BS EN ISO 28319-2010 Dentistry - Laser welding《牙科学 激光焊接》.pdf

1、BS EN ISO28319:2010ICS 11.060.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Laserwelding (ISO28319:2010)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN 978 0 580 59602 5

2、Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 28319:2010National forewordThis British Standard is the UK implementation of EN ISO 28319:2010.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic materials.A list of organizations re

3、presented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN ST

4、ANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 28319 May 2010 ICS 11.060.10 English Version Dentistry - Laser welding (ISO 28319:2010) Mdecine bucco-dentaire - Soudage par laser (ISO 28319:2010) Zahnheilkunde - Laserschweien (ISO 28319:2010) This European Standard was approved by CEN on 12 May 2010.

5、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 obtained on a

6、pplication to the CEN 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 CEN Management Cent

7、re has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norw

8、ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form

9、and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28319:2010: EBS EN ISO 28319:2010EN ISO 28319:2010 (E) 3 Foreword This document (EN ISO 28319:2010) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Denti

10、stry” the secretariat of which is held by DIN. 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 November 2010, and conflicting national standards shall be withdrawn at the latest by November 2010.

11、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 shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organization

12、s of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

13、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 28319:2010 has been approved by CEN as a EN ISO 28319:2010 without any modification. BS EN ISO 28319:2010ISO 28319:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv 1 Sc

14、ope1 2 Normative references1 3 Terms and definitions .1 4 Requirements.2 4.1 Chemical composition 2 4.2 Biocompatibility.2 4.3 Mechanical strength of laser-welded joint (tensile strength) .2 4.4 Corrosion resistance.3 5 Sampling.3 6 Preparation of specimens.3 6.1 General .3 6.2 Specimens for tensile

15、 testing 4 6.3 Specimens for corrosion testing .5 7 Testing5 7.1 Visual inspection .5 7.2 Chemical composition 5 7.3 Tensile testing .5 7.4 Corrosion testing by static immersion6 8 Information and instructions7 9 Marking and labelling7 9.1 Marking.7 9.2 Labelling.7 10 Test report8 Annex A (informati

16、ve) Quality assurance of laser welding 9 Bibliography13 BS EN ISO 28319:2010ISO 28319:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internation

17、al 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-governmental, in liaison with ISO,

18、 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 task of technical comm

19、ittees 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. Attention is drawn to the p

20、ossibility 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 28319 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. BS EN ISO 28319

21、:2010INTERNATIONAL STANDARD ISO 28319:2010(E) ISO 2010 All rights reserved 1Dentistry Laser welding 1 Scope This International Standard specifies requirements and test methods for laser welding, in the dental laboratory, of materials suitable for use in metallic restorations and appliances. 2 Normat

22、ive references The 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, Dentistry Vocabulary ISO

23、 3585, Borosilicate glass 3.3 Properties ISO 3696, Water for analytical laboratory use Specification and test methods ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 10271, Dental metallic materials Corrosion test methods ISO 22674:2006, Dentistry Metallic m

24、aterials for fixed and removable dental restorations and appliances 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942, ISO 22674 and the following apply. 3.1 laser welding method for joining similar or dissimilar metallic materials, using a laser

25、beam as heat source, with or without a metallic filler material (welding rod), which produces coalescence by melting the metallic materials in order to join them by creating a fusion zone 3.2 brazing method for joining similar or dissimilar metallic materials by applying heat and using a metallic br

26、azing material as filler NOTE 1 The brazing materials used have liquidus temperatures above 450 C, but below the melting range of the metallic materials being joined. They flow by capillary action into the gap between the metallic base materials and join them by creating a metallurgical bond. NOTE 2

27、 Brazing differs from welding in that brazing does not melt the metallic base materials. BS EN ISO 28319:2010ISO 28319:2010(E) 2 ISO 2010 All rights reserved4 Requirements 4.1 Chemical composition 4.1.1 Metallic materials to be joined The metallic materials to be joined shall comply with ISO 22674:2

28、006, 5.1 and 5.2. 4.1.2 Filler material 4.1.2.1 Chemical composition For all elements that are present in excess of 1,0 % (mass fraction), the percentage by mass of each of the constituent elements shall be declared by the manufacturer and shall be reported to a precision of 0,1 % (mass fraction). A

29、ny element that is present in a concentration in excess of 0,1 % (mass fraction), but not in excess of 1,0 % (mass fraction), shall be identified either by name or symbol. 4.1.2.2 Permitted deviation from the reported composition For silver-based or noble-metal-based filler materials, the percentage

30、 of each of the constituents shall not deviate by more than 0,5 % (mass fraction) from the values stated in the manufacturers instructions for use. For base-metal-based filler materials, all elements present with more than 20 % (mass fraction) shall not deviate from the value stated in the manufactu

31、rers instructions for use by more than 2 % (mass fraction). Those present in excess of 1 % (mass fraction) but not in excess of 20 % (mass fraction) shall not deviate from the value stated in the manufacturers instructions for use by more than 1 % (mass fraction). Testing shall be carried out in acc

