BS ISO 20160-2009 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars《外科植入物 金属材料 α+β钛合金棒材的微观结构分类》.pdf

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1、BS ISO 20160:2006 ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Implants for surgery Metallic materials Classification of microstructures for alpha+beta titanium alloy barsThis British Standard was published under the authority of the Standards

2、 Policy and Strategy Committee on 2 2009 BSI 2009 ISBN 978 0 580 53153 8 Amendments/corrigenda issued since publication Date Comments BS ISO 20160:2006 National foreword This British Standard is the UK implementation of ISO 20160:2006. The UK participation in its preparation was entrusted to Technic

3、al 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. Users are responsible for its correct application. Compl

4、iance with a British Standard cannot confer immunity from legal obligations. February 8BS ISO 20160:2006Reference number ISO 20160:2006(E) ISO 2006INTERNATIONAL STANDARD ISO 20160 First edition 2006-05-01 Corrected version 2006-09-15 Implants for surgery Metallic materials Classification of microstr

5、uctures for alpha+beta titanium alloy bars Implants chirurgicaux Matriaux mtalliques Classification des microstructures des barres en alliages de titane alpha+bta BS ISO 20160:2006 ISO 20160:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing poli

6、cy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central

7、Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken t

8、o ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or

9、utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11

10、Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reservedBS ISO 20160:2006 ISO 20160:2006(E) ISO 2006 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards

11、 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. International organiza

12、tions, 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. International Standards are drafted in accordance with the rules given in t

13、he ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of

14、 the member bodies casting a vote. 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. ISO 20160 was prepared by Technical Committee ISO/TC 150, Implants

15、 for surgery, Subcommittee SC 1, Materials. This corrected version of ISO 20160:2006 incorporates the following corrections: page 1, definition 3.1, where alpha and beta phases are more clearly mentioned and the crystal structure is correctly termed body-centred cubic; there is also a correction in

16、the NOTE; page 3, 5.2, paragraphs 1 and 2 (this excludes the NOTE), there are minor changes in phraseology and symbols; pages 5 to 8, the quality of the micrographs, A 1 to A 24, has been improved. BS ISO 20160:2006 ISO 20160:2006(E) iv ISO 2006 All rights reservedIntroduction Some ISO Standards on

17、alpha+beta titanium implant materials refer to a set of microstructural configurations provided in the ETTC 2 brochure which was published first in 1979 by the Technical Committee of European Titanium Producers 1 . A reprint of ETTC 2 containing some additions was made available in 1995. In contrast

18、 to homogeneous material structures for which standards are available to determine the grain size of the microstructures (ISO 643, ASTM E112), no standards exist for the classification of the more complex alpha+beta titanium microstructures, although the alpha+beta alloys are the most frequently use

19、d technical titanium materials. This International Standard follows the repeated request to make available the relevant set of microstructures of alpha+beta titanium alloy bars from the ETTC 2 publication as a standard document for easy access. The ISO Technical Committee ISO/TC 150/SC 1 Materials,

20、expresses its gratitude to the publishers of the ETTC 2 brochure for granting the reproduction of selected micrographs for the purpose of this International Standard. BS ISO 20160:2006 INTERNATIONAL STANDARD ISO 20160:2006(E) ISO 2006 All rights reserved 1 Implants for surgery Metallic materials Cla

21、ssification of microstructures for alpha+beta titanium alloy bars IMPORTANT For the correct identification of microstructures, it is necessary to use reference micrographs of suitable quality and precise dimensions as contained in this International Standard. Owing to the fact that electronic copies

22、 of these reference micrographs are subject to change when viewed on screen or printed, it is recommended that only the micrographs contained in printed copies of this International Standard purchased from ISO or ISO members and their distributors be used for purposes of comparison. 1 Scope This Int

23、ernational Standard provides a catalogue of metallographic photomicrographs for the designation of microstructures of alpha+beta titanium alloys in the form of bars that are intended for the manufacture of surgical implants. This International Standard is applicable to bars of diameter no greater th

24、an 100 mm or the equivalent. This catalogue of microstructures is intended to serve as an aid in the communication on general types of microstructures of alpha+beta titanium alloy bars. The designation of the microstructures is based on morphological appearance. Actual microstructures can also appea

25、r as a combination of the type of micrographs shown. This International Standard does not contain specific microstructural requirements. The catalogue includes photomicrographs of desirable and undesirable microstructures that can develop during the processing of alpha+beta titanium alloys. The sele

26、ction of acceptable microstructures is subject to agreement under the consideration of implant application and relevant material standards. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited a

27、pplies. For undated references, the latest edition of the referenced document (including any amendments) applies. ASTM E407-99, Standard Practice for Microetching Metals and Alloys 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 alpha+beta ti

28、tanium alloys titanium alloys composed of alloying elements which propagate the stabilization of the titanium alpha and beta phases with hexagonal and body-centred cubic atomic structures, respectively NOTE The constitution diagrams of these alloys present typically alpha+beta phase regions that are

29、 stable down to room temperature (see also 4.1). BS ISO 20160:2006 ISO 20160:2006(E) 2 ISO 2006 All rights reserved3.2 alpha+beta (titanium) microstructures metallographic microstructures of alpha+beta titanium alloys that contain predominantly the alpha/beta phase NOTE Metastable phases can be incl

30、uded. 3.3 bar material material processed in the longitudinal direction provided in form of (straight) bars with a specified cross- sectional shape NOTE Bar material is distinct from wire, which is supplied in spools. 4 General considerations and applicability 4.1 General considerations Pure titaniu

