EN ISO 9693-1-2012 en Dentistry - Compatibility testing - Part 1 Metal-ceramic systems《牙科学 兼容性测试 金属陶瓷体系》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 9693-1:2012Dentistry CompatibilitytestingPart 1: Metal-ceramic systems (ISO9693-1:2012)BS EN ISO 9693-1:2012 BRITISH STANDARDNational forewordThis British Standard is t

2、he UK implementation of EN ISO9693-1:2012. Together with BS EN ISO 9693-2 it supersedes BS EN ISO9693:2000, which will be withdrawn on publication of part two.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic materials.A list of organizations represe

3、nted on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 598

4、22 7ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPEN

5、NE EUROPISCHE NORM EN ISO 9693-1 February 2012 ICS 11.060.10 Supersedes EN ISO 9693:2000English Version Dentistry - Compatibility testing - Part 1: Metal-ceramic systems (ISO 9693-1:2012) Mdecine bucco-dentaire - Essais de compatibilit - Partie 1: Systmes mtallo-cramiques (ISO 9693-1:2012) Zahnheilk

6、unde - Verbundprfung - Teil 1: Metall-Keramiksysteme (ISO 9693-1:2012) This European Standard was approved by CEN on 14 February 2012. 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 s

7、tandard 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 i

8、n any 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

9、Republic, Denmark, Estonia, Finland, 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. EUROPEAN COMMITTEE FOR STANDARDIZATION COMI

10、T EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9693-1:2012: EBS EN ISO 9693-1:2012EN ISO 9693-1:2012 (E) 3 For

11、eword This document (EN ISO 9693-1:2012) 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 publica

12、tion of an identical text or by endorsement, at the latest by August 2012, and conflicting national standards shall be withdrawn at the latest by August 2012. 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 shal

13、l 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, Bulg

14、aria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, 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 Kingdom. Endorsemen

15、t notice The text of ISO 9693-1:2012 has been approved by CEN as a EN ISO 9693-1:2012 without any modification. BS EN ISO 9693-1:2012ISO 9693-1:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work

16、 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-governmen

17、tal, 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.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main

18、 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. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Atten

19、tion 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.ISO 9693-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic mate

20、rials.This first edition of ISO 9693-1, together with ISO 9693-21), cancels and replaces ISO 9693:1999. It also incorporates the Amendment ISO 9693:1999/Amd 1:2005.ISO 9693 consists of the following parts, under the general title Dentistry Compatibility testing: Part 1: Metal-ceramic systemsThe foll

21、owing parts are under preparation: Part 2: Ceramic-ceramic systems1) Under preparation. ISO 2012 All rights reserved iiiBS EN ISO 9693-1:2012ISO 9693-1:2012(E)IntroductionDental metallic materials and ceramics are suitable for use in the fabrication of metal-ceramic dental restorations.iv ISO 2012 A

22、ll rights reservedBS EN ISO 9693-1:2012Dentistry Compatibility testing Part 1: Metal-ceramic systems1 ScopeThis part of ISO 9693 specifies test methods for determining the compatibility of metallic and ceramic materials used for dental restorations by testing the composite structure.The requirements

23、 given in this part of ISO 9693 are applicable to metallic materials and ceramics when used in combination, and are not applicable to either metallic materials or ceramics when used alone.NOTE Requirements for metallic materials are given in ISO 22674; requirements for ceramic materials are given in

24、 ISO 6872.2 Normative referencesThe 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 1942, Dentistr

25、y VocabularyISO 6872:2008, Dentistry Ceramic materialsISO 22674:2006, Dentistry Metallic materials for fixed and removable restorations and appliances3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 6872 and ISO 22674 apply.4 Requirements4.1

26、BiocompatibilitySpecific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks are not included in this part of ISO 9693, but it is recommended that, for the assessment of such biological risks, reference be made to ISO 10993-1 and ISO 7405.4.2 Proper

27、ties of metal-ceramic systemThe debonding/crack-initiation strength of the metallic material and at least one specified (named) ceramic present shall be greater than 25 MPa. The debonding/crack-initiation strength of the ceramic and at least one specified (named) metallic material present shall be g

28、reater than 25 MPa.Testing shall be carried out in accordance with 6.4.INTERNATIONAL STANDARD ISO 9693-1:2012(E) ISO 2012 All rights reserved 1BS EN ISO 9693-1:2012ISO 9693-1:2012(E)5 Sampling5.1 Metallic materialThe sample shall be adequate for preparing the test specimens in accordance with 6.4.2.

