1. Scope
This work item will cover test methods for characterizing the static and dynamic behavior of total disc replacements under worst case loading conditions that can result in impingement damage modalities for LUMBAR total disc replacements.
This guidance will be used by device manufacturers and regulatory agencies to assess the safety and effectiveness of lumbar total disc replacements under worst case loading conditions that can result in impingement damage modalities to these kinds of devices. End users will be device manufactures, regulatory agencies and third party test labs and consultants.
Keywords
Total Disc Replacement (TDR), Total Disc Arthroplasty, Impingement, Wear Testing
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
[Back to Top]
