BS ISO 18192-2:2010
Current
The latest, up-to-date edition.
Implants for surgery. Wear of total intervertebral spinal disc prostheses Nucleus replacements
Hardcopy , PDF
English
31-07-2010
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Reagents and materials
6 Apparatus
7 Cycle limit
8 Procedure
9 Test report
10 Disposal of test specimen
Annex A (informative) - Statement of rationale for test methods
Bibliography
Describes a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192-1.
| Committee |
CH/150/5
|
| DevelopmentNote |
Supersedes 09/30196537 DC. (07/2010)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
This part of ISO18192 defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO18192-1.
This part of ISO18192 is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint replacements. The method includes wear and fatigue testing. Additional mechanical tests such as creep tests can be required.
Thispart of ISO18192 does not reproduce the complex in vivo loads and motions. The wear and fatigue data obtained with this test method will enable comparison between different types of implant but can differ from the clinical wear performance. The user of this part of ISO18192 should consider running additional tests addressing specific safety issues of the individual implant design to be tested.
| Standards | Relationship |
| ISO 18192-2:2010 | Identical |
| ISO 18192-1:2011 | 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 |
| ISO 14242-2:2016 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
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