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ASTM F382 | Medical Devices and Equipment | Bend Testing

ASTM F382 is a testing standard that defines the geometric and performance characteristics of metallic bone plates. This standard covers both static and fatigue test methods to determine the mechanical properties of bone plates and covers two test methods:

  • Test Method for Single Cycle Bend Testing of Metallic Bone Plates: This method measures the bending stiffness, bending structural stiffness, and bending strength and determines the intrinsic, structural properties of metallic bone plates.
  • Test Method for Determining the Bending Fatigue Properties of Metallic Bone Plates: This method may be used to determine the fatigue life of bone plates at a specific or over a range of maximum bending levels, or to estimate the fatigue strength for a specified number of cycles.

These tests require a testing machine capable of both static and dynamic testing. ADMET’s eXpert 5953 Static and Dynamic Bone Plate Testing System is capable of performing the two test methods outlined in this standard. Before conducting ASTM F382, it is important to read the entire specification in the relevant ASTM publication.

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

ASTM F382 Recommended Equipment
Testing System
Fixturing
  • ASTM F382 Bend Fixture with Floating Rollers
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