1、Implants for surgery Wear of total intervertebral spinal disc prosthesesPart 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditionsBS ISO 18192-3:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/0
2、5/2013 15:06 ISO 2017Implants for surgery Wear of total intervertebral spinal disc prostheses Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditionsImplants chirurgicaux Usure des prothses totales de remplacement d
3、es disques intervertbraux lombaires Partie 3: Essai dincidence dusure et conditions environnementales correspondantes pour lessai de prothses lombaires sous conditions cinmatiques dfavorablesINTERNATIONAL STANDARDISO18192-3First edition2017-06Reference numberISO 18192-3:2017(E)National forewordThis
4、British Standard is the UK implementation of ISO 18192-3:2017.The UK participation in its preparation was entrusted to Technical Committee CH/150/5, Surgical Implants - Osteosynthesis and spinal devices.A list of organizations represented on this committee can be obtained on request to its secretary
5、.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 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 89423 7ICS 11.040.40Compliance with a British Standard cannot conf
6、er immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS ISO 18192-3:2017 ISO 2017Implants for surgery Wear of total int
7、ervertebral spinal disc prostheses Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditionsImplants chirurgicaux Usure des prothses totales de remplacement des disques intervertbraux lombaires Partie 3: Essai dincide
8、nce dusure et conditions environnementales correspondantes pour lessai de prothses lombaires sous conditions cinmatiques dfavorablesINTERNATIONAL STANDARDISO18192-3First edition2017-06Reference numberISO 18192-3:2017(E)BS ISO 18192-3:2017ISO 18192-3:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PR
9、OTECTED DOCUMENT ISO 2017, 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 intranet, without pr
10、ior 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.iso.orgBS ISO 18
11、192-3:2017ISO 18192-3:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, 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, inclu
12、ding 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 member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel.
13、+41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgISO 18192-3:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 25 Reagents and materials . 26 Apparatus . 37 Impingement wear testing methods 57.1 General . 57.2 Example of development of load and
14、 displacement profiles for extension impingement protocol 67.3 Procedure 78 Test report . 89 Disposal of test specimen 9Annex A (normative) Wear of spinal disc prostheses Gravimetric measurement method .10Annex B (informative) Justification of the test method .13Bibliography .15 ISO 2017 All rights
15、reserved iiiContents PageBS ISO 18192-3:2017ISO 18192-3:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical comm
16、ittees. 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, also take part in the work. ISO collaborates closely with the
17、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. In particular the different approval criteria needed for the
18、 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).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
19、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 (see www .iso .org/ patents).Any trade name used in this
20、document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trad
21、e Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices.A list of all parts in the ISO 1
22、8192 series can be found on the ISO website.iv ISO 2017 All rights reservedBS ISO 18192-3:2017ISO 18192-3:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards
23、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, also take pa
24、rt 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. In particu
25、lar 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).Attention is drawn to the possibility that some of the elements of t
26、his 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 (see ww
27、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.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as
28、information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis a
29、nd spinal devices.A list of all parts in the ISO 18192 series can be found on the ISO website.iv ISO 2017 All rights reserved INTERNATIONAL STANDARD ISO 18192-3:2017(E)Implants for surgery Wear of total intervertebral spinal disc prostheses Part 3: Impingement-wear testing and corresponding environm
30、ental conditions for test of lumbar prostheses under adverse kinematic conditions1 ScopeThis document defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions.2 Normative referencesThe following documents are referred to in the text in
31、 such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 4965-1, Metallic materials Dynamic force calibra
32、tion for uniaxial fatigue testing Part 1: Testing systemsISO 18192-1, Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for testISO 23788, Metallic materials Verification of
33、 the alignment of fatigue testing machines3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18192-1 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available
34、at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp3.1impingementpoint at which two opposing components collide or restrict motion usually indicated by a sharp change in force or moment3.2range of motionROMamount of angular displacement that
35、 a total disk replacement prosthesis can undergo from the device neutral position to the point at which impingement occurs around a defined global axisNote 1 to entry: If an implant impinges at 15 from the implant neutral position in flexion and 20 from the implant neutral position in extension, the
36、 implant range of motion can be defined as +15/-20 in flexion/extension. ISO 2017 All rights reserved 1BS ISO 18192-3:2017ISO 18192-3:2017(E)3.3distance between centre of rotation and point of impingementDCIdistance between the point of impingement and the nominal centre of rotation for the flexion,
37、 extension or lateral bending motions3.4axial load during impingementALIaxial load applied to the device in newtons while the device is in an impinged condition3.5point of impingementpoint of contact between two opposing components that results in impingement4 PrincipleBased on current clinical evid
38、ence, lumbar spinal disc prostheses have experienced impingement in extension/flexion, lateral bending, axial rotation and combinations thereof with extension being the most commonly reported mode for the lumbar spine.Adverse impingement testing conditions are determined based on available clinical
39、data, engineering analysis and other relevant information in the literature.An axial load and a time-varying angular displacement are applied to the test specimens to simulate repeated contact between design features of the specimens.Four possible individual impingement scenarios have been identifie
40、d in the literature:a) flexion;b) extension;c) lateral bending;d) combined flexion and lateral bending.In addition, combined axial rotation with any of the aforementioned motion modes should be considered, if necessary to achieve a clinically relevant impingement wear scar and/or worst case impingem
41、ent scenario.A load soak control specimen, if polymers are the object of investigation, is subjected to the same time-varying force to determine the creep of the test specimen and/or the amount of mass change due to fluid transfer. The test takes place in a controlled environment simulating physiolo
42、gical conditions.5 Reagents and materials5.1 Fluid test medium.The fluid test medium consisting of calf serum diluted with de-ionized water (balance) to a concentration of 20 g 2 g protein/l shall be prepared according to ISO 18192-1. If routine monitoring of the pH of the fluid test medium is under
43、taken, the values shall be included in the test report see Clause 8, m) 6) as an increase in pH could indicate an increase in microbial activity1.5.2 Test and control specimen.Between the inferior and superior components shall be the articulating surface of the inferior and superior components, atta
44、ched by its normal immediate backing (for example, bone cement or a machined replica of the inner surface of the backing), unless this is impractical due to physical features 2 ISO 2017 All rights reservedBS ISO 18192-3:2017ISO 18192-3:2017(E)3.3distance between centre of rotation and point of impin
45、gementDCIdistance between the point of impingement and the nominal centre of rotation for the flexion, extension or lateral bending motions3.4axial load during impingementALIaxial load applied to the device in newtons while the device is in an impinged condition3.5point of impingementpoint of contac
46、t between two opposing components that results in impingement4 PrincipleBased on current clinical evidence, lumbar spinal disc prostheses have experienced impingement in extension/flexion, lateral bending, axial rotation and combinations thereof with extension being the most commonly reported mode f
47、or the lumbar spine.Adverse impingement testing conditions are determined based on available clinical data, engineering analysis and other relevant information in the literature.An axial load and a time-varying angular displacement are applied to the test specimens to simulate repeated contact betwe
48、en design features of the specimens.Four possible individual impingement scenarios have been identified in the literature:a) flexion;b) extension;c) lateral bending;d) combined flexion and lateral bending.In addition, combined axial rotation with any of the aforementioned motion modes should be cons
49、idered, if necessary to achieve a clinically relevant impingement wear scar and/or worst case impingement scenario.A load soak control specimen, if polymers are the object of investigation, is subjected to the same time-varying force to determine the creep of the test specimen and/or the amount of mass change due to fluid transfer. The test takes place in a controlled environment simulating physiological conditions.5 Reagents and materials5.1 Fluid test medium.The fluid test medium consisting
