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1、BRITISH STANDARD BS EN ISO 9693:1995 Specification for Dental ceramic fused to metal restorative materials The European Standard EN ISO 9693:1994 has the status of a British Standard UDC 616.314.089.28:615.464/.465 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncon
2、trolled Copy, (c) BSI BS EN ISO 9693:1995 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 April 1995 BSI 11-1999 The following BSI references relate to the
3、 work on this standard: Committee reference HCC/51 Draft for comment 89/53902 DC ISBN 0 580 23592 0 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee HCC/51, Prosthodontic and orthodontic materials, upon which the following
4、 bodies were represented: Association of Dental Hospitals of the United Kingdom British Ceramic Research Ltd. British Dental Association British Dental Trade Association British Institute of Surgical Technologists British Orthodontic Society British Society for Restorative Dentistry British Society
5、for the Study of Prosthetic Dentistry British Society of Periodontology Dental Laboratories Association Limited Dental Materials Panel Department of Health Gypsum Products Development Association Institute of Materials Institute of Physics Ministry of Defence Orthodontic Technicians Association Roya
6、l Society of Medicine Society of University Dental Instructors Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 9693:1995 BSI 11-1999i Contents Page Committees responsibleInsi
7、de front cover National forewordii Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Requirements4 5Sampling4 6Test methods5 7Manufacturers instructions7 8Packaging and marking7 Figure 1 Test specimen with cylindrical ends5 Figure 2 Test specimen with threaded ends5 Figure 3 Test
8、 specimen with suggested sprues and sprue button5 Table 1 Mechanical properties of alloys4 Table 2 Properties of ceramics4 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 9693:1995 ii BSI 11-1999
9、 National foreword This British Standard has been prepared by Technical Committee HCC/51 and is the English language version of EN ISO 9693 Dental ceramic fused to metal restorative materials published by the European Committee for Standardization (CEN). It is identical with ISO 9693:1991 published
10、by the International Organization for Standardization (ISO). A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from
11、 legal obligations. Cross-references Publication referred toCorresponding British Standard ISO 3696:1987BS 3978:1987 Specification for water for laboratory use Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, pages 2 to 8, an insid
12、e back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c)
13、 BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9693 October 1994 UDC 616.314-089.28:615.464/.465 Descriptors: Dentistry, dental materials, alloys, ceramics, specifications, tests, packaging, marking English version Dental ceramic fused to metal restorative materials (ISO 9693:1991) Pr
14、oduits pour restaurations dentaires mtallo-cramiques (ISO 9693:1991) Metall-Keramik-Systeme fr zahnrztliche Restaurationen (ISO 9693:1991) This European Standard was approved by CEN on 1994-10-14. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition
15、s 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 application to the Central Secretariat or to any CEN member. This European Standard exists in three offi
16、cial 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria,
17、Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de
18、Stassart 36, B-1050 Brussels 1994 Copyright reserved to CEN members Ref. No. EN ISO 9693:1994 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9693:1994 BSI 11-1999 2 Foreword The European Standard has been taken over by Technical Co
19、mmittee CEN/TC 55, Dentistry from the work of ISO/TC 106, Dentistry of the International Standardization Organization (ISO). The text was submitted to the Primary Questionaire Procedure (PQ) and approved as a European Standard. This European Standard shall be given the status of a national standard,
20、 either by publication of an identical text or by endorsement, at the latest by April 1995, and conflicting national standards shall be withdrawn at the latest by April 1995. According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Aus
21、tria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9693:1994 BSI 11
22、-19993 Introduction Dental casting alloys and ceramics are suitable for use in fabrication of metal-ceramic dental restorations. Specific qualitative and quantitative requirements of freedom from biological hazard are not included in this International Standard but it is recommended that, in assessi
23、ng possible biological or toxicological hazards, reference should be made to ISO/TR 7405:1984, Biological evaluation of dental materials, or any more recent edition. It is intended to replace the metallo-ceramic bond characterization test with a clinically relevant bond test as soon as it is availab
24、le in a future revision of this Standard. Requirements and test methods for tarnish and corrosion resistance for the components and for the metallo-ceramic system will also be included in the future as soon as they are available. 1 Scope This International Standard specifies requirements and test me
25、thods for dental casting alloys and ceramics suitable for use in the fabrication of metallo-ceramic dental restorations together with requirements and test methods for the composite structure. The requirements of this International Standard apply to the alloys and ceramics when used in combination a
26、nd compliance may not be claimed for either alloys or for ceramics alone. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All
27、standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
28、 ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 6872:1984, Dental ceramic. ISO 6892:1984, Metallic materials Tensile testing. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 alloy casting alloy suitable for u
29、se as the substructure of a metallo-ceramic restoration 3.2 alloy coatings and bonding agents substances (e.g. electroplated layers, or agents containing ceramic and/or alloy particles) which, when applied to the metal substructure and fired under appropriate time-temperature conditions improve aest
