Standard Specifications for Knee Devices
This standard describes the generic types of knee devices including total knee replacements (TKR) and unicondylar knee replacements (UKR) for both fixed and mobile bearing varieties, and for primary and revision surgeries. The OIC can perform the various test methods referenced in this standard to assess knee device performance, such as: ASTM F1800, ASTM F2777, ASTM F1223, ASTM F2724, ASTM F1814, ASTM F2722, ASTM F2723, and ISO 14243-1/-3. The standard also includes contact area and contact pressure distribution testing to examine the area and magnitude of stresses applied between the femoral component and tibial insert of a total knee replacement at various flexion angles through mapping on pressure films.
