BS EN ISO 9693-2-2016 Dentistry Compatibility testing Ceramic-ceramic systems《牙科 兼容性测试 陶瓷 陶瓷系统》.pdf

1、BSI Standards PublicationBS EN ISO 9693-2:2016Dentistry CompatibilitytestingPart 2: Ceramic-ceramic systemsBS EN ISO 9693-2:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9693-2:2016. Together with BS EN ISO 9693-1:2012 it supersedes BS EN ISO 9693:200

2、0 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodontic materials.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purpor

3、t to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 78980 9ICS 11.060.10Compliance with a British Standard cannot confer immunity from legal obligatio

4、ns.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2016.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9693-2 March 2016 ICS 11.060.10 Supersedes EN ISO 9693:2

5、000English 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 - Verbundprfung - Teil 2: Keramik-Keramiksysteme (ISO 9693-2:2016) This Europea

6、n 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 standard without any alteration. Up-to-date lists and bibliographical references con

7、cerning 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 other language made by translation under the responsibility of a CEN member i

8、nto 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,

9、 Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITE

10、E 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 EBS EN ISO 9693-2:2016EN ISO 9693-2:2016 (E) 3 European foreword This document (EN I

11、SO 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 of an identical text

12、 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 shall not be held respo

13、nsible 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, Bulgaria, Croatia, Cypr

14、us, 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, Turkey and the United

15、 Kingdom. Endorsement notice The text of ISO 9693-2:2016 has been approved by CEN as EN ISO 9693-2:2016 without any modification. BS EN ISO 9693-2:2016ISO 9693-2:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 14.1 Biocompatibility 14.2 Ph

16、ysical properties 24.2.1 General 24.2.2 Thermal expansion 24.2.3 De-bonding/crack-initiation test (zirconia-porcelain only) 24.2.4 Thermal shock resistance 25 Sampling 25.1 Substructure dental ceramic . 25.2 Dental porcelain . 26 Test methods . 26.1 Linear thermal expansion . 26.2 Glass transition t

17、emperature 26.3 De-bonding/crack-initiation test (zirconia-porcelain only) 36.3.1 Preparation of test specimens 36.3.2 Determination of fracture force 36.3.3 Test report . 56.4 Thermal shock testing 56.4.1 General 56.4.2 Thermocycling test with fixed temperature interval 56.4.3 Thermocycling test wi

18、th increasing temperature interval 67 Test report . 7Bibliography 9 ISO 2016 All rights reserved iiiContents PageBS EN ISO 9693-2:2016ISO 9693-2:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The wor

19、k 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. International organizations, governmental and non-governme

20、ntal, 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 intended for its further maintenance are described in the

21、 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.iso.org/directives).Attention is drawn to the possib

22、ility 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 be in the Introduction and/or on the ISO list of

23、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 expressions related to conformity assessment, as well as in

24、formation 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, Prosthodontic materials.This first edition, together with

25、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 either metal or ceramic substructures are now contained

26、 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 requirements have been added for porcelain-ceramic

27、 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: Metal-ceramic systems Part 2: Ceramic-ceramic sy

28、stemsiv ISO 2016 All rights reservedBS EN ISO 9693-2:2016ISO 9693-2:2016(E)IntroductionDental porcelains and substructure ceramics are suitable for use in fabrication of all-ceramic dental restorations. Their compatibility under mechanical and thermal loading is essential if they are to function in

29、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 hazards are not included in this In

30、ternational Standard, but, in assessing possible biological hazards, reference can be made to ISO 10993-1 and ISO 7405. ISO 2016 All rights reserved vBS EN ISO 9693-2:2016BS EN ISO 9693-2:2016Dentistry Compatibility testing Part 2: Ceramic-ceramic systems1 ScopeThis part of ISO 9693 specifies requir

31、ements and test methods to assess the compatibility of 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 alo

32、ne.For requirements of ceramic materials, see ISO 6872.2 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 e

33、dition of the referenced document (including any amendments) 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 veneerful

34、l structure of fired ceramic layers applied to a substrate 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 im

35、prove aesthetics and/or adherence of ceramic to the coated ceramic surface4 Requirements4.1 BiocompatibilitySee the Introduction for guidance on biocompatibility.INTERNATIONAL STANDARD ISO 9693-2:2016(E) ISO 2016 All rights reserved 1BS EN ISO 9693-2:2016ISO 9693-2:2016(E)4.2 Physical properties4.2.

36、1 GeneralThe individual materials shall fulfil the requirements of ISO 6872 and the thermo-mechanical compatibility 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 s

37、ubstructure ceramic and the veneering ceramic shall have been determined according to ISO 6872:2015, 7.4.It is imperative 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 (

38、zirconia-porcelain only)When tested according to 6.3, the de-bonding/crack-initiation strength of the zirconia material 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 re

39、sistance to thermal shock shall be performed according to 6.4.2 or 6.4.3.Note The measured values for coefficients 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 cerami

40、c veneer are compatible.5 Sampling5.1 Substructure dental ceramicThe sample shall be adequate to prepare the specimens 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

41、 out the necessary tests in accordance with this International Standard. Perform test with a colour/shade most commonly 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.

42、2 ISO 2016 All rights reservedBS EN ISO 9693-2:2016ISO 9693-2:2016(E)6.3 De-bonding/crack-initiation test (zirconia-porcelain only)6.3.1 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 su

43、bstructures for prostheses. Condition the specimens, observing the manufacturers instructions. According to the manufacturers instructions, 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

44、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 rectangular shape with a disc. If necessary remove ceramic from the side of the substructure zirconia in order to keep its ov

45、erall shape.Submit each specimen to a glaze firing in accordance with the manufacturers instructions.Dimensions in millimetresFigure 1 Test specimen configuration6.3.2 Determination of fracture force6.3.2.1 ApparatusFlexural-strength testing machine for three-point bending, having a span between sup

46、ports of 20 mm and capable of a cross-head-speed of (1,5 0,5) mm/min. Supports and bending piston shall be rounded to a radius of 1,0 mm.6.3.2.2 ProcedureThe fired specimens are placed in the bending apparatus with the veneering ceramic positioned symmetrically on the side opposite to the applied lo

47、ad. The force is applied at a constant cross-head speed of (1,5 0,5) mm/min and recorded up to failure. The fracture force Ffail(in newtons) for each of six specimens is measured for specimens failing by a de-bonding crack occurring at one end of the ceramic layer. Specimens failing by cracks in the

48、 middle of the ceramic layer shall be replaced until six appropriate specimens are obtained.6.3.2.3 Evaluation of de-bonding/crack-initiation strength6.3.2.3.1 GeneralThe fracture force Ffailhas to be multiplied with a coefficient k. Coefficient k can be read from Figure 2. The coefficient k is a fu

49、nction of the thickness of the zirconia substrate dZ(0,5 0,05) mm, and the value of Youngs modulus EZof the zirconia substrate.To read the value k for a certain thickness dZ, first pick the curve for the proper value EZ, then read the value k from the picked curve for the thickness dZ. ISO 2016 All rights reserved 3BS EN ISO 9693-2:2016ISO 9693-2:2016(E)The de-bonding/crack-initiation strength bis calculated using the equation:b =k FfailThe ceramic-ceramic system passes the test if four specimens out of six, or mo