1、BSI Standards PublicationBS ISO 5832-11:2014Implants for surgery MetallicmaterialsPart 11: Wrought titanium 6-aluminium 7-niobium alloyBS ISO 5832-11:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 5832-11:2014.It supersedes BS 7252-11:1995 which is withdr
2、awn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a con
3、tract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 83918 4ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the auth
4、ority of theStandards Policy and Strategy Committee on 30 September 2014.Amendments issued since publicationDate Text affectedBS ISO 5832-11:2014 ISO 2014Implants for surgery Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloyImplants chirurgicaux Produits base de mtaux Partie 1
5、1: Alliage forger base de titane, daluminium 6 et de niobium 7INTERNATIONAL STANDARDISO5832-11Second edition2014-09-15Reference numberISO 5832-11:2014(E)BS ISO 5832-11:2014ISO 5832-11:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise spe
6、cified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or
7、ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 5832-11:2014ISO 5832-11:2014(E) ISO 2014 All rights reserved iiiContents PageForeword
8、ivIntroduction v1 Scope . 12 Normative references 13 Chemical composition . 14 Microstructure 25 Mechanical properties 26 Test methods . 2BS ISO 5832-11:2014ISO 5832-11:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
9、 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. International organizations, gover
10、nmental 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 those intended for its further maintena
11、nce 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 (see www.iso.org/directives). Attenti
12、on 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 document will be in the Introduction a
13、nd/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 expressions related to conformity
14、 assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.This second
15、 edition cancels and replaces the first edition (ISO 5832-11:1994), 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 2: Unalloyed titanium Part 3: Wrought titanium 6-alum
16、inium 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-molybdenum-iron alloy Part 8: Wrought cobalt-nickel-chromium-
17、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 alloyiv ISO 2014 All rights reservedBS ISO 5832-11:2014
18、ISO 5832-11:2014(E)IntroductionNo known surgical implant material has ever been shown to be completely free of 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 an acceptable level of biological
19、response can be expected, when the material is used in appropriate applications. ISO 2014 All rights reserved vBS ISO 5832-11:2014BS ISO 5832-11:2014Implants for surgery Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloy1 ScopeThis part of ISO 5832 specifies the characteristics
20、 of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants.NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply
21、 with those specified in this part of ISO 5832.2 Normative referencesThe 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 o
22、f the referenced document (including any amendments) applies.ISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 20160:2006, Implants for surgery Metallic materials Classification of microstructures for alpha+beta titanium alloy bars3 Chemical compositionThe
23、heat analysis shall conform to the requirements as to the chemical composition prescribed in Table 1. Ingot analysis can be used for reporting all chemical requirements except hydrogen, which shall be determined after the heat treatment and pickling procedure.Table 1ElementCompositional limits % (m/
24、m)Aluminium 5,5 to 6,5Niobium 6,5 to 7,5Tantalum 0,50 max.Iron 0,25 max.Oxygen 0,20 max.Carbon 0,08 max.Nitrogen 0,05 max.Hydrogen 0,009 max.Titanium BalanceINTERNATIONAL STANDARD ISO 5832-11:2014(E) ISO 2014 All rights reserved 1BS ISO 5832-11:2014ISO 5832-11:2014(E)4 MicrostructureThe microstructu
25、re, when examined as indicated in Table 3, shall be alpha + beta, and shall correspond to ISO 20160:2006, micrograph A 1 to micrograph A 9, for annealed material.5 Mechanical propertiesThe tensile properties of the alloy, determined as specified in Clause 6, shall be in accordance with the requireme
26、nts of Table 2.Table 2 Mechanical properties of alloy in annealed conditionForm of alloyTensile strength min. MPaProof stress of non-proportional elongation min. MPaPercentage elonga-tion min. %Reduction of area min. %Bara900 800 10 25aMaximum diameter or thickness = 100 mm.Should any of the pieces
27、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 additional test pieces meet the specified requirements.If any of the retest
28、s fail to meet the appropriate requirements, the product represented shall be deemed not to comply with this part of ISO 5832.6 Test methodsThe test methods to be used in determining compliance with the requirements of this part of ISO 5832 shall be those given in Table 3.Representative test pieces
29、for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO 6892-1.Table 3 Test methodsRequirement Relevant clause Test methodsChemical composition 3 Recognized analytical procedures (International Standards where these exist)Microstructure 4 ISO 20160Me
30、chanical properties Tensile strength Proof stress of non-proportional elongation Percentage elongation Reduction of area5ISO 6892-1ISO 6892-1ISO 6892-1ISO 6892-12 ISO 2014 All rights reservedBS ISO 5832-11:2014BS ISO 5832-11:2014ISO 5832-11:2014(E) ISO 2014 All rights reservedICS 11.040.40Price base
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