ISO-18192-1-2008.pdf
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1、 Reference number ISO 18192-1:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 18192-1 First edition 2008-01-15 Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test Implant
2、s chirurgicaux Usure des prothses totales de remplacement des disques intervertbraux lombaires Partie 1: Paramtres de charge et de dplacement pour essais dusure et conditions environnementales correspondantes Copyright International Organization for Standardization Provided by IHS under license with
3、 ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:08:36 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 18192-1:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file
4、 may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat a
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6、 the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may b
7、e reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing 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. +
8、41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2008 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02
9、/16/2008 04:08:36 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 18192-1:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv 1 Scope 1 2 Normative references1 3 Terms and definitions .1 4 Principle2 5 Reagents and materials 3 5.1 Fluid test medium3 5.2 T
10、est and control specimen.3 6 Apparatus .4 6.1 Testing machine.4 6.2 Means of mounting and enclosing the test specimen.7 6.3 Means of aligning and positioning.7 6.4 Motion control system 8 6.5 Force control system 8 6.6 Lubrication system8 6.7 Temperature control system 8 6.8 Control station(s).8 7 P
11、rocedure .8 8 Test report9 9 Disposal of test specimen 10 Annex A (informative) Statement of rationale for test methods.11 Annex B (informative) Load and displacement data for cervical implants .12 Annex C (informative) Load and displacement data for lumbar implants.13 Annex D (informative) Alternat
12、ive loading conditions 14 Bibliography25 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:08:36 MSTNo reproduction or networking permitted without license from IHS -,-,- IS
13、O 18192-1:2008(E) iv ISO 2008 All rights reserved Foreword ISO (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 committees. Each
14、 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 Internationa
15、l 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. The main task of technical committees is to prepare International Standards. Draft International Standards
16、 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 vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of
17、 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18192-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices. ISO 18192 consists of the following parts, under the general title
18、Implants for surgery Wear of total intervertebral spinal disc prostheses: Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Empl
19、oyees/1111111001, User=Japan, IHS Not for Resale, 02/16/2008 04:08:36 MSTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 18192-1:2008(E) ISO 2008 All rights reserved 1 Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: L
20、oading and displacement parameters for wear testing and corresponding environmental conditions for test 1 Scope This part of ISO 18192 defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of tes
21、ting, sample configuration and test environment to be used for the wear testing of total intervertebral spinal disc prostheses. Both lumbar and cervical prostheses are addressed. This part of ISO 18192 does not address partial disc replacements, such as nucleus replacements or facet joint replacemen
22、ts. The test method focuses on wear testing. Additional mechanical tests such as fatigue testing can be required. This part of ISO 18192 does not reproduce the complex in vivo loads and motions. The wear data obtained with this test method will enable comparison between different types of implants b
23、ut can differ from the clinical wear performance. The user of this part of ISO 18192 should consider running additional wear tests addressing specific safety issues of the individual implant design to be tested. 2 Normative references The following referenced documents are indispensable for the appl
24、ication 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 14242-2, Implants for surgery Wear of total hip-joint prostheses Part 2: Methods of measurement 3 Terms and de
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