1、BS ISO 14243-2:2016Implants for surgery Wear oftotal knee-joint prosthesesPart 2: Methods of measurementBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 14243-2:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 14243-2:
2、2016. It supersedes BS ISO 14243-2:2009 which is withdrawn.The UK participation in its preparation was entrusted to Tech-nical Committee CH/150/4, Surgical Implants - Bone and Joint Replacements.A list of organizations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 request to its secretary.This pu
3、blication 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 92016 5 ICS 11.040.40 Compliance with a British Standard cannot confer imm
4、unity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 14243-2:2016 ISO 2016Implants for surgery Wear of total knee-joint
5、 prostheses Part 2: Methods of measurementImplants chirurgicaux Usure des prothses totales de larticulation du genou Partie 2: Mthodes de mesureINTERNATIONAL STANDARDISO14243-2Third edition2016-09-01Reference numberISO 14243-2:2016(E)BS ISO 14243-2:2016ISO 14243-2:2016(E)ii ISO 2016 All rights reser
6、vedCOPYRIGHT 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 or mechanical, including photocopying, or posting on the internet or an intra
7、net, 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, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.i
8、so.orgBS ISO 14243-2:2016ISO 14243-2:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Gravimetric method 14.1 Principle 14.2 Reagents and materials . 14.3 Apparatus 24.4 Test and control specimens 24.5 Preparation of test and control specimens for gravimetric measure
9、ments (pre-soak conditioning) . 24.6 Procedure for gravimetric measurement. 35 Test report . 3 ISO 2016 All rights reserved iiiContents PageBS ISO 14243-2:2016ISO 14243-2:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (I
10、SO 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 organizations, gov
11、ernmental 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.The procedures used to develop this document and those intended for its further mainte
12、nance are described in the ISO/IEC Directives, Part 1. 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 (see www.iso.org/directives). Atten
13、tion 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. Details of any patent rights identified during the development of the document will be in the Introduction
14、 and/or on the ISO list of patent declarations received (see www.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 conformi
15、ty assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint repl
16、acements.This third edition cancels and replaces the second edition (ISO 14243-2:2009), of which it constitutes a minor revision.ISO 14243 consists of the following parts, under the general title Implants for surgery Wear of total knee-joint prostheses: Part 1: Loading and displacement parameters fo
17、r wear-testing machines with load control and corresponding environmental conditions for test Part 2: Methods of measurement Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for testThe following parts are unde
18、r preparation Part 5: Loading and displacement parameters for testing machines and corresponding environmental conditions when testing durability performance of the patellofemoral jointiv ISO 2016 All rights reservedBS ISO 14243-2:2016INTERNATIONAL STANDARD ISO 14243-2:2016(E)Implants for surgery We
19、ar of total knee-joint prostheses Part 2: Methods of measurement1 ScopeThis part of ISO 14243 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243-1 or ISO 14243-3 as appropr
20、iate.2 Normative referencesThe 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 undated references, the latest edition of the referenced document (including any a
21、mendments) applies.ISO 14243-1, Implants for surgery Wear of total knee-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for testISO 14243-3, Implants for surgery Wear of total knee-joint prostheses Pa
22、rt 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1wearmaterial loss from components of the prosthetic
23、joint due to combined movement and loading4 Gravimetric method4.1 PrincipleThe test specimen is soaked in a lubricant. It is repeatedly removed from the lubricant, cleaned, dried and weighed until a steady rate of fluid sorption is established. The test specimen is assessed subsequently for wear by
24、testing for loss in mass in a knee-joint simulator. A loaded or unloaded, non-articulating control specimen submerged in the same lubricating fluid medium is intended to allow for fluid sorption and undergoes the same procedure for reference purposes.4.2 Reagents and materials4.2.1 Fluid test medium
