EN ISO 6872-2015 en Dentistry - Ceramic materials (Incorporates Amendment A1 2018)《牙科 陶瓷材料(ISO 6872 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 6872:2015Dentistry Ceramic materialsBS EN ISO 6872:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 6872:2015.It supersedes BS EN ISO 6872:2008 which is withdrawn.The UK participation in its preparation was entrusted to

2、 Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The Bri

3、tish Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 82314 5 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 Ju

4、ne 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6872 June 2015 ICS 11.060.10 Supersedes EN ISO 6872:2008English Version Dentistry - Ceramic materials (ISO 6872:2015) Mdecine bucco-dentaire - Matriaux cramiques

5、 (ISO 6872:2015) Zahnheilkunde - Keramische Werkstoffe (ISO 6872:2015) This European Standard was approved by CEN on 23 April 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stan

6、dard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application 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 a

7、ny other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Rep

8、ublic, 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, Sweden, Switzerland, Turkey and United Kingdom. EUROPEA

9、N COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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 for CEN national Members. Ref. No. EN ISO 6872:2015 EBS E

10、N ISO 6872:2015EN ISO 6872:2015 (E) 3 Foreword This document (EN ISO 6872:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” incollaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of

11、a national standard, either by publication of an identicaltext or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawnat the latest by December 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject o

12、f patentrights. 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 followingcountries are bound to implement this Eur

13、opean Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, 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, Slove

14、nia, Spain, 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. BS EN ISO 6872:2015ISO 6872:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions .

15、 13.1 Material . 13.2 Processing . 33.3 Properties 44 Types, classes, and their identification . 45 Requirements 65.1 Uniformity . 65.2 Freedom from extraneous materials 65.3 Mixing and condensation properties of type I ceramics . 65.4 Physical and chemical properties . 65.5 Biocompatibility 65.6 Sh

16、rinkage factor . 66 Sampling 66.1 Type I ceramics . 66.2 Type II ceramics . 77 Test methods . 77.1 Preparation of test specimens . 77.1.1 Components of test specimens (type I ceramics) 77.1.2 Apparatus for mixing . 77.1.3 Method of mixing . 77.1.4 Procedure for specimen fabrication 77.1.5 Firing 87.

17、2 Radioactivity of dental ceramic 87.2.1 Preparation of samples 87.2.2 Counting procedure. 87.2.3 Assessment of results 87.3 Flexural strength . 87.3.1 Three-point and four-point bending tests . 87.3.2 Biaxial flexure test (piston-on-three-ball test) .127.4 Linear thermal expansion coefficient . 147

18、.4.1 Apparatus 147.4.2 Preparing of test specimens (type I and type II ceramics) .147.4.3 Dilatometric measurement 147.4.4 Assessment of results .147.5 Glass transition temperature . 147.5.1 Operating procedure .147.5.2 Assessment of results .157.6 Chemical solubility . 157.6.1 Reagent 157.6.2 Appar

19、atus 157.6.3 Preparation of test specimens . 167.6.4 Procedure 167.6.5 Calculation and assessment of results .168 Information and instructions .168.1 Information . 168.1.1 General. 168.1.2 Type I Ceramics 16 ISO 2015 All rights reserved iiiContents PageBS EN ISO 6872:2015ISO 6872:2015(E)8.1.3 Type I

20、I ceramics 168.2 Instructions for use 179 Packaging, marking, and labelling 179.1 Packaging 179.2 Marking and labelling 17Annex A (informative) Fracture toughness .19Annex B (informative) Weibull statistics 26Bibliography .28iv ISO 2015 All rights reservedBS EN ISO 6872:2015ISO 6872:2015(E)ForewordI

21、SO (the International Organization 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 c

22、ommittee has been established has the 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 electr

23、otechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was dra

24、fted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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 ri

25、ghts. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not consti

26、tute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe comm

27、ittee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.This fourth edition cancels and replaces the third edition (ISO 6872:2008), which has been technically revised with the following changes: new edition of ISO 23146:2012 for fracture toughness by

28、SEVNB has been added as an alternative in Annex A. It has a rigorous procedure developed by ISO/TC 206, Fine ceramics; 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;

29、 maximum chamfer size on bend bars has been reduced for the case of the thin specimens; recommendations to grind lengthwise were added to the bend bar preparation step in 7.3.1.2.2; the Y equations for SEVNB fracture toughness in 3point have been refined and expanded to cover more configurations; mo

30、dification to Table 1 changing “aesthetic” to “monolithic”. ISO 2015 All rights reserved vBS EN ISO 6872:2015ISO 6872:2015(E)IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that i

31、n assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.vi ISO 2015 All rights reservedBS EN ISO 6872:2015Dentistry Ceramic materials1 ScopeThis International Standard specifies the requirements and the corresponding test methods for dental ceramic mat

32、erials 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 references, only the edition cited applies. For undated refe

33、rences, 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 for temperature measurement with separate thermocouple3 T

34、erms 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 temperature and is normally applied to restore contact areas

35、 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 ceramicdentine ceramic having a high strength or saturation of the hue

36、 (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 porcelainpredominantly, glassy dental ceramic (3.1.4) material us

37、ed 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 dentineINTERNATIONAL STANDARD ISO 6872:2015(E) ISO 2015 All rights rese

38、rved 1BS EN ISO 6872:2015ISO 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 enamel3.1.8flam

39、e-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 e

40、xceed 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 microstr

41、ucture3.1.11glass-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 c

42、ompared 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

43、 dentine 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

44、 of 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

45、 applied.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 dentine2 ISO 2015

46、 All rights reservedBS EN ISO 6872:2015ISO 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 appli

47、ed to a metallic substructure, 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 ceramicdent

48、al ceramic (3.1.4) material 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 interna

49、lly or externally during 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 ceramic (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 at