BS EN ISO 9333-2006 Dentistry - Brazing materials《牙科 上光材料》.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58The European Standard EN ISO 9333:2006 has the status of a British StandardICS 11.060.10Dentistry B

2、razing materialsBRITISH STANDARDBS EN ISO 9333:2006BS EN ISO 9333:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2006 BSI 2006ISBN 0 580 49735 6Amendments issued since publicationAmd. No. Date Commentscontract. Users are resp

3、onsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 9333:2006. It supersedes BS EN 29333:1992 which is withdrawn.The UK participation in

4、 its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodontic materials.A list of organizations represented on CH/106/2 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a EUROPE

5、AN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 9333July 2006ICS 11.060.10 Supersedes EN 29333:1991 English VersionDentistry - Brazing materials (ISO 9333:2006)Art dentaire - Produits pour brasage (ISO 9333:2006) Zahnheilkunde - Hartlote (ISO 9333:2006)This European Standard was approved by CEN on 1

6、4 July 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obt

7、ained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secre

8、tariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portug

9、al, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means rese

10、rvedworldwide for CEN national Members.Ref. No. EN ISO 9333:2006: EForeword This document (EN ISO 9333:2006) 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 Standar

11、d shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2007, and conflicting national standards shall be withdrawn at the latest by January 2007. This document supersedes EN 29333:1991. According to the CEN/CENELEC I

12、nternal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne

13、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 9333:2006 has been approved by CEN as EN ISO 9333:2006 without any modifications. EN ISO 9333:2006INTERNATIONALSTANDARDISO9333Second edition2006-07-15Re

14、ference numberISO 9333:2006(E)Dentistry Brazing materialsArt dentaire Produits pour brasageEN ISO 9333:2006iiiiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The work of preparing International Standards is

15、 normally carried out through ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in

16、 the work. ISO collaborates closely with the InternationalElectrotechnical 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 task of technical committees is to prepare

17、International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of

18、the elements of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 9333 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodonticmaterials.This second edition cancels and replaces the

19、 first edition (ISO 9333:1990), subclauses 4.1 and 4.4 of whichhave been technically revised:a) in 4.1 by the introduction of upper limits for cadmium, beryllium and lead;b) in 4.4 by a reduction in the mechanical strength of a brazed joint;c) further, the requirement for flow temperature has been c

20、ancelled.EN ISO 9333:2006blank1Dentistry Brazing materials1ScopeThis International Standard specifies requirements and test methods for brazing materials suitable for use inmetallic restorations.2 Normative referencesThe following referenced documents are indispensable for the application of this do

21、cument. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 7405, Dentistry

22、Preclinical evaluation of biocompatibility of medical devices used in dentistry Testmethods for dental materialsISO 10271:2001, Dental metallic materials Corrosion test methodsISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing3 Terms and definitionsFor the purposes

23、of this document, the terms and definitions given in ISO 1942 and the following apply.3.1 brazing materialalloy suitable for use as a filler material in operations in which dental alloy parts are joined by brazing to formdental appliances and restorations3.2 noble metalgold, platinum, palladium, rut

24、henium, iridium, osmium and rhodium3.3 base metalall metallic elements with the exception of noble metals and silverEN ISO 9333:200624 Requirements4.1 Chemical composition4.1.1 Reported compositionFor all elements that are present in excess of (mass fraction), the percentage by mass of each of theco

25、nstituent elements shall be declared by the manufacturer and shall be reported as instructed in 8 c) to aprecision of (mass fraction). Any element that is present in a concentration in excess of (massfraction), but not in excess of (mass fraction), shall be identified as instructed in 8 c) either by

26、 name orsymbol.4.1.2 Permitted deviation from the reported compositionFor silver-based or noble-metal-based brazing materials the percentage of each of the constituents shall notdeviate by more than (mass fraction) from the values stated in the manufacturers or distributorsinstructions for use see 8

27、 c).For base-metal-based brazing materials, all elements present with more than (mass fraction) shall notdeviate from the value stated in the manufacturers or distributors instructions for use by more than (massfraction). Those present in excess of (mass fraction) but not in excess of (mass fraction

28、) shall notdeviate from the value stated in the manufacturers or distributors instructions for use by more than (massfraction) see 8 c).4.1.3 Hazardous elements4.1.3.1 Recognised hazardous elementsFor the purposes of this document the elements nickel, cadmium, beryllium and lead are designated to be

29、hazardous elements.4.1.3.2 Permitted limits for hazardous elementsThe brazing material shall not contain more than (mass fraction) of cadmium or beryllium or lead. If thebrazing material contains more than (mass fraction) of nickel, the percentage shall not exceed theamount indicated on the package

30、see 9.2 e) or insert see 8 d).4.2 BiocompatibilitySpecific qualitative and quantitative requirements for freedom from biological hazard are not included in thisInternational Standard but it is recommended that, in assessing possible biological hazards, reference shouldbe made to ISO 10993-1 and ISO

31、7405.4.3 Corrosion resistanceA comparison of the surface of the tested specimens with that of the untested specimens shall not reveal anyvisible evidence that a chemical reaction has occurred.Testing shall be carried out in accordance with 7.3.1,0 %0,1 % 0,1 %1,0 %0,5 %20 %2%1% 20 %1%0,02 %0,1 %EN I

