>> Implant test

Since the first knee replacement nearly 50 years ago, continuous improvements in design and surgical techniques have led to numerous breakthroughs in technology. Verification testing of these new designs and materials remains as critical as ever to ensuring patient safety throughout the life of the device. 

Befitlab offers both total and partial knee replacement testing services. Common tests include fatigue, wear, contact pressure, constraint, and corrosion testing, along with porous coating evaluation and explant failure analysis.

Knee Constraint Test

ASTM F 1223: Standard Test Method for Determination of Total Knee Replacement Constraint.

Dislocation Mobile Bearing Test

ASTM F 2724: Standard Test Method for Evaluating Mobile Bearing Knee Dislocation.
ISO 14879: Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays.
ISO 21536: Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants.
ASTM F 1800: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

ASTM F 2083: Standard Specification for Total Knee Prosthesis

Petella Specification

ASTM F 1672: Standard Specification for Resurfacing Patellar Prosthesis.

Knee Geometry and surfaces
ISO 7207-1: Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions.
ISO 7207-2: Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastic materials.

ISO 21536: Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants.

Knee Wear Test

ISO 14243-1: Implants for surgery -- Wear of total knee joint prostheses
Part 1:Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for tests.
ISO 14243-2: Implants for surgery -- Wear of total knee joint prostheses Part 2: Methods of measurement.

ISO 14243-3: Implants for surgery — Wear of total knee joint prostheses, Part 3: Loading and displacement parameters for wear testing machines with displacement control and corresponding environmental conditions for test.  

Fatigue Test Under High Flexion

ASTM F2777: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion.

Fatigue Test Baseplate/Bearing Fixation

ASTM F2723: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation.

ASTM F2722: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops.