ASTM F543-17 Axial and Torsion Testing of 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 a bone screw as it's implanted within the body. Manufacturers and scientists test bone screws to determine various mechanical properties in order to evaluate new materials and designs.
In ASTM F543-17, there are four testing annexes. Annex A1 requires the screw to be sufficiently clamped and for a rotational velocity between 1 and 5 rpm to be applied until specimen failure. This annex also requires that the torque profile and rotation angle be measured. Annex A2 is designated to measure the torque required to insert and remove the screw with a constant rotational velocity between 1 and 5 rpm, while maintaining an axial load of no more than 10 N in compression. The third annex, Annex A3, specifies a test to measure the force required to axially remove the screw that has been fully inserted in the test block using the method from Test A2. The screw should be loaded in a tensile test at a constant rate of 5 mm/min until failure of the bone screw, or removal from the test block. Finally, Annex A4, specifies a test method for testing self-tapping bone screws. The procedure evaluates the axial loading required to engage a self-tapping bone screw into a standard laboratory material. Although the self-tap action is considered a simple clinical procedure, reproduction of this in the laboratory involves a relatively complex motion. The test requires a continuous rotational velocity of up to 30 rpm, while the axial load is incremented during the insertion at a rate of 2 N/s. The objective of this test is to record the torque profile as the bone screw is inserted into the material and then removed.
The challenges of testing bone screws to this standard are:
- Determining what type of a biaxial system is right for your needs
- Low torque and force measurement
- Instron offers three systems capable of testing bone screws, which include the MT Series torsion only systems, the Torsion Add-On 2.0 for 5900 and 6800 Series table model systems, as well as the ElectroPuls™ Linear Torsion systems.
- When testing to Annex A1, either the MT Series torsion only systems, the Torsion Add-On 2.0 systems, or the ElectroPuls Linear Torsion systems are recommended.
- When testing to Annex A2, Annex A3, or Annex A4, either the Torsion Add-On 2.0 systems or the ElectroPuls Linear Torsion systems are recommended. For laboratories testing a variety of orthopedic devices, the ElectroPuls E3000 or E10000 Linear Torsion systems may be more advantageous as these system are designed to perform fatigue testing. The Torsion Add-On 2.0 systems are controlled with Bluehill® Universal software, while the ElectroPuls Linear Torsion systems utilize WaveMatrix software.
- Low force and torque measurements are capable with Instron’s biaxial Dynacell technology, which can be used on the 5900 Series, 6800 Series, and ElectroPuls Linear Torsion systems.
The Instron Torsion Add-On 3.0 for Electromechanical Universal Testing Systems is designed for simple, simultaneous axial and torsional testing of devices and/or components. Torsion Add-On 3.0 easily mounts to any new or existing Instron 6800 or 5900 system, adding torsion capability to your lab while saving valuable lab space. It utilizes Bluehill Universal’s dedicated axial-torsion and method types in a user-friendly and intuitive interface.
- 2.2 MB
Instron 6800 Series Universal Testing Systems provide unparalleled accuracy and reliability. Built on a patent-pending Operator Protect system architecture with an all-new Smart-Close Air Kit and Collision Mitigation features, the 6800 Series makes materials testing simpler, smarter, and safer than ever before.
- 3.2 MB
5900 Universal Testing Systems are engineered for precision, built for durability, and offer the flexibility for changing requirements. They are designed with standard and optional features that increase testing efficiency and improve the testing experience for the operator. A wide range of models are available for testing capacities from < 100N up to 600kN.
- 6.8 MB
Bluehill Universal Software is built from the ground-up for touch interaction and an intuitive user experience. Discover simpler and smarter testing with features such as pre-loaded test methods, QuickTest in seconds, enhanced data exporting: and Instron Connect – a new feature that provides a direct communication link to Service. Users of previous versions of software such as Bluehill 2 and Bluehill 3 can easily upgrade to the newest version of Bluehill.
- 4.4 MB
The preferred solution for low-force torsion testing and component in-service simulation, the MT MicroTorsion systems are available in two standard models with force capacities up to 225 N-m (2,000 lbf-in). The compact design requires minimal lab space and offers superior frame stiffness and alignment. Packaged with Instron high-performance control electronics, the MT Series provides highly accurate test data and control for testing a product portfolio that includes wire, fasteners, switches, and springs used in the biomedical, automotive, and aerospace industries. The system includes an integrated guard and safety control system that meets the stringent requirements for the European CE mark.
- 0.5 MB
ElectroPuls instruments are state-of-the-art electrodynamic test systems for dynamic and static tests on materials & components. Powered entirely from a single-phase mains supply, they feature the latest in testing technology and a host of other user-oriented features.
- 1.7 MB
The ElectroPulsTM E3000 Linear-Torsion is a state-of-the-art, all-electric test instrument designed for dynamic and static testing on a wide range of materials and components. It includes Instron® advanced digital control electronics, bi-axial DynacellTM load cell, Console software, and the very latest in testing technology – hassle-free tuning based on specimen stiffness, electrically operated crosshead lifts, a T-slot table for flexible test set ups and a host of other user-orientated features. Powered from a single-phase supply it requires no additional utilities for basic machine operation (for example, pneumatic air, hydraulics, or water).
- 0.7 MB
The ElectroPulsTM E10000 is a state-of-the-art, all-electric test instrument designed for dynamic and static testing on a wide range of materials and components. It includes Instron® advanced digital control electronics, bi-axial DynacellTM load cell, Console software, and the very latest in testing technology – hassle-free tuning based on specimen stiffness, electrically operated crosshead lifts, a T-slot table for flexible test set ups and a host of other user-orientated features. Powered from a single-phase supply it requires no additional utilities for basic machine operation (for example, pneumatic air, hydraulics, or water).
- 0.8 MB