Standard
ASTM F1357
Standard Specification for Articulating Total Wrist Implants
This specification covers total wrist implants that provide articulation function through radial carpal components. However, this specification does not include implants with ceramic coated or porous coated surfaces, one-piece elastomeric implants, and those used for custom applications. Implants covered by this specification are of the constrained, partially constrained, or unconstrained joint prosthesis type. Tests for…
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!