25、, in accordance with ISO 14243-1 or ISO 14243-3 as appropriate.4.2.2 Propan-2-ol. ISO 2016 All rights reserved 1BS ISO 14243-2:2016ISO 14243-2:2016(E)4.3 Apparatus4.3.1 Balance, with an accuracy of 0,1 mg, of sufficient capacity for the mass of the test specimen.4.3.2 Ultrasonic cleaner.4.3.3 Vacuum
26、 drying system, capable of achieving a vacuum of at least 13,33 Pa (100 milliTorr).4.3.4 Filtered inert-gas jet, e.g. nitrogen.4.4 Test and control specimens4.4.1 Test specimen, conforming to ISO 14243-1 or ISO 14243-3 as appropriate.4.4.2 Control specimen, conforming to ISO 14243-1 or ISO 14243-3 a
27、s appropriate.4.5 Preparation of test and control specimens for gravimetric measurements (pre-soak conditioning)4.5.1 Soak the test specimen and control specimen in the fluid test medium (4.2.1) for 48 h 4 h.4.5.2 Remove the test specimen and control specimen from the fluid test medium (4.2.1) and c
28、lean in the ultrasonic cleaner (4.3.2).A typical cleaning regime in the ultrasonic cleaner is as follows:a) vibrate for 10 min in deionized water;b) rinse in deionized water;c) vibrate for 10 min in a mixture of ultrasonic cleaning detergent at the concentration recommended by the detergent manufact
29、urer;d) rinse in deionized water;e) vibrate for 10 min in deionized water;f) rinse in deionized water;g) vibrate for 3 min in deionized water;h) rinse in deionized water;i) dry in a vacuum drying chamber (4.3.3).Care should be taken to avoid abrasion in the ultrasonic cleaner which could lead to a c
30、hange in mass.4.5.3 Dry the test specimen and control specimen with a jet of filtered inert gas (4.3.4).4.5.4 Soak the test specimen and control specimen in propan-2-ol (4.2.3) for 5 min 15 s.4.5.5 Dry the test specimen and control specimen with a jet of filtered inert gas (4.3.4), then dry further
31、in a vacuum of at least 13,3 Pa for at least 30 min.4.5.6 Weigh the test specimen and control specimen on the balance twice in rotation within 90 min of removal from the vacuum. If the two readings per specimen do not agree within 0,1 mg, continue taking 2 ISO 2016 All rights reservedBS ISO 14243-2:
32、2016ISO 14243-2:2016(E)readings in rotation until at least two readings per specimen agree within 0,1 mg. Store the test specimen and control specimen in a sealed dust-free container between weighings.4.5.7 Repeat 4.5.2 to 4.5.6 at intervals until the incremental mass change of the specimen over 24
33、h is less than 10 % of the previous cumulative mass change.4.5.8 Record the average increase in mass S of the control specimen.4.5.9 Take photographic records of all the articulation and fixation surfaces of the specimen. Mark the test sample with reference points so that after the wear test the loc
34、ation of the worn surfaces can be identified relative to the axes of the test sample.4.6 Procedure for gravimetric measurement4.6.1 Mount the test specimens in the testing machine and conduct the wear test in accordance with ISO 14243-1 or ISO 14243-3 as appropriate.4.6.2 Record the mass of the spec
35、imens.4.6.3 On each occasion when the test specimen and control specimen are removed from the wear-testing machine, repeat the procedures in 4.5.2 to 4.5.6, 4.6.1 and 4.6.2.4.6.4 Calculate the gravimetric wear as shown in Formula (1):Wn= Wan+ Sn(1)whereWnis the net mass loss after n cycles of loadin
36、g;Wanis the average uncorrected mass loss;Snis the average increase in mass of the control specimen over the same period.4.6.5 Calculate the average wear rate aGusing Formula (2) for the least-squares linear fit relationship between Wnand the number of loading cycles n:Wn = aGn + b (2)where Wnis the
37、 net loss in mass after n cycles and b is a constant.The zero time point shall not be used in this calculation.4.6.6 Take photographic records of the articulating and fixation surfaces.5 Test reportThe test report shall include the following information:a) a reference to this part of ISO 14243, i.e.
38、 ISO 14243-2,b) the identity of the test specimens, as stated by the party submitting the specimen for test;c) the method of wear measurement (i.e. gravimetric); ISO 2016 All rights reserved 3BS ISO 14243-2:2016ISO 14243-2:2016(E)d) the value Wnfor each measurement using the gravimetric method;e) th
39、e wear rate, aG;f) a reference to the wear test method used from ISO 14243-1 or ISO 14243-3 as appropriate;g) photographic records.4 ISO 2016 All rights reservedBS ISO 14243-2:2016BS ISO 14243-2:2016ISO 14243-2:2016(E) ISO 2016 All rights reservedICS 11.040.40Price based on 4 pagesThis page delibera
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