ASTM F384 Testing
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ASTM F384 | Medical Devices and Equipment | Bend Testing

ASTM F384 is a testing standard that defines the geometric and performance characteristics of metallic angled devices. This standard covers both static and fatigue test methods to determine the mechanical properties of metallic angled orthopedic fracture fixation devices and covers two test methods:

  • Test Method for Single Cycle Compression Bend Testing of Metallic Angled Orthopedic Fracture Fixation Devices: This method measures the bending stiffness and the bending strength and determines the intrinsic, structural properties of metallic angled fracture fixation devices.
  • Test Method for Determining the Bending Fatigue Properties of Metallic Angled Orthopedic Fracture Fixation Devices: This method may be used to determine the fatigue life of angled devices 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 F384, it is important to read the entire specification in the relevant ASTM publication.

ASTM F384 | Orthopedic Fixation Devices | Mechanical Properties

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. Apply loads of increasing magnitude at the speed recommended in the standard.
    2. 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. Anchor the angled device in the testing fixture and position it so that loads can be applied consistently and the clinical failure mode can be investigated.
    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
  • 2% Offset Displacement
  • Bending Strength

ASTM F384 | Orthopedic Fixation Devices | Mechanical Properties

ASTM F384 Recommended Equipment
Testing System
Fixturing
  • ASTM F384 Fixture
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