32、ordance with 7.2. 4.1.3 Hazardous elements in filler material 4.1.3.1 Recognised hazardous elements For the purposes of this International Standard, the elements nickel, cadmium, beryllium and lead are designated to be hazardous elements. 4.1.3.2 Permitted limits for hazardous elements The filler ma

33、terial shall not contain more than 0,02 % (mass fraction) of cadmium or beryllium or lead. If the filler material contains more than 0,1 % (mass fraction) of nickel, the percentage shall not exceed the amount indicated on the package or label or insert. Testing shall be carried out in accordance wit

34、h 7.2. 4.2 Biocompatibility Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that, in assessing possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405. 4.3 Mechanica

35、l strength of laser-welded joint (tensile strength) The tensile strength of laser-welded specimens shall exceed 350 MPa. If the 0,2 % proof strength of either one or both of the metallic materials to be joined by laser welding is below 350 MPa, the tensile strength shall exceed the lower 0,2 % proof

36、 strength of the two. Testing shall be carried out in accordance with 7.3. BS EN ISO 28319:2010ISO 28319:2010(E) ISO 2010 All rights reserved 34.4 Corrosion resistance 4.4.1 Static immersion test The corrosion resistance of laser welded specimens shall be in the same range as that of the metallic ma

37、terials to be joined. The ion release shall not exceed twice that of the metallic material. If two different metallic materials are joined, the ion release shall not exceed twice that of the metallic material with the lesser corrosion resistance. The metallic materials to be joined and the laser-wel

38、ded specimens shall comply with ISO 22674:2006, 5.6. Testing shall be carried out in accordance with 7.4. 4.4.2 Appearance after corrosion exposure Magnified visual comparison prior to and after corrosion testing shall not reveal any visible selective corrosion in the vicinity of the laser weld. Tes

39、ting shall be carried out in accordance with 7.4. 5 Sampling The metallic filler material and the metallic material shall each be from one lot and shall be sufficient to prepare the specimens as required in 6.1 and 6.2, including provision for a second set for tensile testing. Further samples and pa

40、ckaging materials shall be made available for inspection in accordance with 9.2. If the proof strength values of 0,2 % non-proportional extension of the one or two metallic materials to be joined by laser welding are available from a test report in accordance with ISO 22674, these data can be used.

41、If not, perform the tests in accordance with ISO 22674 to determine the required proof strength values of 0,2 % non-proportional extension. 6 Preparation of specimens 6.1 General The specimens consist of the metallic materials joined by laser welding either with or without using a filler material ac

42、cording to the manufacturers instructions. Prepare casating alloy specimens by the “lost wax process“ of investment casting. If the manufacturer recommends a forming method other than casting, use this method to assess the suitability of the metallic material for laser welding. Follow the manufactur

43、ers instructions relating to the processing of the metallic material(s) and, if applicable, the filler material, including as regards the use of necessary aids and casting and welding equipment. Specimens with visible defects shall be discarded and replaced. Specimens shall be separated from sprues,

44、 casting beads/runners, fins and other projections. Surface contaminations shall be removed. The specimens shall be in the metallurgical state appropriate to their intended application. If heat-treatment is recommended by the manufacturer, perform the tests in the heat-treated state in accordance wi

45、th the manufacturers instructions. If laser welding is recommended following ceramic firing, the simulated ceramic firing of the specimens shall be in accordance with ISO 22674:2006, 7.2.3, and shall be applied before laser welding. BS EN ISO 28319:2010ISO 28319:2010(E) 4 ISO 2010 All rights reserve

46、d6.2 Specimens for tensile testing Prepare six specimens of the metallic material(s) to be laser-welded, which comply with either Figure 1 or Figure 2. Cut the specimens of the set at right angles to their long axis at the midpoint of the gauge length using a fine saw. Replace specimens that have vi

47、sible shrinkage, defects or porosities. Prepare the ends of the specimens to the recommended seam geometry. See A.7 for guidance on seam geometry. Support the two halves of the specimens and align them in an investment or a rigid jig. If two different metallic materials are to be laser-welded, use o

48、ne of each for the two halves. If a recommended filler material is used, follow the manufacturers instructions (see Clause 8). After laser welding, ensure that the diameter of each tensile specimen is within the tolerances given in Figure 1 or Figure 2, and does not show visual evidence of radial ru

49、n-out when rotated. Dimensions in millimetres aGauge length of (15 0,1) mm. bParallel section of test specimen of (18 0,1) mm. Figure 1 Test specimen with conical shoulders Dimensions in millimetres aGauge length of (15 0,1) mm. bParallel section of test specimen of (18 0,1) mm. Figure 2 Test specimen with radial shoulders BS EN ISO 28319:2010ISO 28319:2010(E) ISO 2010 All rights reserved 56.3 Specimens for corrosion testing Platelets for the preparation of specimens are prepared in accordance with ISO 10271. For cor