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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 9693:2000 The E
2、uropean Standard EN ISO 9693:2000 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Metal-ceramic dental restorative systems Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c)
3、BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 November 2000 BSI 11-2000 ISBN 0 580 36214 0 BS EN ISO 9693:2000 Amendments issued since public
4、ation Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 9693:2000. It is identical with ISO 9693:1999. It supersedes BS EN ISO 9693:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/5
5、1, Prosthodontic materials, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European
6、developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Further Information Users of this standard are informed that the UK submitted a vote of disapproval at the final voting stage of this EN ISO for the followin
7、g reason: Clause 4.1.1 does not specify a permissable upper limit for beryllium content, only that the beryllium content shall not exceed that stated by the manufacturer. This requirement is not considered stringent enough to adequately protect patients. Cross-references Attention is drawn to the fa
8、ct that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue un
9、der the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct appl
10、ication. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 14, the a
11、nnex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9693 Sep
12、tember 2000 ICS 11.060.00Supersedes EN ISO 9693:1994 English version Metal-ceramic dental restorative systems (ISO 9693:1999) Systmes pour restaurations dentaires mtallo-cramiques (ISO 9693:1999) Dentale restaurative Metallkeramiksysteme (ISO 9693:1999) This European Standard was approved by CEN on
13、18 June 2000. 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 concerning such national standards may be
14、 obtained on application to the 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 into its own language and notified to the Managemen
15、t Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EURO
16、PEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9693:2000 E Licensed Co
17、py: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Dentistry“ of the International Organization for Standardization (ISO) has been taken over as an European Standard by T
18、echnical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard replaces EN ISO 9693:1994. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2001, and
19、 conflicting national standards shall be withdrawn at the latest March 2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, G
20、ermany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 9693:1999 has been approved by CEN as a European Standard without any modification. NOTE: Normative ref
21、erences to International Standards are listed in annex ZA (normative). EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 9693:1999(E) INTERNATIONAL STANDARD ISO 9693 Second edition 1999-12-15 Metal-ceramic
22、 dental restorative systems Systmes pour restaurations dentaires mtallo-cramiques EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii? EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00
23、 2006, Uncontrolled Copy, (c) BSI ?iii Contents?Page Foreword.iv Introduction.v 1?Scope 1 2?Normative references1 3?Terms and definitions .1 4?Requirements.2 5?Sampling.4 6?Test methods4 7?Information and instructions10 8?Packaging, marking and labelling11 Bibliography14 EN ISO 9693:2000 Licensed Co
24、py: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv? Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally
25、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-governmental, in liaison with ISO, also take part in the wo
26、rk. 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 3. Draft International Standards adopted by the technical c
27、ommittees 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. International Standard ISO 9693 was prepared by Technical Committee ISO/TC 106,Dentistry, Subcommittee SC 2,Prosthodontic materia
28、ls. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. This second edition cancels and replaces the first edition (ISO 9693:1991), which h
29、as been technically revised. Significant differences between this second edition and the first edition are: ?the scope includes metallic materials (not only alloys) processed by casting or machining; ?a requirement (4.3.3) and a test (6.3.3) on the debonding/crack-initiation strength for the metal-c
30、eramic system have been added, replacing the previous requirement and test related to metal-ceramic bond characterization. EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ?v Introduction Dental metallic materials and ceramic
31、s are suitable for use in fabrication of metal-ceramic dental restorations. Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this International Standard, but it is recommended that, in assessing possible biological hazards, reference be made
