DIN EN ISO 9693-2-2016 Dentistry - Compatibility testing - Part 2 Ceramic-ceramic systems (ISO 9693-2 2016) German version EN ISO 9693-2 2016《牙科 兼容性测试 第2部分 陶瓷 陶瓷系统(ISO 9693-2-2016).pdf

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1、July 2016 English price group 10No 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!%XLS“2534148www.din.deDIN

2、 EN ISO 9693-2Dentistry Compatibility testing Part 2: Ceramic-ceramic systems (ISO 9693-2:2016);English version EN ISO 9693-2:2016,English translation of DIN EN ISO 9693-2:2016-07Zahnheilkunde Kompatibilittsprfung Teil 2: Keramik-Keramiksysteme (ISO 9693-2:2016);Englische Fassung EN ISO 9693-2:2016,

3、Englische bersetzung von DIN EN ISO 9693-2:2016-07Mdecine bucco-dentaire Essais de compatibilit Partie 2: Systmes cramo-cramiques (ISO 9693-2:2016);Version anglaise EN ISO 9693-2:2016,Traduction anglaise de DIN EN ISO 9693-2:2016-07Together with DIN EN ISO 9693-1:2012-06,supersedesDIN EN ISO 9693:20

4、00-12, withdrawn 2012-06www.beuth.deDocument comprises 16 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.06.16 DIN EN ISO 9693-2:2016-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 9693-2:2

5、016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Commit

6、tee NA 014-00-07 AA Keramiken. DIN EN ISO 9693 consists of the following parts, under the general title Dentistry Compatibility testing: Part 1: Metal-ceramic systems Part 2: Ceramic-ceramic systems The DIN Standards corresponding to the International Standards referred to in this document are as fo

7、llows: ISO 1942 DIN EN ISO 1942 ISO 6872 DIN EN ISO 6872 ISO 7405 DIN EN ISO 7405 ISO 9693-1 DIN EN ISO 9693-1 ISO 10993-1 DIN EN ISO 10993-1 Amendments This standard differs from DIN EN ISO 9693:2000-12 as follows: a) the standard now consists of two parts, Part 1 dealing with metal-ceramic systems

8、 (corresponds to ISO 9693:2000) and the new Part 2 covering ceramic-ceramic systems. Previous editions DIN EN ISO 9693: 1995-03, 2000-12 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6872, Dentistry Ceramic materials DIN EN ISO 7405, Dentistry Evaluati

9、on of biocompatibility of medical devices used in dentistry DIN EN ISO 9693-1, Dentistry Compatibility testing Part 1: Metal-ceramic systems DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system EUROPEAN STANDARD NORME EUROPENNE E

10、UROPISCHE NORM EN ISO 9693-2 March 2016 ICS 11.060.10 Supersedes EN ISO 9693:2000English Version Dentistry - Compatibility testing - Part 2: Ceramic-ceramic systems (ISO 9693-2:2016) Mdecine bucco-dentaire - Essais de compatibilit - Partie 2: Systmes cramo-cramiques(ISO 9693-2:2016) Zahnheilkunde -

11、Verbundprfung - Teil 2: Keramik-Keramiksysteme (ISO 9693-2:2016) This European Standard was approved by CEN on 13 December 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 standar

12、d 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 any

13、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 Republ

14、ic, 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 andUnited Kingdom. EUROPEAN CO

15、MMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9693-2:2016 EEurope

16、an foreword 3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Requirements 64.1 Biocompatibility 64.2 Physical properties 74.2.1 General 74.2.2 Thermal expansion 74.2.3 De-bonding/crack-initiation test (zirconia-porcelain only) 74.2.4 Thermal shock resistance 75 Sampling

17、 75.1 Substructure dental ceramic . 75.2 Dental porcelain . 76 Test methods . 76.1 Linear thermal expansion . 76.2 Glass transition temperature 76.3 De-bonding/crack-initiation test (zirconia-porcelain only) 86.3.1 Preparation of test specimens 86.3.2 Determination of fracture force 86.3.3 Test repo

18、rt 106.4 Thermal shock testing . 106.4.1 General. 106.4.2 Thermocycling test with fixed temperature interval. 106.4.3 Thermocycling test with increasing temperature interval . 117 Test report 12Bibliography . 14Contents PageDIN EN ISO 9693-2:2016-07 EN ISO 9693-2:2016 (E) 2Foreword 4European forewor

19、d This document (EN ISO 9693-2:2016) 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 standard, either by publication

20、 of an identical text or by endorsement, at the latest by September 2016, and conflicting national standards shall be withdrawn at the latest by September 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC sh

21、all not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9693:2000. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bu

22、lgaria, 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, Sweden, Switzerland,

23、Turkey and the United Kingdom. Endorsement notice The text of ISO 9693-2:2016 has been approved by CEN as EN ISO 9693-2:2016 without any modification. DIN EN ISO 9693-2:2016-07 EN ISO 9693-2:2016 (E) 3 ForewordISO (the International Organization for Standardization) is a worldwide federation of nati

24、onal 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 that committee. Internat

25、ional 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.The procedures used to develop this document and those intende

26、d 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 drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.is

27、o.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 rights. Details of any patent rights identified during the development of the document will

28、 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 constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressio

