ISO 18192-3:2017

Implants 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 conditions

ISO 18192-3:2017 defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions.

Implants chirurgicaux — Usure des prothèses totales de remplacement des disques intervertébraux lombaires — Partie 3: Essai d'incidence d'usure et conditions environnementales correspondantes pour l'essai de prothèses lombaires sous conditions cinématiques défavorables

General Information

• Status: Published
• Publication Date: 11-Jun-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Drafting Committee: ISO/TC 150/SC 5/WG 2 - Spinal devices
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 21-May-2024

Relations

• Consolidated By: ISO 22125-1:2019 - Water quality — Technetium-99 — Part 1: Test method using liquid scintillation counting
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18192-3
First edition
2017-06
Implants 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
conditions
Implants chirurgicaux — Usure des prothèses totales de
remplacement des disques intervertébraux lombaires —
Partie 3: Essai d’incidence d’usure et conditions environnementales
correspondantes pour l’essai de prothèses lombaires sous conditions
cinématiques défavorables
Reference number
ISO 18192-3:2017(E)
©
ISO 2017

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ISO 18192-3:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All 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 prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. [phone]
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www.iso.org
ii © ISO 2017 – All rights reserved

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ISO 18192-3:2017(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Reagents and materials . 2
6 Apparatus . 3
7 Impingement wear testing methods . 5
7.1 General . 5
7.2 Example of development of load and displacement profiles for extension
impingement protocol . 6
7.3 Procedure . 7
8 Test report . 8
9 Disposal of test specimen . 9
Annex A (normative) Wear of spinal disc prostheses — Gravimetric measurement method .10
Annex B (informative) Justification of the test method .13
Bibliography .15
© ISO 2017 – All rights reserved iii

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ISO 18192-3:2017(E)

Foreword
ISO (the International Organization for Standardizatio
...

INTERNATIONAL STANDARD
Deleted: TC /SC N ¶
¶
ISO/FDIS 18192‐3¶
ISO
Voting begins on:¶
2017‐02‐14¶
18192-3
Voting terminates on:¶
2017‐04‐11¶
First edition TC /SC /WG 2¶
Secretariat: ¶
¶
2017-06

Implants 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 conditions
Implants chirurgicaux — Usure des prothèses totales de remplacement des disques
intervertébraux lombaires —
Partie 3: Essai d’incidence d’usure et conditions environnementales correspondantes
pour l’essai de prothèses lombaires sous conditions cinématiques défavorables

Document type:
Document subtype:
Document stage:
Document language:

D:\temp\macroserver\DOCX2PDFRGB\DOCX2PDFRGB.hamaoka@RHAMAOKA_97\C067605e_trackch
anges.docx

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ISO/TC 150/SC 5 N
Contents Page
Foreword . 3
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Reagents and materials . 2
6 Apparatus . 3
7 Impingement wear testing methods . 5
7.1 General . 5
7.2 Example of development of a load and displacement profiles for extension
impingement protocol . 6
7.3 Procedure . 7
8 Test report . 8
9 Disposal of test specimen . 9
Annex A (normative) Wear of spinal disc prostheses — Gravimetric measurement method . 10
A.1 General . 10
A.2 Procedure . 10
A.2.1 Principle . 10
A.2.2 Reagents and materials . 10
A.2.3 Apparatus . 10
A.2.4 Preparation of test specimen for gravimetric measurements . 10
A.2.5 Procedure for gravimetric measurement . 11
Annex B (informative) Justification of the test method . 13
B.1 Background . 13
B.2 Clinical motivation . 13
Bibliography .
...