BS-ISO-5832-12-2007.pdf
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1、BS ISO 5832-12:2007 ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium- molybdenum alloy Incorporating corrigendum September 2008 Licensed CopyChinese University of Hong Kong,
2、13/06/2009 08:38, Uncontrolled Copy, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 200 Amendments/corrigenda issued since publication DateComments BS ISO 5832-12:2007 National foreword The UK participation in its preparation was
3、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. Users are responsible for its correc
4、t application. Compliance with a British Standard cannot confer immunity from legal obligations. Implementation of ISO corrigendum September 2008. Correction to Table 2, column 2, row 4 BSI 2009 This British Standard is the UK implementation of ISO 5832-12:2007 incorporating corrigendum September 20
5、08. It supersedes ISBN 978 0 580 65647 7 , 31 May 2009 BS 7252-12:1997 which is withdrawn. May9 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:38, Uncontrolled Copy, (c) BSI BS ISO 5832-12:2007 Reference number ISO 5832-12:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 5832-12 Second editi
6、on 2007-05-01 Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy Implants chirurgicaux Matriaux mtalliques Partie 12: Alliage corroy base de cobalt, de chrome et de molybdne Licensed CopyChinese University of Hong Kong, 13/06/2009 08:38, Uncontrolled Copy, (c)
7、BSI BS ISO 5832-12:2007 ISO 5832-12:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, 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 perfor
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10、cretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in wr
11、iting 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 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reserved License
12、d CopyChinese University of Hong Kong, 13/06/2009 08:38, Uncontrolled Copy, (c) BSI BS ISO 5832-12:2007 ISO 5832-12:2007(E) ISO 2007 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). T
13、he 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, governmental and non-go
14、vernmental, 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 the ISO/IEC Directives, Part 2.
15、 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 the member bodies casting a v
16、ote. 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 5832-12 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee S
17、C 1, Materials. This second edition cancels and replaces the first edition (ISO 5832-12:1996), 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 Par
18、t 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-chromium-molybdenum alloy Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy Part 8: Wro
19、ught 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-molybdenum alloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy Licensed CopyChinese
20、University of Hong Kong, 13/06/2009 08:38, Uncontrolled Copy, (c) BSI BS ISO 5832-12:2007 ISO 5832-12:2007(E) iv ISO 2007 All rights reserved Introduction No known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long-term clinical ex
21、perience 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. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:38, Uncontrolled Copy, (c) BSI BS ISO
22、5832-12:2007 INTERNATIONAL STANDARD ISO 5832-12:2007(E) ISO 2007 All rights reserved 1 Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy 1 Scope This part of ISO 5832 covers the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgi
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- BS ISO 5832 12 2007
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