ASTM F1264 | Medical Devices and Equipment | Mechanical Properties
ASTM F1264 is a standard specification used to characterize the design and mechanical function of intramedullary fixation devices (IMFDs). The specification covers IMFDs for surgical fixation of the skeletal system, in addition to classification, terminology, labeling, and material specifications, it includes four standard test methods: static four-point bend test method (Annex A1), static torsion test method (Annex A2), bending fatigue test method (Annex A3), and the test method for bending fatigue of IMFD locking screws (Annex A4). Before performing these tests, please read the entire specification from the relevant ASTM publication.
ASTM F1264 | Medical Devices and Equipment | Mechanical Properties
Test Procedure for A1 – Static Four-Point Bend Test Method
- Place the prepared IMFD test specimen on the four-point bend fixture.
- Apply compressive loading at a constant displacement rate.
- Record the load vs. displacement curve.
- Bending Strength
- Bending Structural Stiffness
Test Procedure for A2 – Static Torsional Testing of Intramedullary Fixation Devices
- Secure the straight, uniform section of a specified-length IMFD specimen in a torsion system.
- Load the specimen under a pure torsional moment.
- Record the resulting angular deflection and the torque-rotation curve.
Calculation:
- Torsional Stiffness
Test Procedure for A3 – Bending Fatigue Testing of Intramedullary Fixation Devices
- Place the IMFD test specimen on a four-point bend fixture of a fatigue testing system.
- Start a sinusoidal cyclic test at the specified frequency until specimen failure or until a limit or a predetermined number of cycles is reached.
Calculations:
- Fatigue Strength
- Fatigue Life
Test Procedure for A4 – Bending Fatigue Testing of IMFD Locking Screws
- Place the screw specimen on a three-point or four-point bend fixture.
- Start a sinusoidal cyclic test at the specified frequency until specimen failure or until a limit or a predetermined number of cycles is reached.
Calculations:
- Fatigue Strength
- Fatigue Life
ASTM F1264 | Medical Devices and Equipment | Mechanical Properties
| ASTM F1264 | Recommended Equipment |
|---|---|
| Testing System | |
| Fixturing |