1、BSI Standards PublicationBS ISO 5832-4:2014Implants for surgery MetallicmaterialsPart 4: Cobalt-chromium-molybdenumcasting alloyBS ISO 5832-4:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 5832-4:2014. It supersedes BS 7252-4:1997 which is withdrawn.The U
2、K 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 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 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 83917 7 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the author
4、ity of the Standards Policy and Strategy Committee on 30 September 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e d ISO 2014Implants for surgery Metallic materials Part 4: Cobalt-chromium-molybdenum casting alloyImplants chirurgicaux Produits base de mtaux Partie 4: Al
5、liage couler base de cobalt, de chrome et de molybdneINTERNATIONAL STANDARDISO 5832-4Third edition 2014-09-15Reference number ISO 5832-4:2014(E)BS ISO 5832-4:2014ISO 5832-4:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no
6、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 ISOs member
7、 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 5832-4:2014ISO 5832-4:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroductio
8、n v1 Scope . 12 Normative references 13 Chemical composition . 14 Mechanical properties 25 Test methods . 2BS ISO 5832-4:2014ISO 5832-4:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep
9、aring 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, governmental and non-governmental, in
10、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 maintenance are described in the ISO/IEC
11、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). Attention is drawn to the possibility th
12、at 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 and/or on the ISO list of patent d
13、eclarations 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 assessment, as well as informati
14、on 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 third edition cancels and replaces the
15、second edition (ISO 5832-4:1996), 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 2: Unalloyed titanium Part 3: Wrought titanium 6-aluminium 4-vanadium alloy Part 4: Cob
16、alt-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-molybdenum-tungsten-iron alloy Par
17、t 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 5832-4:2014ISO 5832-4:2014(E)IntroductionNo kn
18、own 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 an acceptable level of biological response can be expected, when the mat
19、erial is used in appropriate applications. ISO 2014 All rights reserved vBS ISO 5832-4:2014BS ISO 5832-4:2014Implants for surgery Metallic materials Part 4: Cobalt-chromium-molybdenum casting alloy1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, coba
20、lt-chromium-molybdenum casting 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 might not necessarily comply with the specifications given in this part of ISO 5832.2 Normative referencesThe following
21、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 6892-1, Metallic m
22、aterials Tensile testing Part 1: Method of test at room temperature3 Chemical compositionThe heat analysis of a representative sample of the alloy when determined in accordance with Clause 5 shall comply with the chemical composition specified in Table 1.Requirements for the major and minor elementa
23、l constituents for cobalt-chromium-molybdenum casting alloy are listed in Table 1.Table 1 Chemical compositionElementCompositional limits % (m/m)Chromium 26,5 to 30,0Molybdenum 4,5 to 7,0Nickel 1,0 max.Iron 1,0 max.Carbon 0,35 max.Manganese 1,0 max.Silicon 1,0 max.Cobalt BalanceINTERNATIONAL STANDAR
24、D ISO 5832-4:2014(E) ISO 2014 All rights reserved 1BS ISO 5832-4:2014ISO 5832-4:2014(E)4 Mechanical propertiesThe tensile properties of the alloy, when tested in accordance with Clause 5, shall comply with the specified values in Table 2.Table 2 Mechanical propertiesTensile strength Rmmin. MPaProof
25、stress of non-proportional elongation Rp0,2min. MPaPercentage elongation after frac-tureaA min.665 450 8aGauge length = 5,65 Somm or 50 mm, where Sois the original cross-sectional area, in square millimetres.Should any of the test pieces not meet the specified requirements, or should they break outs
26、ide 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.However, the manufacturer can re-heat treat the material and resubmit it for test
27、ing in accordance with this part of ISO 5832. In this case, all parts should be heat-treated in the same fashion.5 Test methodsThe test methods used in determining compliance with this part of ISO 5832 shall be those given in Table 3.Representative test pieces for the determination of mechanical pro
28、perties shall be prepared in accordance with ISO 6892-1.Table 3 Test methodsParameter Relevant clause Test methodChemical composition 3 Recognized analytical procedures (International Standards where these exist)Mechanical properties Tensile strength Proof stress of non-proportional elongation Perce
29、ntage elongation4ISO 6892-1ISO 6892-1ISO 6892-12 ISO 2014 All rights reservedBS ISO 5832-4:2014BS ISO 5832-4:2014ISO 5832-4:2014(E) ISO 2014 All rights reservedICS 11.040.40Price based on 2 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standards and
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