DIN EN ISO 5832-3-2017 Implants for surgery - Metallic materials - Part 3 Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3 2016) German version EN ISO 5832-3 2016《外科植入物 金属.pdf

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1、March 2017 English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40; 77.120.50!%bo$“2637601w

2、ww.din.deDIN EN ISO 5832-3Implants for surgery Metallic materials Part 3: Wrought titanium 6aluminium 4vanadium alloy (ISO 58323:2016);English version EN ISO 58323:2016,English translation of DIN EN ISO 5832-3:2017-03Chirurgische Implantate Metallische Werkstoffe Teil 3: Titan 6Aluminium 4Vanadium K

3、netlegierung (ISO 58323:2016);Englische Fassung EN ISO 58323:2016,Englische bersetzung von DIN EN ISO 5832-3:2017-03Implants chirurgicaux Produits base de mtaux Partie 3: Alliage corroy base de titane, daluminium6 et de vanadium4 (ISO 58323:2016);Version anglaise EN ISO 58323:2016,Traduction anglais

4、e de DIN EN ISO 5832-3:2017-03SupersedesDIN EN ISO 58323:201208www.beuth.deDocument comprises 16 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.17 DIN EN ISO 5832-3:2017-03 2 A comma is used as the decimal marker. National

5、foreword This document (EN ISO 5832-3:2016) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (

6、DIN Standards Committee Dentistry), Working Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 6892-1 DIN EN ISO 6892-1 ISO 7438 DIN EN ISO 7438 ISO 5832 “Implants for surgery Metallic materials”

7、 consists of the following parts: Part 1: Wrought stainless steel Part 2: Unalloyed titanium Part 3: Wrought titanium 6-aluminium 4-vanadium alloy Part 4: Cobalt-chromium-molybdenum casting alloy Part 5: Wrought cobalt-chromium-tungsten-nickel alloy Part 6: Wrought cobalt-nickel-chromium-molybdenum

8、alloy Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy Part 9: Wrought high nitrogen stainless steel Part 11: Wrought titanium 6-aluminium 7-niobium alloy Part 12: Wrought cobalt-chromium-molybdenum a

9、lloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy Amendments This standard differs from DIN EN ISO 5832-3:2012-08 as follows: a) the test of the alpha + beta globular structure of the microstructure shall be carried out to correspond to photomicrographs A1 to A9 in ISO 20160

10、 for round bars or to photomicrographs 3T1 to 3T3 in EN 3114-003 for sheets and plates (i. e. ETTC 2 has been replaced); b) Annex A on metallographic micrographs of typical microstructures has been added; DIN EN ISO 5832-3:2017-03 3 c) Annex B on the harmonization of mechanical properties between IS

11、O and ASTM material standards has been added. In this annex, the respective higher value from these standards is indicated, e. g., this also applies for the specific ELI grade. Previous editions DIN ISO 5832-3: 2000-08 DIN EN ISO 5832-3 2012-08 National Annex NA (informative) Bibliography DIN EN ISO

12、 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature DIN EN ISO 7438, Metallic materials Bend test DIN EN ISO 5832-3:2017-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5832-3 November 2016 ICS 11.040.40 Supersedes EN

13、ISO 5832-3:2012English Version Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy(ISO 5832-3:2016) Implants chirurgicaux - Produits base de mtaux - Partie 3: Alliage corroy base de titane, daluminium-6 et de vanadium-4 (ISO 5832-3:2016) Chirurgische Imp

14、lantate - Metallische Werkstoffe -Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierung(ISO 5832-3:2016) This European Standard was approved by CEN on 12 September 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Sta

15、ndard 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 European Standard exists in three official versions (Engli

16、sh, 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 the national standards bodies of Austria, Belgium, B

17、ulgaria, 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

18、 Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membe

19、rs. Ref. No. EN ISO 5832-3:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Chemical composition . 65 Microstructure 76 Mechanical properties 76.1 Tensile . 76.2 Bending 87 Test methods . 8Annex A (normative) Catalogues of metallographic microgr

20、aphs of typical alpha+beta titanium microstructures 9Annex B (informative) Mechanical Properties Harmonization between ISO and ASTM wrought titanium 6-aluminium 4-vanadium Implant Material Standards 10Bibliography . 12Contents PageDIN EN ISO 5832-3:2017-03 EN ISO 5832-3:2016 (E) 2Foreword .4European

21、 foreword This document (EN ISO 5832-3:2016) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, ei

22、ther by publication of an identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CEN

23、ELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 5832-3:2012. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Be

24、lgium, 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, Romania, Slovakia, Slovenia, Spain, Sweden, Swit

25、zerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5832-3:2016 has been approved by CEN as EN ISO 5832-3:2016 without any modification. DIN EN ISO 5832-3:2017-03 EN ISO 5832-3:2016 (E) 3 ForewordISO (the International Organization for Standardization) is a worldwide federatio

26、n of national standards bodies (ISO member bodies). The work of preparing International 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.

