ASTM F2193 encompasses varied test annexes to perform determining the strength, stiffness, and durability of spinal screws.
ADMET’s eXpert 2600 will perfom the following tests:
- A1 Metallic Spinal Screws: Describes the specification for metallic spinal screws. The Classification, Marking, Packaging, Labeling, and Handling as well as a variety of designations that define this specification. For a full listing go to www.astm.org.
- A2 Metallic Spinal Plate Bend Testing Determine Spinal Plate structural stiffness, bending yield moment, bending ultimate moment, bending fatigue runout moment. This annex references ASTM F382 for Fatigue runout and bending moment. MTESTQuattro Torsion is a servo controlled data acquisition, analysis, and reporting PC based control system that will obtain the above data, store, analyze, and generate reports for review.
Configure 4 point bend fixture are in accordance with table below:
| Spinal Location | h(mm) | a(mm) |
| Cervical | 35.00 | 35.00 |
| Thoracic and Lumbar | 76.00 | 76.00 |
STATIC Tests
- Sample size determined by practice E122.
- Load the test specimen at a rate of 10mm/min to failure
- Record max load at failure
FATIGUE Tests
- Apply Sinusoidal cyclic loads in load control at an R ratio of 0.10 for lumbar and thoracic devices and -0.10 for cervical spine regions.
- Frequency up to 30Hz maximum
- determine fatigue maximum moment levels from static test. 25, 50, and 75% of bending ultimate moment.
A3 Metallic Spinal Rods
Determine Spinal Rod’s bending structural stiffness, bending yield moment, bending ultimate moment, bending fatigue runout moment, and bending fatigue according to ASTM F382.
STATIC Tests
- Using “V” Notched Roller for the top of the fixture, apply axial load at a rate of 10mm/min until failure.
FATIGUE Tests
- Same as A2.
A4- Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws
Determines characteristics of the spinal screws needed for procedures and not the performance of the spinal screws. Prepare apparatus according to Figure 4.2- www.ASTM.org
STATIC Test
- Use ADMET eXpert 2600 constant displacement rate- apply tensile or compressive load. Use MTESTQuattro for profile set up, realtime xy plot, analysis bending/stiffness and more.
- Apply loads of increasing magnitude and generate load vs. displacement curve at a rate of 25mm/min.
- When load changes sign, beyond the linear elastic region, end the test.
- Record failure load at failure and comment.
FATIGUE Test
- same as A2
More detail included in full specification found at www.astm.org
Custom fixtures available upon request.
All ADMET testing systems come with free lifetime technical support and free startup online training. 1-800-667-3220
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Medical Device and Material Testing
ADMET 1-800-667-3220 www.ADMET.com
