1、BS EN ISO 5832-3:2016Implants for surgery Metallic materialsPart 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 5832-3:2016 BRITISH STANDARDNational forewordThis British Standard is the UK i
2、mplementation of EN ISO 5832-3:2016. It supersedes BS EN ISO 5832-3:2012 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can be obtained on request to its se
3、cretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 87493 2 ICS 11.040.40 Compliance with a British Standard ca
4、nnot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 58
5、32-3 November 2016 ICS 11.040.40 Supersedes EN 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
6、de vanadium-4 (ISO 5832-3:2016) Chirurgische Implantate - 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 sti
7、pulate 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 European
8、 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 th
9、e 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, Romani
10、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, 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 a
11、ny means reserved worldwide for CEN national Members. Ref. No. EN ISO 5832-3:2016 EBS EN ISO 5832-3:2016EN ISO 5832-3:2016 (E) 3 European 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 C
12、EN/TC 55 “Dentistry” 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 May 2017, and conflicting national standards shall be withdrawn at the latest by May 2
13、017. 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. This document supersedes EN ISO 5832-3:2012. According to the CEN-CENELEC Interna
14、l Regulations, the national 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, Irel
15、and, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, 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. BS
16、EN ISO 5832-3:2016ISO 5832-3:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Chemical composition . 15 Microstructure 26 Mechanical properties 26.1 Tensile . 26.2 Bending 37 Test methods . 3Annex A (normative) Catalogues of metallographic micrographs o
17、f typical alpha+beta titanium microstructures 4Annex B (informative) Mechanical Properties Harmonization between ISO and ASTM wrought titanium 6-aluminium 4-vanadium Implant Material Standards . 5Bibliography 7 ISO 2016 All rights reserved iiiContents PageBS EN ISO 5832-3:2016ISO 5832-3:2016(E)Forew
18、ordISO (the International Organization for Standardization) is a worldwide federation 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 technic
19、al 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of el
20、ectrotechnical 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 different approval criteria needed for the different types of ISO documents should be noted. This document was
21、 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 be the subject of patent rights. ISO shall not be held responsible for identifying any or all such paten
22、t 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).Any trade name used in this document is information given for the convenience of users and does not co
23、nstitute an endorsement.For an explanation on the meaning of ISO specific terms and 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/i
24、so/foreword.html.The committee responsible for this document is ISO/TC 150, Implants 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
25、title Implants for surgery Metallic materials: 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-chromiu
26、m-molybdenum 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
27、-molybdenum alloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloyiv ISO 2016 All rights reservedBS EN ISO 5832-3:2016ISO 5832-3:2016(E)IntroductionNo known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long-te
28、rm clinical experience of the use of the material referred to in this part of ISO 5832 has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications. ISO 2016 All rights reserved vBS EN ISO 5832-3:2016BS EN ISO 5832-3:2016Implants for
29、 surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture
30、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 referencesThe following documents, in whole or in part, are normatively referenced in this
31、 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 6892-11), Metallic materials Tensile testing Part 1: Method of test at room temperat
32、ureISO 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 of (+) titanium alloy wrought products Part 003: Microstructure of plate3 Terms and
33、 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 temperature before the testSOURCE: ISO 6892-1:, 3.1.14 Chemical compositionThe heat/ingo
34、t 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 chemical requirements except hydrogen.The analysis of hydrogen shall be carried out aft
35、er 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 6892-1:2009)INTERNATIONAL STANDARD ISO 5832-3:2016(E) ISO 2016 All rights reserved
36、1BS EN ISO 5832-3:2016ISO 5832-3:2016(E)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 maximum hydrogen content
37、 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 refer to ASTM F136 (UNS
38、 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 each).6 Mechanical pr
39、operties6.1 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 Proof stress of nonpro
40、portional elongationPercentage elongation after fractureaMandrel diameter for bend testRmRp0,2min min AMPa 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 in square millimetres. T
41、he 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
42、Implant Material Standards, see Annex B.Should any of the test pieces not meet the specified requirements, or should they break outside the gauge limits, two further test pieces representative of the same batch shall be tested in the same manner. The alloy shall be deemed to comply only if both addi
43、tional test pieces meet the specified requirements.2 ISO 2016 All rights reservedBS EN ISO 5832-3:2016ISO 5832-3:2016(E)However, the manufacturer may re-heat-treat the material and resubmit it for testing in accordance with this part of ISO 5832. In this case, all parts shall be heat-treated in the
44、same fashion.6.2 BendingTitanium alloy sheet and strip, when tested in accordance with Clause 7, shall not show any cracking on the outside surface of the test piece.7 Test methodsThe test methods used in determining compliance with this part of ISO 5832 shall be those given in Table 3.Representativ
45、e test pieces for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO 6892-1.Table 3 Test methodsParameter Relevant clause Test methodChemical composition 4 Recognized analytical procedures (ISO methods where these exist)MicrostructureBarSheet and st
46、rip5 ISO 20160EN 3114003Mechanical properties 6 Tensile strength ISO 6892-1Proof stress of nonproportional elongationISO 6892-1Percentage elongation ISO 6892-1Bending ISO 7438Bend the sheet or strip through an angle of 105 around a mandrel of the diameter specified in Table 2. ISO 2016 All rights re
47、served 3BS EN ISO 5832-3:2016ISO 5832-3:2016(E)Annex A (normative) Catalogues of metallographic micrographs of typical alpha+beta titanium microstructuresIn this annex, two different standards are referenced showing microstructures of typical alpha+beta titanium alloy Ti 6Al 4V intended for the use
48、of identification and classification of the microstructure of a given material. ISO 20160 is presenting microstructures in the transverse section at 200 magnification. ISO 20160 applies to round bars up to a nominal diameter of 100 mm. It was replacing ETTC 2 Edition 2.Microstructures of flat rolled
49、 products, like sheet or plates, cannot be rated according to ETTC 2. For this type of product, another microstructural catalogue was made available. ETTC 4 Edition 2 is showing microstructures in the transverse section at 100 and 500 magnification. Product sizes of this catalogue were limited to a range of thicknesses above 5 mm and below 30 mm. The same microstructures are shown in EN 3114-003 but with different designations. Table A.1 shows the correlation of the designations of the micrographs
