ASTM F543 - Axial and Torsional Testing of Metallic Medical Bone Screws
Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F543 is a testing standard used exclusively in the biomedical industry that defines specifications for metallic medical bone screws. Bone screws are used in surgical procedures for securing implants, osteosynthesis devices, and fracture fixation plates to the skeletal system. In normal clinical use, a surgeon applies combined axial and torsional forces to implant a bone screw into the body. Bone screws are designated Class 2 FDA devices, requiring significant testing and analysis of mechanical properties prior to approval and release.
ASTM F543-17 includes multiple annexes which address the properties related to the functional use of bone screws and the axial torsion forces associated with their use. The standard also includes geometric specifications for the design of these devices. The annexes include both purely torsional as well as biaxial testing for a complete evaluation of these devices. To read the standard in full, purchase ASTM F543.
Materials Testing Systems
The axial annexes of ASTM F543 can be performed on a static universal testing system such as Instron's 6800 Series, while the torsional annexes can be performed on a torsion-only system such as Instron's MT Torsion Series. The recent introduction of the Torsion Add-On 3.0 allows both axial and torsional testing to now be performed on a single 6800 Series system.
| ASTM F543 Test Setup | |
|---|---|
| 1) | 6800 Series Universal Testing System |
| 2) | Bluehill Universal Software |
| 3) | Torsion Add-On 3.0 |
| 4) | 2712 Series Side-Action Grip |
| 5) | 2270 Series Biaxial Load Cell |
Grips and Fixtures
ASTM F543 generally requires the use of simulated bone per the standard, which is typically held in place with either side action grips or a customized fixture depending on the geometry of the simulated bone. A drill chuck will hold the screwdriver bit to either engage or disengage the screw. For the axial pull-out test, a custom fixture is needed to grab the head of the screw and pull it out after reaching a predetermined level of thread engagement. A biaxial load cell is needed, with a 1 kN 25 Nm capacity generally being sufficient for this kind of testing.
Catálogo de sistemas de ensayo Serie 6800 Premier
Los sistemas de ensayo universales Serie 6800 de Instron proporcionan una precisión y fiabilidad sin igual. Construida sobre una arquitectura de sistema Operator Protect pendiente de patente, con un kit Smart-Close totalmente nuevo y funciones de mitigación de colisiones, la Serie 6800 hace que los ensayos de materiales sean más sencillos, limpios y seguros que nunca.
Catálogo de Bluehill Universal
El software Bluehill Universal está diseñado desde el principio para una interacción táctil y una experiencia de usuario intuitiva. Descubre ensayos más sencillos y limpios con funciones como métodos de ensayo precargados, QuickTest en segundos, exportación de datos mejorada e Instron Connect, una nueva función que proporciona un enlace de comunicación directa con el servicio. Los usuarios de versiones anteriores del software, como Bluehill 2 y Bluehill 3, pueden actualizarse fácilmente a la última versión de Bluehill.
Complemento de torsión 3.0
El Complemento de torsión 3.0 ofrece una solución sencilla para caracterizar el rendimiento de dispositivos médicos, electrónica, productos de consumo, embalajes y componentes de automoción que requieren ensayos axiales y de torsión.