31、m transforms from the hexagonal atomic structure (alpha phase) into the body-centred cubic structure (beta phase) at the temperature of 882 C. Below this transition temperature the cubic beta phase is not stable. However, the addition of certain alloying elements stabilizes the beta phase at lower t

32、emperatures. By this means typical so-called alpha+beta titanium alloys have been developed where the alpha and beta phases are stable at room temperature. Through the addition of alloying elements the transition temperature, the so-called Beta-Transus, will be changed. With the presence of alpha+be

33、ta structure the mechanical properties of the titanium can be altered 2 . Depending on the material composition and the processing history, different microstructural configurations appear. The catalogue of metallographic micrographs given in Annex A contains typical microstructural configurations as

34、 they occur in the metallurgical processing of alpha+beta titanium alloys, of which the titanium with 6 % aluminium and 4 % vanadium is considered representative. 4.2 Applicability The micrographs given in Annex A are identified by the letter “A” followed by a number. This classification of microgra

35、phs is intended as a basis for the communication on typical morphological microstructural conditions viewed on transverse metallographic sections of bar material. The choice of the desired and undesired microstructural configurations may depend on the application of the material, the applicable mate

36、rial standards, as well as agreements. The micrographs in Annex A were originally published in ETTC 2 for Ti-6Al-4V bar material, but are also applicable to other alpha+beta alloys applied for surgical implants 3, 4 . 5 Procedure 5.1 Magnification The micrographs A 1 to A 24 in Annex A represent tra

37、nsverse sections of bar material at a magnification of 200. 5.2 Identification In order to identify the type of microstructure of a given alpha+beta titanium material by comparison with the micrographs in Annex A, transverse sections of the material shall be prepared metallographically and etched. B

38、S ISO 20160:2006 ISO 20160:2006(E) ISO 2006 All rights reserved 3 Etching techniques suitable for titanium alloys which give results similar to those shown on the micrographs in Annex A shall be applied. If guidance is needed for microetching techniques, ASTM E407-99 shall be applied. The etchant nu

39、mber 192 listed is commonly applied and recommended. NOTE Within the concentration range of etchant number 192, a solution composed of 100 ml H 2 O + 2 ml HF (40 % mass fraction) + 8 ml HNO 3( = 1,4) has been found suitable in routine practice. The metallographic sections are examined at 200 magnifi

40、cation using an optical microscope and bright field illumination. The most similar type of microstructure is selected by comparison with Annex A and its designation is reported (e.g. Type A X). Additional information may be added (e.g. Type A 3 but with apparently smaller alpha grain size). In case

41、it is desired to determine the grain size of the matrix in a given microstructure, ISO 643 should apply 5 . In case a given microstructure is in between two types of micrographs both may be identified (e.g. “Type A 1/A 2”). Where the type of microstructure varies over the cross-section of a material

42、 sample, the type of microstructural characteristic of the different areas of the cross-section may be identified. BS ISO 20160:2006 ISO 20160:2006(E) 4 ISO 2006 All rights reservedAnnex A (normative) Catalogue of metallographic micrographs of typical alpha+beta titanium microstructures of transvers

43、e sections of bar material of diameters no greater than 100 mm or its equivalent For identification of the microstructure of a given material by comparison with the following micrographs, the material shall be viewed at a microscopic magnification of 200. NOTE 1 Microstructures corresponding to the

44、micrographs A 20 to A 24 are classified as unacceptable in ETTC 2 edition 1. NOTE 2 The order and designation of micrographs in Annex A relate to the arrangement given in the second edition (1995) of the ETTC 2 publication. The first edition contains the same micrographs, however the order of the mi

45、crographs with the designations A 10 to A 17 differs. In order to avoid confusion, the correlation of the designation of the micrographs between edition 1 and 2 of ETTC 2 are given in Table A.1. Table A.1 Correlation between designations of micrographs ETTC 2 edition 1 ETTC 2 edition 2 A 10 A 17 A 1

46、1 A 10 A 12 A 11 A 13 A 12 A 14 A 13 A 15 A 14 A 16 A 15 A 17 A 16 BS ISO 20160:2006 ISO 20160:2006(E) ISO 2006 All rights reserved 5A 1 200 A 2 200 A 3 200 A 4 200 A 5 200 A 6 200 BS ISO 20160:2006 ISO 20160:2006(E) 6 ISO 2006 All rights reservedA 7 200 A 8 200 A 9 200 A 10 200 A 11 200 A 12 200 BS

47、 ISO 20160:2006 ISO 20160:2006(E) ISO 2006 All rights reserved 7A 13 200 A 14 200 A 15 200 A 16 200 A 17 200 A 18 200 BS ISO 20160:2006 ISO 20160:2006(E) 8 ISO 2006 All rights reservedA 19 200 A 20 200 A 21 200 A 22 200 A 23 200 A 24 200 BS ISO 20160:2006 ISO 20160:2006(E) ISO 2006 All rights reserv

48、ed 9 Bibliography 1 Publication ETTC 2, Microstructural standards for alpha+beta titanium alloy bars, prepared by the Technical Committee of European Titanium Producers, 1979; Edition 2, 1995, TIG (Titanium Information Group) Unit 34, Middlemore Trading Estate, Smethwick, West Midlands B66 2EE, UK o

49、r TIMET UK, PO Box 704 Witton, Birmingham B6 7UR, UK 2 Titanium in Medicine, (editors D.M.Brunette, P.Tangvall, M.Textor, P.Thompson), Chapter 3, FREESE, H.L., VOLAS, M.G., WOOD, J.R.; Chapter 23, PERREN, S.M., POHLER, O.E.M., SCHNEIDER, E. 2001, Springer Berlin Heidelberg New York, ISBN: 3-540-66936-1 3 ISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy 4 ISO 5832-11, Impl

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