Standard
ASTM F2665
Standard Specification for Total Ankle Replacement Prosthesis
This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in-vivo performance of the prosthesis are defined.
Our Testing Services
When choosing a medical device testing laboratory to perform evaluations, there are four key elements to consider:
- Interaction with a senior engineer to review the intricacies of the device and to ensure the proposed testing will address corporate goals and objectives
- Accurate implementation of the testing standard(s)
- Comprehensive reporting of the materials, procedures and data to align with ASTM/ISO and USFDA reporting requirements
- Regularly scheduled and documented verification, calibration and maintenance of testing equipment
ORL does all of the above, always has, and laid the groundwork for many of today’s active standards!
