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 It supersedes BS 7251-10:1992 which is withdrawn.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
25、ts are taken into account and describes how the specimen is set up for testing. 2 Normative references The following 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 undate
26、d references, the latest edition of the referenced document (including any amendments) applies. ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 4965-1:2012, Metallic materials Dynamic force calibration for uniaxial fatigue testing Part 1: Testing systems ISO 496
27、5-2:2012, Metallic materials Dynamic force calibration for uniaxial fatigue testing Part 2: Dynamic calibration device (DCD) instrumentation ISO 7206-1, Implants for surgery Partial and total hip joint prostheses Part 1: Classification and designation of dimensions 3 T erms a nd definiti ons For the
28、 purposes of this document, the terms and definitions given in ISO 7206-1 and the following apply. 3.1 implantable condition of a test sample which has received all the machining processes, cleaning, degreasing, and sterilization procedures required prior to implantation 3.2 resection line/level lev
29、el prescribed by the manufacturer which, in clinical use of the femoral hip stem, corresponds to the proximal cut of the bone shaft INTERNATIONAL ST ANDARD ISO 7206-6:2013(E) ISO 2013 All rights reserved 1BS ISO 7206-6:2013ISO 7206-6:2013(E) 4 Principle of the test method The test specimen is embedd
30、ed in a solid medium. For modular stems, the protruding part of the test specimen is immersed in a fluid test medium. A cyclic load is applied to the head of the test specimen until one of the conditions mentioned in 8.10 occurs. 5 Materials 5.1 Embedding medium, i.e., a casting medium, which shall:
31、 a) not crack or break under the load applied during testing; b) not exhibit excessive deformation or creep; c) be reproducible in strength and other characteristics. The media that appear satisfactory are acrylic bone cement (see ISO 5833), filled epoxy casting resin, and liquid metal as an amorpho
32、us metal alloy. The media should have a modulus of elasticity between 2 000 N/mm 2and 6 000 N/mm 2 . 5.2 Fluid test medium, a 9,0 g/l solution of analytical grade sodium chloride (NaCl) in distilled or deionized water of grade 3, as specified in ISO 3696. 6 Apparatus 6.1 Testing machine, has the fol
33、lowing characteristics: a) ability to apply a cyclic load in accordance with Clause 8, at the chosen frequency; b) tolerance in applied load is not greater than 2 % at maximum load applied, as specified in ISO 4965; c) dynamic loading waveform is sinusoidal at the primary frequency; d) instrumentati
34、on to monitor the values of the maximum and minimum loads and the vertical deflection of the head of the test specimen with an uncertainty lower than 0,4 mm to stop the machine if deflection exceeds a prescribed value and to record the corresponding number of cycles or the elapsed time of operation.
35、 6.2 Specimen holders, has a construction and dimensions to suit the testing machine and test specimens. An example of a suitable holder is shown in Figure A.1. In a few cases (circular or slightly elliptical cross-sections of stem), an additional rotational stabilization may be used. This stabiliza
36、tion should fix only to the distal stem. 6.3 Fluid container, for tests on modular stemmed femoral components where the container surrounding the test specimen is used to contain the test fluid together with a means of heating it. 6.4 Gripping device, used to grip the test specimen by the head or ne
37、ck, which retains the specimen in the orientation specified in 8.4. An example of a suitable device is shown in Figure A.2. 6.5 A means of loading the test specimen, shall be employed which maintains loading through the centre of the head of the specimen, along the axis of the testing machine. It sh
38、all also incorporate a low-friction mechanism that in the horizontal plane minimizes loads not coincident with the axis of the testing machine.2 ISO 2013 All rights reservedBS ISO 7206-6:2013ISO 7206-6:2013(E) 7 Selection of test specimens Six specimens shall be selected and shall be technically equ
39、ivalent to the implantable product. The combination of hip stem, head, and other components to be tested should be the “worst case” expected to produce the highest levels of stress in the neck region of the stem. The technical equivalence of the tested components with the implantable products shall
40、be documented. 8 Procedure 8.1 Measurement of the distance (CT) Measure the distance (CT) between the centre of the head (C) and the most distal point of the stem (T) in accordance with Figures A.3a, A.3b, A.4a, and A.4b. For all stems (i.e. monobloc and modular), a head with a neck length considere
41、d the “worst-case” scenario shall be used for the measurement of the length CT, measurements associated with defining the axis of the distal and proximal stem, orientation of the stem in the potting medium, and testing. 8.2 Definition of the di stal st em axis Define the distal stem axis as the line
42、 (KL) joining the centres of cross sections at distances 0,1 CT and 0,4 CT from the most distal end of the stem (point T) when CT is shorter than 200 mm and 0,1 CT and 0,8 CT when CT is longer than 200 mm, as shown in Table 1. NOTE Femoral stems 200 mm may be shortened to a minimum of 200 mm stem le
43、ngth for embedding after appropriate orientation (as given in Table 1 and Figure A.4: K 0,1 x CT; L 0,8 CT) by using a template. Table 1 K and L distance from the stem tip depending on CT length CT length 200 mm 200 mm K 0,1 CT 0,1 CT L 0,4 CT 0,8 CT 8.3 Definition of the pr o ximal st em axis Defin
44、e the proximal stem axis as the neck or taper axis when this axis is obvious or the line joining the head centre (C) and the centre (M) of the cross sections located 10 mm above the resection line when no taper or neck axis is easily defined. For curved neck stems, the second definition should be pr
45、eferred. 8.4 Specimen positioning Hold the head or neck of the test specimen by means of the gripping device (6.4) and position the specimen so that the distal axis is oriented at angle and the proximal axis is oriented at angle , where = 10 1 and = 9 1 for all stem lengths, as shown in Figures A.3a
46、, A.3b, A.4a, and A.4b. Mount the holder and specimen in the gripping device so that the load line of the testing machine intersects point C of the specimen, as designated in ISO 7206-1. Clamp the holder firmly in position and ensure that the correct orientation of the specimen is maintained. Measur
47、e and record the angles and , as designated in Figures A.3a, A.3b, A.4a, and A.4b. The angles and should be measured between projection of KL axis in two vertical planes and the load line of the test machine. The angle should be measured before angle . It is essential that the neck of the prosthesis
48、 is not marked or damaged during this installation process because damage can affect the endurance properties. Damage to the head of the prosthesis should also be avoided as this can increase the friction between the head and the loading system during testing. ISO 2013 All rights reserved 3BS ISO 72
49、06-6:2013ISO 7206-6:2013(E) For a neck with anteversion or retroversion, the stem shall be rotated around KL axis with an angle corresponding to anteversion or retroversion angle with a tolerance of 1. 8.5 Specimen embedding Embed the specimen in the embedding medium (5.1) in the holder (6.2) so that the embedding medium extends up to the resection level 2 mm (see Figure A.1). Areas of high stress (for example, impaction holes and extraction holes) should no