32、to ISO 10993-1 and ISO 7405. Requirements and test methods for tarnish and corrosion resistance for the components and for the metal-ceramic system will be included in the future when they are available. EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006,
33、 Uncontrolled Copy, (c) BSI EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ?1 Metal-ceramic dental restorative systems 1?Scope This International Standard specifies requirements and test methods for dental metallic material
34、s processed by casting or machining, and for ceramics suitable for use in the fabrication of metal-ceramic dental restorations, together with requirements and test methods for the composite structure. The requirements of this International Standard apply to the metallic materials and ceramics when u
35、sed in combination, and compliance may not be claimed for either metallic materials or for ceramics alone. 2?Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, su
36、bsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references,
37、the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 3696:1987,Water for analytical laboratory use Specification and test methods. ISO 6872:1995,Dental ceramic. ISO 6892:1998,Metallic materials Ten
38、sile testing at ambient temperature. ASTM B 265-95,Standard specification for titanium and titanium alloy strip, sheet and plate. ASTM B 348-93,Standard specification for titanium and titanium alloy bars and billets. 3?Terms and definitions For the purposes of this International Standard, the follow
39、ing terms and definitions apply. 3.1 alloy/metal conditioning process of treating the metal substructure to enhance the bonding of ceramic to metal 3.2 coating agent bonding agent substance which, when applied to the metal substructure and fired under appropriate time-temperature conditions, improve
40、s aesthetics and may enhance the adherence of ceramic to the coated metal surface NOTE?Examples of such substances are electroplated layers, or agents containing ceramic and/or alloy particles. EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:26:40 GMT+00:00 2006, Uncontrol
41、led Copy, (c) BSI 2? 3.3 dental dentine ceramic slightly translucent, pigmented dental ceramic used to impart the overall shape and basic colour of the ceramic part of a metal-ceramic restoration or prosthesis 3.4 dental enamel ceramic translucent, lightly pigmented dental ceramic, used on a core or
42、 a base of dentine ceramic to simulate the natural tooth enamel 3.5 firing schedule temperature-time cycle stating the initial temperature, the time period (if any) at the initial temperature, the heating rate, the final temperature, the time period (if any) at the final temperature and, in the case
43、 of vacuum firing, the temperature of vacuum application and the point of release 3.6 heating rate rate of temperature increase NOTE?It is expressed in degrees Celsius per minute. 3.7 metallic material alloy or metal suitable for use as the substructure of a metal-ceramic restoration 3.8 opaque bond
44、ing dental ceramic ceramic product that, when mixed with distilled water or other appropriate liquid, applied to a dental metallic material and treated according to the firing schedule for the opaque ceramic, will bond to the metal surface to form a layer that visibly masks the metallic colour 4?Req
45、uirements 4.1? Chemical composition 4.1.1?Metallic material For noble metal alloys, the percentage of each alloy constituent shall not deviate from the value stated on the package label or insert by more than 0,5 % (mass fraction) see 8.2.2 c). For base metal alloys, the content of constituents pres
46、ent in excess of 20 % (mass fraction) shall not deviate from the value stated on the package label or insert by more than 2 % (mass fraction). The content of constituents present in excess of 2 % (mass fraction) but not in excess of 20 % (mass fraction) shall not deviate from the value stated on the
47、 package label or insert by more than 1 % (mass fraction) see 8.2.2 c). The percentage content of nickel, beryllium and cadmium shall not be greater than the amounts indicated on the package label or insert see 8.2.2 d). Testing shall be carried out in accordance with 6.1.1. For unalloyed titanium,
48、the grade according to ASTM Designation B 265-95 (strip, sheet and plate) or B 348-93 (bars and billets) shall be certified, i.e. standard specification data apply. A certificate from the supplier of the titanium shall be required. EN ISO 9693:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
49、 15 13:26:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ?3 4.1.2?Ceramic The ceramic shall meet the requirements of ISO 6872:1995/Amd.1:1997, 5.1 and 5.2. Test in accordance with ISO 6872:1995/Amd. 1:1997. 4.2? Biocompatibility See the Introduction for guidance on biocompatibility. 4.3? Properties 4.3.1?Metallic material The mechanical properties of the metallic materials as processed shall comply with the requirements of Table 1. Table 1 Mechanical properties of metallic materials Proof stress of non- proportional elongation, Rp0,2 MPa min. Percentage
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