30、hetics and may enhance the adherence of ceramic to the coated alloy surface 3.3 alloy conditioning process of conditioning the alloy substructure, either by heat treatment or by other means, designed to enhance the bonding of ceramic to metal 3.4 heating rate rate of increase in temperature in degre
31、es Celsius per minute 3.5 firing schedule temperature-time cycle stating the initial temperature, the time period at the initial temperature, if any, the heating rate, the final temperature, the time period at the final temperature, if any, and in the case of vacuum firing the temperature of vacuum
32、application and the point of release 3.6 opaque bonding dental ceramic ceramic product that, when mixed with distilled water or appropriate modelling liquid, applied to an alloy, and treated according to the firing schedule for the opaque ceramic, will bond to the alloy surface to form a layer that
33、visibly masks the metallic colour 3.7 dental dentine ceramic slightly translucent, pigmented dental ceramic used to give the overall shape and basic colour of the ceramic part of a ceramic fused to metal restoration or prosthesis 3.8 dental enamel ceramic translucent, lightly-pigmented dental cerami
34、c used on a base (or core) of dentine ceramic to simulate the natural tooth enamel Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9693:1994 4 BSI 11-1999 4 Requirements 4.1 Chemical composition 4.1.1 Alloy The percentage of each of t
35、he constituents of the alloy, in excess of 2 % (m/m), shall be within 0,5 % (m/m) (noble metal alloys) and within 1 % (m/m) (base metal alloys) of the values stated on the package label or insert see 8.2.2 c). The percentage of nickel, beryllium and cadmium shall not be greater than the amounts indi
36、cated on the package label or insert see 8.2.2 d) when analysed according to 6.1.1. Testing shall be carried out in accordance with 6.1.1. 4.1.2 Ceramic The ceramic shall meet the requirements of ISO 6872:1984, clauses 5.1 and 5.2 (except for the note in 5.2.2). Fluorescing agents which will increas
37、e the radioactivity of the ceramic shall not be added. 4.2 Biocompatibility See the Introduction for guidance on biocompatibility. 4.3 Properties 4.3.1 Alloy The mechanical properties of the alloys shall comply with the requirements of Table 1. The solidus and liquidus temperatures of the alloys sha
38、ll be within 10 C of the values stated on the package label or insert see 8.2.2 g). The coefficient of linear thermal expansion of the alloys shall be within 0,2 106 K1 of the value stated on the package label or insert see 8.2.2 h). The density of the alloy as supplied by the manufacturer shall be
39、within 0,5 g/cm3 of the value stated on the package label or insert see 8.2.2 i). Testing shall be carried out in accordance with 6.1.2, 6.1.3 and 6.3.1 respectively. Standard test procedures shall be used for determining the density. Table 1 Mechanical properties of alloys 4.3.2 Ceramic The flexura
40、l strength and the chemical solubility of the fired ceramics shall meet the requirements of Table 2. The porosity of the fired ceramic shall meet the following requirement: there shall be not more than 16 pores of a diameter greater than 30 4m in any area of 1 mm diameter. The coefficient of linear
41、thermal expansion of the ceramics shall be within 0,5 106 K1 of the value stated by the manufacturer see 8.2.3 d). The glass transition temperature of the ceramics shall be within 10 C of the value stated by the manufacturer see 8.2.3 e). Testing shall be carried out in accordance with 6.2.1, 6.3.1
42、and 6.3.2 respectively. Table 2 Properties of ceramics 4.3.3 Metallo-ceramic system The alloy and a specified (named) ceramic shall pass the test when assessed according to 6.3.3.4. The ceramic and a specified (named) alloy shall pass the test when assessed according to 6.3.3.4. Testing shall be car
43、ried out in accordance with 6.3.3. NOTE 1The measured values for coefficients of linear thermal expansion are compared with the manufacturers values as a means of quality control, but the values do not themselves provide an assurance that the alloy and ceramic are compatible. 5 Sampling 5.1 Alloy Al
44、l of the alloy procured for testing in accordance with this International Standard shall be unused and obtained from the same batch. 5.2 Ceramic At least 50 g of one shade of each of opaque, dentine, enamel ceramics and the appropriate modelling liquids shall be obtained for testing in accordance wi
45、th this International Standard. Proof stress of non-proportional elongation, Rp0,2 Percentage elongation after fracture MPa min.min. 2502 Flexural strength Chemical solubility, loss in mass MPa min. % max. Opaque Dentine Enamel 50 50 50 0,05 0,05 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 1
46、5 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9693:1994 BSI 11-19995 6 Test methods 6.1 Alloy 6.1.1 Chemical composition Standard analytical procedures shall be used for determining the composition. 6.1.2 Mechanical properties 6.1.2.1 Preparation of test specimens Prepare six specimen
47、s as shown in Figure 1 or Figure 2 by the “lost wax” process of investment casting generally employed in a dental laboratory. It is suggested that the specimens should be cast using the sprue system shown in Figure 3, but other sprueing is also acceptable. Follow the manufacturers instructions for p
48、rocessing the alloy and for using the necessary aids and casting equipment. After having carefully separated sprues and any nodules, fins, etc., clean the cast specimens. Discard any specimens with visible shrinkage defects or porosities. Place the specimens on a tray in a furnace at 950 C for 10 mi
49、n and then remove them from the furnace, place them on a refractory plate, and allow them to cool. Use these specimens for the tests in 6.1.2.2 and 6.1.2.3. 6.1.2.2 Proof stress of non-proportional elongation Determine the proof stress of non-proportional elongation in accordance with ISO 6892 on test specimens, cast and conditioned in accordance with 6.1.2.1. Load the test specimens in a tensile tester at a cross-head speed of 1,5 mm/min 0,5 mm/min up to the fracture point of the specimens. Determine the values fro