29、ns 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 committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthod

30、ontic materials.This first edition, together with ISO 9693-1, cancels and replaces ISO 9693:1999.This part of ISO 9693 replaces the bi-material portions of ISO 9693:1999 to focus only on the compatibility of veneering porcelains fired onto substrate ceramics. Tests of all ceramic materials for eithe

31、r metal or ceramic substructures are now contained in a global ceramics standard ISO 6872. Some elements of ISO 9693:1999 remain for all materials (e.g. measurement of thermal expansion coefficients) and one remains only for porcelain fired to zirconia (Schwickerath bond characterization test). New

32、requirements have been added for porcelain-ceramic systems, including thermal shock testing for ceramic-ceramic compatibility (allowing many protocols that are in widespread use within industry).ISO 9693 consists of the following parts, under the general title Dentistry Compatibility testing: Part 1

33、: Metal-ceramic systems Part 2: Ceramic-ceramic systemsDIN EN ISO 9693-2:2016-07 EN ISO 9693-2:2016 (E) 4 IntroductionDental porcelains and substructure ceramics are suitable for use in fabrication of all-ceramic dental restorations. Their compatibility under mechanical and thermal loading is essent

34、ial if they are to function in a prosthetic construction. This part of ISO 9693 sets out requirements and test methods for allowing the risks associated with masticatory forces and the oral environment to be assessed.Specific qualitative and quantitative requirements for freedom from biological haza

35、rds are not included in this International Standard, but, in assessing possible biological hazards, reference can be made to ISO 10993-1 and ISO 7405.DIN EN ISO 9693-2:2016-07 EN ISO 9693-2:2016 (E) 5 1 ScopeThis part of ISO 9693 specifies requirements and test methods to assess the compatibility of

36、 ceramic-ceramic materials used for dental restorations by testing composite structures.The requirements of this part of ISO 9693 apply when different ceramic components are used in combination. Compliance cannot be claimed for either ceramic alone.For requirements of ceramic materials, see ISO 6872

37、.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 references, the latest edition of the referenced document (including any amend

38、ments) applies.ISO 1942, Dentistry VocabularyISO 6872:2015, Dentistry Ceramic materials3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and ISO 6872 and the following apply.3.1ceramic veneerfull structure of fired ceramic layers applied to a subst

39、rate material3.2conditioningprocess of treating the ceramic substructure to enhance the bonding of the veneer ceramic3.3linersubstance which, when applied to the ceramic substructure and fired under appropriate time-temperature conditions, may improve aesthetics and/or adherence of ceramic to the co

40、ated ceramic surface4 Requirements4.1 BiocompatibilitySee the Introduction for guidance on biocompatibility.DIN EN ISO 9693-2:2016-07 EN ISO 9693-2:2016 (E) 6 4.2 Physical properties4.2.1 GeneralThe individual materials shall fulfil the requirements of ISO 6872 and the thermo-mechanical compatibilit

41、y tests shall be performed where applicable. The materials shall also comply with the requirements of 4.2.2 to 4.2.4.4.2.2 Thermal expansionThe coefficients of thermal expansion of the substructure ceramic and the veneering ceramic shall have been determined according to ISO 6872:2015, 7.4.It is imp

42、erative that the same protocol be used for both the veneering and ceramic substructure (e.g. same lowest temperature).Test in accordance with 6.1.4.2.3 De-bonding/crack-initiation test (zirconia-porcelain only)When tested according to 6.3, the de-bonding/crack-initiation strength of the zirconia mat

43、erial and at least one specified (named) dental veneering ceramic present shall be greater than 20 MPa. Test in accordance with 6.3.4.2.4 Thermal shock resistanceAt least one test for resistance to thermal shock shall be performed according to 6.4.2 or 6.4.3.Note The measured values for coefficients

44、 of linear thermal expansion are compared with the manufacturers values as a means of quality control, but the values cannot provide an assurance that the ceramic substructure and ceramic veneer are compatible.5 Sampling5.1 Substructure dental ceramicThe sample shall be adequate to prepare the speci

45、mens for testing in accordance with this International Standard. All of the material shall be from the same lot.5.2 Dental porcelainTake a sufficient amount of veneering ceramic to carry out the necessary tests in accordance with this International Standard. Perform test with a colour/shade most com

46、monly used. All of the material tested shall be from the same lot.6 Test methods6.1 Linear thermal expansionSee ISO 6872:2015, 7.4.6.2 Glass transition temperatureSee ISO 6872:2015, 7.5.DIN EN ISO 9693-2:2016-07 EN ISO 9693-2:2016 (E) 7 6.3 De-bonding/crack-initiation test (zirconia-porcelain only)6

47、.3.1 Preparation of test specimensPrepare six zirconia specimens (25 1) mm (3 0,1) mm (0,5 0,05) mm in accordance with the manufacturers procedure for processing the substructures for prostheses. Condition the specimens, observing the manufacturers instructions. According to the manufacturers instru

48、ctions, add dental porcelain to each specimen to form a total ceramic thickness of (1,1 0,1) mm after firing (see Figure 1). The ceramic layer shall have a rectangular shape and extend the full 3 mm width of the substrate.If necessary add additional dental porcelain to obtain the required thickness and shape, and fire it. Carefully trim the re