BS ISO 7206-6-2013 en_7880 Implants for surgery Partial and total hip joint prostheses Endurance properties testing and performance requirements of neck region of stemmed femoral components《.pdf
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1、BSI Standards Publication BS ISO 7206-6:2013 Implants for surgery Partial and total hip joint prostheses Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral componentsBS ISO 7206-6:2013 BRITISH STANDARD National foreword This British Standard is the UK
2、 implementation of ISO 7206-6:2013. It supersedes BS 7251-10:1992 which is withdrawn. The UK participation in its preparation was entrusted to Tech- nical Committee CH/150/4, Surgical Implants - Bone and Joint Replacements. A list of organizations represented on this committee can be obtained on req
3、uest to its secretary. 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 2013. Published by BSI Standards Limited 2013 ISBN 978 0 580 66662 9 ICS 11.040.40 Compliance with a Br
4、itish Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2013. Amendments/corrigenda issued since publication Date T e x t a f f e c t e dBS ISO 7206-6:2013 ISO 2013 Implants fo
5、r surgery Partial and total hip joint prostheses Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components Implants chirurgicaux Prothses partielles et totales de larticulation de la hanche Partie 6: Exigences de performance et essais des proprits
6、 dendurance de la rgion du col des tiges fmorales INTERNATIONAL STANDARD ISO 7206-6 Second edition 2013-11-15 Reference number ISO 7206-6:2013(E)BS ISO 7206-6:2013ISO 7206-6:2013(E)ii ISO 2013 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2013 All rights reserved. Unless otherwise specified,
7、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 ISOs mem
8、ber 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 SwitzerlandBS ISO 7206-6:2013ISO 7206-6:2013(E) ISO 2013 All rights reserved iii Contents Page Foreword i
9、v Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Principle of the test method . 2 5 Materials . 2 6 Apparatus . 2 7 Selection of test specimens 3 8 Procedure. 3 8.1 Measurement of the distance (CT) 3 8.2 Definition of the distal stem axis . 3 8.3 Definition of the
10、 proximal stem axis 3 8.4 Specimen positioning 3 8.5 Specimen embedding 4 8.6 Embedding medium hardening 4 8.7 Test conditions 4 8.8 Loading 4 8.9 Frequency 4 8.10 Test end . 4 8.11 Complementary analysis 5 8.12 Test repetition 5 9 Endurance performance . 5 10 Test report . 5 11 Disposal of test spe
11、cimens . 6 Annex A (informative) Examples of specimen orientation . 7 Bibliography .15BS ISO 7206-6:2013ISO 7206-6:2013(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International
12、 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 liaison with ISO, a
13、lso 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 Directives, Part 1
14、. 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. www.iso.org/directives Attention is drawn to the possibility that some of the elements
15、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 declarations received. ww
16、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. The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacements. This second edition cancel
17、s and replaces the first edition (ISO 7206-6:1992), of which it constitutes a minor revision. ISO 7206 consists of the following parts, under the general title Implants for surgery Partial and total hip joint prostheses: Part 1: Classification and designation of dimensions Part 2: Articulating surfa
18、ces made of metallic, ceramic and plastics materials Part 4: Determination of endurance properties and performance of stemmed femoral components Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components Part 10: Determination of resistance to stat
19、ic load of modular femoral headsiv ISO 2013 All rights reservedBS ISO 7206-6:2013ISO 7206-6:2013(E) Introduction The test method described in this part of ISO 7206 is intended for the verification of the endurance properties of the neck region of stemmed femoral components of hip joint prostheses. T
20、his method is based extensively on that given in ISO 7206-4, which verifies the endurance properties of the complete femoral component under loading conditions that include a torsional component. The test conditions in ISO 7206-4, especially the height of the specimen embedding, are intended to repr
21、esent the clinical situation where the prosthesis has become loosened in the femur, whereas the test conditions in this part of ISO 7206 are intended to represent a correctly and firmly fixed prosthesis. Therefore, it should be noted that the tests in this part of ISO 7206 may not be representative
22、of the most unfavourable clinical conditions. ISO 2013 All rights reserved vBS ISO 7206-6:2013BS ISO 7206-6:2013Implants for surgery Partial and total hip joint prostheses Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components 1 Scope This part
23、 of ISO 7206 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. This part of ISO
24、 7206 does not cover the investigation of the performance of the head or the neck-head junction. It is applicable to modular and non-modular designs made of metallic or non-metallic materials. It also specifies the test conditions so that the important parameters that affect the hip femoral componen
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