29、 All of the metallic materials procured shall be unused and obtained from the same batch.5.2 CeramicTake a sufficient amount of ceramic (see 6.4.2) to carry out the necessary tests in accordance with this part of ISO 9693. If there is more than one shade of opaque, dentine and enamel ceramics, take

30、equal quantities of each shade.6 Test methods6.1 Linear thermal expansion6.1.1 Ceramic materialsTest methods for ceramic materials shall be in accordance with ISO 6872:2008, 7.4.6.1.2 Metallic materialsTest methods for metallic materials shall be in accordance with ISO 22674:2006, 8.8.6.2 Glass tran

31、sition temperatureTest methods for glass transition temperature shall be in accordance with ISO 6872:2008, 7.5.6.3 Youngs modulusTest methods for Youngs modulus shall be in accordance with ISO 22674:2006, 5.4.4.6.4 Metal-ceramic bond characterization (Schwickerath crack-initiation test)6.4.1 Apparat

32、us6.4.1.1 Flexural-strength testing machine for three-point bending, having a span of 20 mm between supports and which is capable of attaining a cross-head-speed of (1,5 0,5) mm/min. The supports and bending piston shall be rounded to a radius of 1,0 mm.6.4.2 Preparation of test specimensPrepare six

33、 alloy/metal specimens of (25 1) mm (3 0,1) mm (0,5 0,05) mm in accordance with the manufacturers procedure for processing the substructures for metal-ceramic prostheses. Condition the specimens, observing the manufacturers instructions (e.g. cleaning, sandblasting, oxidation).Before applying the ce

34、ramic to the test specimens, calibrate the furnace according to the manufacturers recommendation and test-fire the ceramic material to obtain the appropriate firing grade and surface gloss of both opaque and dentine ceramic. If necessary, adjust the firing temperatures or holding times.In accordance

35、 with the manufacturers instructions, apply opaque ceramic over a length of (8 0,1) mm symmetrically on one 3 mm-wide side of each specimen.Add dentine ceramic 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 s

36、hape.2 ISO 2012 All rights reservedBS EN ISO 9693-1:2012ISO 9693-1:2012(E)If necessary, add additional dentine ceramic 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 metal strip.Submit each

37、specimen to a glaze firing in accordance with the manufacturers instructions.Dimensions in millimetresFigure 1 Test specimen configuration6.4.3 Procedure6.4.3.1 GeneralThe fired specimens are placed in the bending apparatus the distance between the centres of the supports is (20 0,1) mm and the radi

38、us of the bending piston is (1,0 0,1) mm with the ceramic positioned symmetrically on the side opposite the applied load. The force is applied at a constant rate of (1,5 0,5) mm/min and recorded up until failure. The fracture force, Ffail, expressed in newtons, is measured for specimens that fail as

39、 a result of a debonding crack occurring at one end of the ceramic layer. Specimens failing as a result of cracks in the middle of the ceramic layer shall be replaced until six appropriate specimens are obtained.6.4.3.2 Assessment of resultsThe debonding/crack-initiation strength, b, is calculated u

40、sing the following equation:b= k FfailThe coefficient, k, is a function of the thickness of the metal substrate, dM,(0,5 0,05) mm, and the value of Youngs modulus, EM, (determined in accordance with ISO 22674), of the used metallic material. Coefficient k can be read from Figure 2. To read the value

41、 k for a certain thickness dM, first pick the curve for the proper value of EM, then read the value k from the picked curve for the thickness dM.If four specimens out of six (66 %), or more, comply, the system passes the test. If only two, or fewer, comply, the system fails. If three pass, repeat th

42、e test with another six specimens. If five or six of the new specimens pass, the system complies.6.4.4 Alternative procedure6.4.4.1 GeneralThe debonding/crack-initiation strength, b, can also be calculated numerically on the basis of the flow chart shown in Figure 3.6.4.4.2 Assessment of resultsThe

43、metal-ceramic system passes the test if four or more specimens comply with the requirement specified in 4.2.If four specimens out of six (66 %), or more, comply, the system passes the test. If only two, or fewer, comply, the system fails. If three pass, repeat the test with another six specimens. If

44、 five or six of the new specimens pass, the system complies. ISO 2012 All rights reserved 3BS EN ISO 9693-1:2012ISO 9693-1:2012(E)Dimensions in millimetresFigure 2 Diagram to determine the coefficient k as a function of metal substrate thickness, dM, and Youngs modulus, EM, of the metallic material4

45、 ISO 2012 All rights reservedBS EN ISO 9693-1:2012ISO 9693-1:2012(E)Figure 3 Flow chart for numerical calculation of debonding/crack-initiation strength7 Test reportThe test report shall include at least the following information:a) tested materials;b) results obtained from the crack-initiation test

46、, in MPa;c) linear thermal expansion of the tested materials;d) glass transition temperature of the ceramic(s) tested;e) name of the responsible person and the testing laboratory;f) date of the test report and signature of the responsible person. ISO 2012 All rights reserved 5BS EN ISO 9693-1:2012IS

47、O 9693-1:2012(E)Bibliography1 ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry2 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process3 ISO 6892-1:20091), Metallic materials Tensile testing Part 1:

48、Method of test at room temperature1) Cancels and replaces ISO 6892:1998.6 ISO 2012 All rights reservedBS EN ISO 9693-1:2012This page deliberately left blankThis page deliberately left blankBSI is the independent national body responsible for preparing British Standards and other standards-related pu

49、blications, information and services. It presents the UK view on standards in Europe and at the international level. BSI is incorporated by Royal Charter. British Standards and other standardisation products are published by BSI Standards Limited.British Standards Institution (BSI)raising standards worldwideBSI389 Chiswick High Road London W4 4AL UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 Standards and PASs are periodically