1、BS ISO 5832-7:2016Implants for surgery Metallic materialsPart 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloyBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 5832-7:2016 BRITISH STANDARDNational forewordThis British Standard is the UK
2、implementation of ISO 5832-7:2016. It supersedes BS 7252-7:1994 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.A list of organizations represented on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 secretary.
3、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 90838 5 ICS 11.040.40 Compliance with a British Standard cannot con
4、fer 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 dBS ISO 5832-7:2016 ISO 2016Implants for surgery Metallic materials
5、Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloyImplants chirurgicaux Produits base de mtaux Partie 7: Alliage forger mis en forme froid base de cobalt, de chrome, de nickel, de molybdne et de ferINTERNATIONAL STANDARDISO5832-7Third edition2016-11-15Reference numberISO
6、5832-7:2016(E)BS ISO 5832-7:2016ISO 5832-7:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic
7、 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 body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Gen
8、eva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 5832-7:2016ISO 5832-7:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Chemical composition . 15 Microstructure 25.1 Grain size 25.2 Inclusion content. 26 Mechani
9、cal properties 27 Test methods . 3 ISO 2016 All rights reserved iiiContents PageBS ISO 5832-7:2016ISO 5832-7:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standar
10、ds 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 liaison with ISO, also take
11、 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 Directives, Part 1. In part
12、icular 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 that some of the elements of t
13、his 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 declarations received (see ww
14、w.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 information about ISOs adherence to th
15、e 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 for surgery, Subcommittee SC 1, Materials.This third edition cancels and replaces the second e
16、dition (ISO 5832-7:1994), which has been technically revised.A list of all parts in the ISO 5832 series can be found on the ISO website.iv ISO 2016 All rights reservedBS ISO 5832-7:2016ISO 5832-7:2016(E)IntroductionNo known surgical implant material has ever been shown to be completely free of adver
17、se reactions in the human body. However, long-term clinical experience of the use of the material referred to in this document has shown that an acceptable level of biological response can be expected when the material is used in appropriate conditions. ISO 2016 All rights reserved vBS ISO 5832-7:20
18、16BS ISO 5832-7:2016Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy1 ScopeThis document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
19、for use in the manufacture of surgical implants.NOTE The mechanical properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.2 Normative referencesThe following documents are referred to in the text in such a way that
20、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 643, Steels Micrographic determination of the apparent grain size
21、ISO 4967, Steel Determination of content of non-metallic inclusions Micrographic method using standard diagramsISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature3 Terms and definitionsNo terms and definitions are listed in this document.ISO and IEC maintain ter
22、minological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp4 Chemical compositionThe heat analysis of the alloy when determined as specified in Clause 7 shall
23、comply with the chemical composition specified in Table 1. The analysis of samples taken from products manufactured from the alloy shall also comply with Table 1.INTERNATIONAL STANDARD ISO 5832-7:2016(E) ISO 2016 All rights reserved 1BS ISO 5832-7:2016ISO 5832-7:2016(E)Table 1 Chemical compositionEl
24、ementElement compositional limits,% (m/m)Cobalt 39 to 42Chromium 18,5 to 21,5Nickel 14 to 18Molybdenum 6,5 to 8,0Manganese 1,0 to 2,5Silicon 1 max.Carbon 0,15 max.Phosphorus 0,015 max.Sulfur 0,015 max.Beryllium 0,001 max.Iron Balance5 Microstructure5.1 Grain sizeThe microscopic structure shall be un
25、iform. The grain size, determined as specified in Clause 7, shall be no coarser than grain size No. 5.5.2 Inclusion contentThe non-metallic inclusion content of the alloy, determined as specified in Clause 7, shall not exceed the limits given in Table 2.Table 2 Inclusion content limitsType of inclus
26、ion Inclusion content thinaA SulfidesB AluminatesC SilicatesD Oxides, globular1313aThere shall be no thick inclusions.6 Mechanical propertiesThe mechanical properties, determined as specified in Clause 7, shall be in accordance with the requirements of Table 3.2 ISO 2016 All rights reservedBS ISO 58
27、32-7:2016ISO 5832-7:2016(E)Table 3 Mechanical propertiesConditionTensile strengthmin.MPaProof stress of non- proportional elongationmin.MPaPercentage elongationmin.%Annealed 950 450 65Hot worked 950 600 2030 % cold-worked 1 450 1 300 8Spring tempera1 650 1 400 1aFor specific applications.7 Test meth
28、odsThe test methods to be used in determining compliance with the requirements of this document shall be those given in Table 4.Table 4 Test methodsRequirementRelevant clause or subclauseTest methodChemical compositionClause 4Recognized analytical procedures (ISO methods where these exist)Inclusion
29、content 5.2 ISO 4967Grain size 5.1 ISO 643Mechanical propertiesTensile strengthPercentage elongationProof stress of non-proportional elongationClause 6 ISO 6892-1 ISO 2016 All rights reserved 3BS ISO 5832-7:2016ISO 5832-7:2016(E) ISO 2016 All rights reservedICS 11.040.40Price based on 3 pagesThis pa
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