32、SO 9333:200634.4 Mechanical strength (tensile strength) of brazed jointThe tensile strength shall exceed . If the proof strength of either one or both of the metallicmaterials to be joined by the brazing material is below , the tensile strength shall exceed the lower ofthe two.Testing shall be carri

33、ed out in accordance with 7.4.4.5 Melting rangeThe solidus temperature and the liquidus temperature of the brazing material shall be within of thevalues given in the manufacturers instructions see 8 e).Testing shall be carried out in accordance with 7.5.5 SamplingThe amount of test material shall be

34、 sufficient to prepare the specimens required in 6.2 and 6.3, includingprovision for a second set for tensile testing.6 Preparation of test specimens6.1 GeneralThe test specimens consist of the recommended metallic materials joined with the brazing material according tothe manufacturers instructions

35、. Prepare the test specimens by the “lost wax process” of investment casting.Methods other than casting may be recommended by the manufacturer for the metallic material to be testedwith brazing materials. Use such a method, if recommended by the manufacturer. Follow the manufacturersinstructions rel

36、ating to the processing of the metallic material(s) and the brazing material including necessaryaids, casting and brazing equipment as given in 8 f) and 8 g).6.2 Specimens for corrosion testingPrepare four pieces of dimensions approximately and clean the surfaces. Cut thesamples in half . Use two ha

37、lves of the pieces for brazing. If two different metallicmaterials are to be brazed, use one of each for the two halves. Set the gap between the cut pieces at. Use the recommended flux and follow the manufacturers instructions on brazing. Followingbrazing remove at least from all surfaces of the sam

38、ples using standard metallographic proceduresending with wet silicon carbide paper of grade P 1200 in accordance with ISO 6344-1. Use the same grindingpaper solely for the preparation of specimens of the same composition.6.3 Specimens for tensile testingPrepare a set of six specimens of the metallic

39、 material(s) to be brazed, which comply with either Figure 1 orFigure 2. Replace specimens that have visible shrinkage, defects or porosities. Cut the specimens of the set atright angles to its long axis at the midpoint of the gauge length using a fine saw. Remove rough edges. Grind thecut surface s

40、mooth, plane and perpendicular to the axis of the test specimen. Support the two halves of thespecimens and align them in an investment or a rigid jig. If two different metallic materials are to be brazed, useone of each for the two halves. Set the gap between the cut pieces at . Use the recommended

41、flux and follow the manufacturers instructions on brazing.After brazing, ensure that the diameter of each tensile specimen is within the tolerances given in Figure 1 orFigure 2, and does not show visual evidence of radial run-out when rotated.250 MPa 0,2 %250 MPa20C10 mm 10 mm 1mm(5 mm 10 mm 1 mm)(0

42、,2 0,1) mm0,1 mm(0,2 0,1) mmEN ISO 9333:20064If the proof strength of non-proportional elongation of the dental metallic material for which the brazing materialis recommended is less than , prepare an additional set of six specimens of the metallic material to bebrazed to determine its proof strengt

43、h.7Testing7.1 Visual inspection7.1.1 SpecimensWithout the aid of magnification, inspect the surface of specimens to be tested for visible defects. Replace anytest specimens that have defects.7.1.2 Information and instructions, packaging and labellingVisually inspect to check that the requirements sp

44、ecified in Clauses 8 and 9 have been met.Dimensions in millimetresFigure 1 Test specimen with conical shouldersDimensions in millimetresFigure 2 Test specimen with radial shoulders250 MPa0,2 %EN ISO 9333:200657.2 Chemical compositionDetermine the composition using analytical procedures with sensitiv

45、ities appropriate to the concentration ofeach element and its permitted deviation from the stated value or permitted limit.7.3 Corrosion testingPerform the static immersion test with four of the brazed specimens (6.2), using the test solution and testmethod in accordance with ISO 10271:2001, 4.1.Aft

46、er the test, inspect the brazed gap of the specimens under a microscope at a magnification of .7.4 Tensile testing7.4.1 Apparatus7.4.1.1 Micrometer, accurate to with a measuring capacity of .7.4.1.2 Universal mechanical testing machine, with a capacity in excess of for both frame and loadcell, and t

47、hat operates at a cross-head speed up to .Select grips appropriate for the specimens to be used. Conduct tensile testing with a system that has a springconstant (defined as the ratio of the load applied to its elastic deflection) very significantly greater than the load-extension ratio of the specim

48、en under test. (The system comprises the testing machine frame, load cell andattachments). Record the specimen extension free from the machine deflection.7.4.2 Test procedureDetermine the tensile strength on a set of six brazed specimens, produced in accordance with 6.3.If applicable, determine the

49、proof strength of non-proportional elongation for the metallic materialintended for brazing. Use a set of six specimens.Measure the diameter of each specimen to an accuracy of using the micrometer (7.4.1.1).Conduct the test at ambient room temperature.Load the specimens in tension into the universal mechanical testing machine (7.4.1.2) at a cross-head speed ofup to the fracture point of the specimens. Record the force and elongation continuously.Examine the fractured specimen to dete