EN ISO 9693-2000 4375 Metal-Ceramic Dental Restorative Systems《牙科金属烤瓷修复系统 ISO 9693-1999》.pdf

1、 STD-BSI BS EN IS0 9693-ENGL 2000 Lb24hb7 0880070 942 BRITISH STANDARD Metal-ceramic dental restorative systems The European Standard EN IS0 96932000 has the status of a British Standard ICs 11.060.10 35 EN IS0 )693:2000 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITIED BY COPYRIGHT LAW Copyrigh

2、t European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STDmBSI BS EN IS0 9b93-ENGL 2000 I Lb24669 0880073 889 was published under the authority of the Standards Amd. No. Date Committee and come

3、s into effect on 15 November 2000 O BSI 11-2000 ISBN O 580 36214 O BS EN IS0 9693:2000 Comments National foreword This British Standard is the official English language version of EN IS0 9693:2. It is identicd with IS0 96931999. It supersedes BS EN IS0 96931995 which is withdrawn. The UK participati

4、on in its preparation was entrusted to Technical Committee CH1, Prosthodontic materials, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible internationa/European committee any enquiries on the interpretation, or proposals for change, and keep the UK

5、 interests informed; - monitor related inte-onal and European 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 disappr

6、oval at the nnal voting stage of this EN IS0 for the following 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 ma.nufacturer. This requirement is not considered stringent enough to adequately p

7、rotect patients. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative references to intemational publications with their corresponding European publications. The British Standards which implement these international or Europea

8、n publicalions may be found in the BSI Standards Catalogue under the section entitled “Intedonal Standards Correspondence Index“, or by using the “Find“ facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include ail the necessary provisions of a contract. User

9、s of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permi

10、tted without license from IHS-,-,- STD-BSI BS EN IS0 9693-ENGL 2000 m Lb24bb9 0880072 7L5 m EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IS0 9693 September 2000 ICs 11.060.00 Supersedes EN IS0 9693:1994 English version Metal-ceramic dental restorative systems (IS0 9693: 1999) Systmes pour re

11、staurations dentaires mtallo-cramiques (IS0 96931999) Dentale restaurative Metallkeramiksysteme (IS0 9693:1999) This European Standard was approved by CEN on 18 June 2000. CEN members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this European

12、 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 Management Centre or to any CEN member. This European Standard exists in three official versions (English, Fren

13、ch, 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denma

14、rk, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 8-1050 B

15、russels 8 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN IS0 9693:2000 E Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without lic

16、ense from IHS-,-,- STDmBSI BS EN IS0 9b93-ENGL 2000 E Lb24bb7 0880073 b5L = EN IS0 9693:2000 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 Tech

17、nical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard replaces EN IS0 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 co

18、nflicting national standards shall be withdrawn at the latest March 2001. According to the CENICENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germ

19、any, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard IS0 9693:1999 has been approved by CEN as a European Standard without any modification. NOTE: Normative refere

20、nces to International Standards are listed in annex ZA (normative). Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STDmBSI BS EN IS0 7b73-ENGL 2000 lb24bb7 0880074 578 EN IS0 96

21、93:2000 INTERNATIONAL STANDARD IS0 Second edition 1999-12-15 Metal-ceramic dental restorative systems Systmes pour restaurations dentaires mtallo-cramiques Reference number IS0 9693: 1 999( E) Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo rep

22、roduction or networking permitted without license from IHS-,-,- STD.BS1 BS EN IS0 9b93-ENGL 2000 m Lb24bb9 0880075 424 m EN IS0 9693:2000 Contents Page Foreword . iv Introduction . v 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 Requirements . 2 5 Sampling . 4 6 Test methods 4 7 I

23、nformation and instructions 10 8 Bibliography 14 Packaging, marking and labelling 11 Previous page is blank . iii Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- STD-BSI BS EN I

24、S0 qbq3-ENGL 2000 Lb24bb9 OB8007b 3b0 W EN IS0 9693:2000 Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committee

25、s. 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 work. IS0 collaborates closely with the Inter

26、national Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISOAEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodie

27、s for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 9693 was prepared by Technical Committee ISOTTC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. Attention is drawn to the possibility

28、that some of the elements of this International Standard may be the subject of patent rights. IS0 shall not be held responsible for identifying any or all such patent rights. This second edition cancels and replaces the first edition (IS0 9693:1991), which has been technically revised. Significant d

29、ifferences 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 debondingkrack-initiation strength for the metal-ceramic system have been added, replacing

30、the previous requirement and test related to metal-ceramic bond characterization. iv Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- STD=BSI BS EN IS0 9693-ENGL 2000 M 1624669 0

31、880077 2T7 = EN IS0 9693:2000 Introduction Dental metallic materials and ceramics 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 i

32、s recommended that, in assessing possible biological hazards, reference be made to IS0 10993-1 and IS0 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. V Copyright Euro

33、pean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STD.BSI BS EN IS0 b3-ENGL 2000 Lb24669 0880078 133 EN IS0 9693:ZOOO Metal-ceramic dental restorative systems 1 Scope This International Standard

34、 specifies requirements and test methods for dental metallic materials 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 Inter

35、national Standard apply to the metallic materials and ceramics when used 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, constitut

36、e provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, patties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions

37、 of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IS0 and IEC maintain registers of currently valid International Standards. IS0 3696:1987, Water for analytical laboratory use - Specification and test met

38、hods. IS0 6872: 1 995, Dental ceramic. IS0 6892:1998, Metallic materials - Tensile tesfing 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 T

39、erms and definitions For the purposes of this International Standard, the following 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 met

40、al substructure and fired under appropriate time-temperature conditions, improves 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 andor alloy particles. 1 Copyright European Commit

41、tee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STD-BSI BS EN IS0 9b93-ENGL 2000 U 11b24bb9 0880079 07T = EN IS0 9693:2000 3.3 dental dentine ceramic slightly translucent, pigmented dental ceramic used t

42、o 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 a base of dentine ceramic to simulate the natural tooth enamel 3.5 firing schedule temperature-time

43、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 of vacuum firing, the temperature of vacuum application and the point of release 3.6 heating rate ra

44、te 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 bonding dental ceramic ceramic product that, when mixed with distilled water or other appropriate liquid,

45、 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 Requirements 4.1 Chemical composition 4.1.1 Metallic material For noble metal alloys, the percentage of

46、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 present in excess of 20 % (mass fraction) shall not deviate from the value stated on the package label or

47、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 package label or insert by more than 1 % (mass fraction) see 8.2.2 c). The percentage content of nick

48、el, 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, the grade according to ASTM Designation B 265-95 (strip, sheet and plate) or B 348-93 (bars and billet

49、s) shall be certified, .e. standard specification data apply. A certificate from the supplier of the titanium shall be required. 2 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STD-BSI BS EN IS0 qbq3-ENGL 2000 I Lh24bh9 OB80080 891 = EN IS0 969