN ISO 6872:2015-11EN ISO 6872:2015 (E)1 ScopeThis International Standard specifies the requirements

28、and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated ref

29、erences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3696, Water for analytical laboratory use Specification and test methodsISO 1942, Dentistry VocabularyISO 13078, Dentistry Dental furnace Test method

30、for temperature measurement with separate thermocouple3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1 Material3.1.1addition ceramicadd-on ceramiccorrection ceramicdental ceramic material which is fired at a reduced tem

31、perature and is normally applied to restore contact areas on a dental restoration or prosthesis 3.1.2aesthetic ceramicdental porcelain (3.1.5) or glass ceramic (3.1.10) having appropriate translucency and colour used to mimic the optical properties of natural teeth3.1.3chromatic dentin ceramicdentin

32、e ceramic having a high strength or saturation of the hue (color)3.1.4dental ceramicinorganic, non-metallic material which is specifically formulated for use when processed according to the manufacturers instructions to form the whole or part of a dental restoration or prosthesis3.1.5dental porcelai

33、npredominantly, glassy dental ceramic (3.1.4) material used mainly for aesthetics in a dental restoration or prosthesis3.1.6dentine ceramicdental ceramic (3.1.4) material used to form the overall shape and basic colour of a dental restoration or prosthesis simulating the natural tooth dentine6DIN EN

34、 ISO 6872:2015-11 EN ISO 6872:2015 (E) 3.1.7enamel ceramicdental ceramic (3.1.4) material used to overlay, either partially or wholly, the dentine ceramic (3.1.6) and also, to form the more translucent incisal third of a dental restoration or prosthesis simulating the natural tooth enamel3.1.8flame-

35、sprayed dental ceramicdental ceramic core or substructure layer formed via the technique of flame-spraying3.1.9fluorescent ceramicdental ceramic (3.1.4) material that absorbs radiant energy and emits it in the form of radiant energy of a different wavelength band all or most of whose wavelengths exc

36、eed that of the absorbed energyEXAMPLE Absorption of ultraviolet light with emission of blue light.3.1.10glass ceramic (dental)dental ceramic (3.1.4) material formed by the action of heat treatment on a glass in order to cause initiation and growth of a wholly or predominantly crystalline microstruc

37、ture3.1.11glass-infiltrated dental ceramicdental ceramic core or substructure layer which is porous and is subsequently densified by the infiltration of specialised glass at elevated temperature3.1.12glaze ceramicdental ceramic (3.1.4) material which is overlayed and fired at a lower temperature com

38、pared to dentine ceramic (3.1.6) or enamel ceramic (3.1.7) to produce a thin coherent sealed surface, the level of gloss being determined by the firing conditions3.1.13linerdental ceramic (3.1.4) material used on all ceramic substructure forming a layer that provides a background colour upon which d

39、entine or opaceous dentine can be applied to achieve overall aesthetics3.1.14modelling fluidliquid with which a dental ceramic powder is mixed in order to shape or model it into its required form prior to firing3.1.15modifying enamel ceramicenamel ceramic (3.1.7) used to modify the surface contour o

40、f a restoration, for example, add a contact, often fired at a lower temperature than the enamel ceramic or dentine ceramic3.1.16monolithic ceramicdental ceramic (3.1.4) that is substantially made of a single uniform materialNote 1 to entry: A thin layer of glaze (3.3.4) (staining technique) can be a

41、pplied.3.1.17opaceous dentine ceramicdental ceramic (3.1.4) material having a higher opacity than a dentine ceramic (3.1.6) material, but which can still be used to contribute to the overall shape and basic colour of a dental restoration or prosthesis simulating the natural tooth dentine7DIN EN ISO

42、6872:2015-11EN ISO 6872:2015 (E)3.1.18opalescent enamel ceramicenamel ceramic (3.1.7) material that scatters shorter wavelengths of light (e.g. blue) and transmits longer wavelengths of light (e.g. red)3.1.19opaque dental ceramicdental ceramic (3.1.4) material which when applied to a metallic substr

43、ucture, according to the manufacturers instructions, acts to bond to the metal surface forming a layer that provides a background colour and interface upon which other dental ceramic materials can be applied to achieve overall aesthetics3.1.20shoulder ceramicmargin ceramicdental ceramic (3.1.4) mate

44、rial used to form shape and colour at the marginal area of the dental restoration or prosthesis simulating natural tooth dentine in this area3.1.21stain ceramicdental ceramic powder or paste which is normally intensely coloured and which is formulated to be used either internally or externally durin

45、g the build-up of a dental restoration or prosthesis to simulate details within or on the surface as are found in natural teeth3.1.22substructure (core) dental ceramicpredominantly, polycrystalline dental ceramic material that forms a supporting substructure upon which one or more layers of dental c

46、eramic (3.1.4) or dental polymer material are applied, either partially or totally, to form a dental restoration or prosthesis3.2 Processing3.2.1air firing dental ceramicfiring of dental ceramics (3.1.4) under ambient atmospheric pressure3.2.2dental CAD/CAMcomputer-aided design/computer-aided manufa

47、cture (CAD/CAM) procedures to manufacture a dental restoration or prosthesis normally including the following stages: a) a digital scanning procedure of the model, wax-up, or intra-orally to produce a 3D data set; b) software manipulation of the 3D data set to design the prosthesis; c) a computer-di

48、rected machine tool that performs the manufacturing process3.2.3condensation of dental ceramicpowder process whereby a slurry of dental ceramic powder is vibrated to compact the powder prior to sintering3.2.4injectable, castable, or pressable dental ceramicdental ceramic (3.1.4) material, normally i

49、n the form of a pellet or ingot (often pre-sintered), designed for use in a specialised furnace which enables the ingot to be injected/cast/pressed into a mould prepared through the lost wax technique8DIN EN ISO 6872:2015-11 EN ISO 6872:2015 (E) 3.2.5sintering of a dental ceramicprocess whereby heat and potentially other process parameters, for example, mechanical or gas pressure, are applied to a ceramic powder or powder compact in order to densify the ceramic into its re