EN ISO 28319-2018 Dentistry - Laser welding and filler materials.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry Laser welding and filler materials (ISO 28319:2018)BS EN ISO 28319:2018National forewordThis British Standard is the UK implementation of EN ISO 28319:2018. It supersedes BS EN ISO 28319:2010, which is withdra

2、wn.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract.

3、 Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 93303 5ICS 11.060.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authorit

4、y of the Standards Policy and Strategy Committee on 30 June 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 28319:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 28319May 2018ICS 11.060.10 Supersedes EN ISO 28319:2010EUROPEAN COMMITTEE FOR STA

5、NDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 28319:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry - Laser welding

6、and filler materials (ISO 28319:2018)Mdecine bucco-dentaire - Soudage par laser et matriaux dapport (ISO 28319:2018)Zahnheilkunde - Laserschweien (ISO 28319:2018)This European Standard was approved by CEN on 15 March 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations whic

7、h 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 application to the CEN-CENELEC Management Centre or to any CEN member.This Euro

8、pean 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-CENELEC Management Centre has the same status as the official versions.CEN members are

9、 the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom

10、ania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 28319:2018 (E)European forewordThis document (EN ISO 28319:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistr

11、y” 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 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Atten

12、tion is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 28319:2010.According to the CEN-CENELEC Internal Regulations, the national

13、standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani

14、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 28319:2018 has been approved by CEN as EN ISO 28319:2018 without any modification.iiBS EN ISO 28319:2018ISO 28

15、319:2018Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Chemical composition 24.1.1 Metallic materials to be joined. 24.1.2 Filler material . 24.1.3 Hazardous elements in filler material . 24.2 Biocompatibility 24.3 Mechanical strength of laser welded joi

16、nt (tensile strength) . 24.4 Corrosion resistance 34.4.1 Static immersion test . 34.4.2 Appearance after corrosion exposure . 34.5 Laser welding process 35 Sampling 36 Preparation of specimens . 36.1 General . 36.2 Specimens for tensile testing 46.2.1 General 46.2.2 Procedure . 46.3 Specimens for co

17、rrosion testing 56.3.1 General 56.3.2 Seam geometry 57 Measurement and test methods . 67.1 Visual inspection . 67.2 Chemical composition 67.3 Tensile testing 67.3.1 General 67.3.2 Evaluation of tensile testing results 67.3.3 Calculation of tensile strength . 77.4 Corrosion resistance by static immer

18、sion test 77.4.1 Reagents 77.4.2 Apparatus . 77.4.3 Test solution. 77.4.4 Test procedure . 77.4.5 Analysis 77.4.6 Microscopic inspection . 87.4.7 Report 88 Instruction for use 89 Marking and labelling . 89.1 Marking . 89.2 Labelling . 810 Test report . 9Annex A (informative) Laser welding process .1

19、0Bibliography .13 ISO 2018 All rights reserved iiiContents PageBS EN ISO 28319:2018ISO 28319:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carr

20、ied 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 work.

21、ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the differe

22、nt approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may b

23、e the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents)

24、.Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about IS

25、Os adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.This second edition cancels

26、and replaces the first edition (ISO 28319:2010), which has been technically revised.The main changes compared to the previous edition are as follows:a) reference to the corrosion standard ISO 10271:2011, for corrosion test methods and measurements has been added;b) a corrosion limit for the static c

27、orrosion test has been specified;c) Annex A has been revised in order to describe the laser welding process.iv ISO 2018 All rights reservedBS EN ISO 28319:2018Dentistry Laser welding and filler materials 1 ScopeThis document specifies requirements and test methods for laser welding and the filler ma

28、terials thereto used in the dental laboratory for welding of metallic restorations and appliances.For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.2 Normative referencesThe following documents are referr

29、ed to in the text in such a way that some or all of their content constitutes requirements 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 VocabularyIS

30、O 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 10271:2011, Dentistry Corrosion test methods for metallic materialsISO 15223-1:2016, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirem

