Standard
ISO 14879-1
Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays
Specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia.
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!