27、 International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and thos

28、e intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different 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 (s

29、ee www.iso.org/directives).Attention is drawn to the possibility 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. Details of any patent rights identified during the development of the docu

30、ment will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).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 meaning of ISO specific terms and

31、expressions related to conformity assessment, as well as information about ISOs 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.The committee responsible for this document is ISO/TC 150, Implants

32、 for surgery, Subcommittee SC 1, Materials.This fourth edition cancels and replaces the third edition (ISO 5832-3:1996), which has been technically revised.ISO 5832 consists of the following parts, under the general title Implants for surgery Metallic materials: Part 1: Wrought stainless steel Part

33、2: Unalloyed titanium Part 3: Wrought titanium 6-aluminium 4-vanadium alloy Part 4: Cobalt-chromium-molybdenum casting alloy Part 5: Wrought cobalt-chromium-tungsten-nickel alloy Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybden

34、um-iron alloy Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy Part 9: Wrought high nitrogen stainless steel Part 11: Wrought titanium 6-aluminium 7-niobium alloy Part 12: Wrought cobalt-chromium-molybdenum alloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium al

35、loyDIN EN ISO 5832-3:2017-03 EN ISO 5832-3:2016 (E) 4 IntroductionNo known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 5832 has shown that a

36、n acceptable level of biological response can be expected when the material is used in appropriate applications.DIN EN ISO 5832-3:2017-03 EN ISO 5832-3:2016 (E) 5 1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as ti

37、tanium 6-aluminium 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants.NOTE The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.2 Normative referenc

38、esThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 68

39、92-11), Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 7438, Metallic materials Bend testISO 20160, Implants for surgery Metallic materials Classification of microstructures for alpha+beta titanium alloy barsEN 3114-003, Aerospace series Test method Microstructure o

40、f (+) titanium alloy wrought products Part 003: Microstructure of plate3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 6892-1 and the following apply.3.1original gauge lengthLolength between gauge length marks on the test piece measured at room temper

41、ature before the testSOURCE: ISO 6892-1:, 3.1.14 Chemical compositionThe heat/ingot analysis of a representative sample of the alloy when determined in accordance with Clause 6 shall comply with the chemical composition specified in Table 1.NOTE 1 Ingot analysis may be used for determining all chemi

42、cal requirements except hydrogen.The analysis of hydrogen shall be carried out after the final heat treatment and final surface treatment.Requirements for the major and minor elemental constituents for titanium 6-aluminium 4-vanadium alloy are listed in Table 1.1) To be published. (Revision of ISO 6

43、892-1:2009)DIN EN ISO 5832-3:2017-03 EN ISO 5832-3:2016 (E) 6 Table 1 Chemical compositionElement Compositional limits% (m/m)Aluminium 5,5 to 6,75Vanadium 3,5 to 4,5Iron 0,3 max.Oxygen 0,2 max.Carbon 0,08 max.Nitrogen 0,05 max.Hydrogen 0,015 max.aTitanium BalanceaExcept for billets, for which the ma

44、ximum hydrogen content shall be 0,010 % (m/m).NOTE 2 A grade with more restrictive limits of oxygen and iron is known under the term “extra low interstitials” (ELI). Commercially available ELI material can also be ordered using this part of ISO 5832. For exact compositional limits of the ELI grade r

45、efer to ASTM F136 (UNS R54601) (www.astm.org).5 MicrostructureThe microstructure, when examined as indicated in Table 3, shall be alpha + beta globular and shall correspond to photomicrographs A1 to A9 in ISO 20160 for round bars or 3T1 to 3T13 in EN 3114-003 for sheet and plates (annealed condition

46、 each).6 Mechanical properties6.1 TensileThe tensile properties of the alloy, when tested in accordance with Clause 7, shall comply with the values specified in Table 2.Table 2 Mechanical properties of wrought titanium 6-aluminium 4-vanadium alloy in annealed conditionForm of alloy Tensile strength

47、Proof stress of nonproportional elongationPercentage elongation after fractureaMandrel diameter for bend testRmRp0,2min min A MPa MPa min mmSheet and stripc860 780 8 10 tbBarc860 780 10 not applicableaOriginal gauge length L0equal to (5,65 S0) or 50 mm, where S0is the original cross-sectional area i

48、n square millimetres. The original gauge length chosen for testing shall be reported with the test results.bt is the thickness of the sheet or strip.cMaximum diameter or thickness is equal to 75 mm.NOTE For information on the Mechanical Properties Harmonization between ISO and ASTM wrought titanium 6-aluminium 4-vanadium Implant Material Standards, see Annex B.Should any of