ASTM F382 Metallic Bone Plate Testing

ASTM F382 | Medical Devices and Equipment | Bend Testing

Note that there are slight variations depending on the type of sample selected.

1. Prepare samples as described in the standard.
2. For single cycle bend testing:
   1. Place the bone plate sample in the test fixture and align its long axis so that it is perpendicular to the axes of the loading rollers. Make sure the rollers are in contact with the surface of the bone plate.
   2. Apply loads of increasing magnitude, as described.
   3. Record the load versus load-point displacement curve.
3. For bending fatigue testing:
   1. Prior to testing, determine the load levels that will be applied during fatigue testing.
   2. The two recommended methods for evaluating the fatigue performance of bone plates are: M-N Diagram or the Fatigue Strength Determination.
   3. Place the bone plate sample in the test fixture and align its long axis so that it is perpendicular to the axes of the loading rollers. Make sure the rollers are in contact with the surface of the bone plate and that the applied load is equally shared between the specimen loading points.
   4. Select a cyclic frequency that will not produce strain sensitive affects in the bone plate’s material. The standard frequency is 5 Hz.
   5. Apply loads and continue testing until specimen breaks or the total cycle count reaches the runout limit.
   6. Record the maximum moment, cycle count at test termination, the failure mode, and the failure location.

Calculations:

• Bending Stiffness
• Bending Structural Stiffness
• 2% Offset Displacement
• Bending Strength

ASTM F382 | Medical Devices and Equipment | Bend Testing