31、entsISO 22674:2016, Dentistry Metallic materials for fixed and removable restorations and appliances3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 22674 and the following apply.ISO and IEC maintain terminological databases for use in standa

32、rdization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1laser weldingmethod for joining similar or dissimilar metallic materials, using a laser beam as the heat source, with or without a meta

33、llic filler material (welding rod), which produces coalescence by melting abutting zones of metallic material components thereby creating a common fusion zone3.2filler materialmetallic filling material used for laser welding (3.1)INTERNATIONAL STANDARD ISO 28319:2018 ISO 2018 All rights reserved 1BS

34、 EN ISO 28319:2018ISO 28319:20184 Requirements4.1 Chemical composition4.1.1 Metallic materials to be joinedThe metallic materials to be joined shall conform to ISO 22674:2016, 5.1 and 5.2.4.1.2 Filler material4.1.2.1 Chemical compositionFor all elements that are present in excess of 1,0 % (mass frac

35、tion), 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).Any element that is present in a concentration in excess of 0,1 % (mass fraction), but not in excess of 1,0 % (mass fraction), shall b

36、e identified either by name or symbol.4.1.2.2 Permitted deviation from the reported compositionFor silver or noble-metal elements in filler materials, the percentage shall not deviate by more than 0,5 % (mass fraction) from the values stated in the instructions for use.For base-metal elements in fil

37、ler materials, all elements, present with more than 20 % (mass fraction) shall not deviate from the value stated in the 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 sta

38、ted in the instructions for use by more than 1 % (mass fraction).4.1.3 Hazardous elements in filler material4.1.3.1 Recognized hazardous elementsFor the purposes of this document the elements nickel, cadmium, beryllium and lead are designated to be hazardous elements.4.1.3.2 Permitted limits for haz

39、ardous elementsThe filler material shall contain no 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.4.2 Biocompatibility

40、Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this document, but it is recommended that, in assessing possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.4.3 Mechanical strength of laser welded joint (tensile s

41、trength)If the 0,2 % proof strength of both of the metallic materials to be joined by laser welding is more than 350 MPa, the tensile strength of laser-welded specimens shall be at least 350 MPa.If the 0,2 % proof strength of either one or both of the metallic materials to be joined by laser welding

42、 is below 350 MPa, the tensile strength shall exceed the lower 0,2 % proof strength of the two.Testing shall be carried out in accordance with 7.3.2 ISO 2018 All rights reservedBS EN ISO 28319:2018ISO 28319:20184.4 Corrosion resistance4.4.1 Static immersion testWhen pieces of a single metallic mater

43、ial are joined, the metal ion release shall not exceed 200 g cm2in a time period of 7 d 1 h.The metallic materials to be joined and the laser welded specimens shall conform to ISO 22674:2016, 5.7. Testing shall be carried out in accordance with 7.4.4.4.2 Appearance after corrosion exposureMagnified

44、visual comparison prior to and after corrosion testing shall not reveal any visible selective corrosion in the vicinity of the laser weld.Testing shall be carried out in accordance with 7.4.4.5 Laser welding processSpecific information about the laser welding process is given in Annex A.5 SamplingTh

45、e metallic filler material and the metallic material each shall be from one lot. It 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 packaging materials shall be made available for inspection in acco

46、rdance 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 according to ISO 22674, these data can be used. If not, perform the tests according to ISO 22674 to determine the requi

47、red values of proof strength of 0,2 % non-proportional extension.6 Preparation of specimens6.1 GeneralThe specimens consist of the metallic materials joined by laser welding either with or without using a filler material according to the instructions for use. For casting alloys to be tested prepare

48、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 tested for suitability for laser welding. Use such a method, if recommended by the manufacturer. Follow the instruction for use relati

49、ng to the processing of the metallic material(s) and if applicable the filler material including 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, casting beads/runners, fins and other projections. Surface contaminations shall be removed.The specimens shall be in the metallurgical state(s) appropriate to their intended application(s).If a heat-treatment is recommended by the manufacturer, perform the tests in the heat-treated