ASTM F543 Metallic Medical Bone Screw Testing

The Applied Technical Services Family of Companies (FoC) evaluates bone screws in accordance with ASTM F543 metallic medical bone screw testing standards. Metallic bone screws are internal fixation devices that secure medical devices such as implants and plates to the skeletal system. Bone screws require significant testing and evaluation before clinical use. Our medical device testing lab has the resources to assist clients as they qualify their products for the marketplace.
ASTM F543 Metallic Medical Bone Screw Testing
The American Society for Testing and Materials established ASTM F543 as the definitive standard for metallic medical bone screw testing. ASTM F543 is organized into the following four sections.

Annex 1

Annex 1 evaluates the uniformity of bone screws, allowing technicians to compare various bone screws to different yet similar products. Annex 1 measures the breaking angle, maximum torque, and torsional yield strength of bone screws.

Annex 2

Annex 2 measures the torque needed to drive a bone screw in a bone-like material, ensuring that screws are easily insertable during orthopedic surgery.

Annex 3

Annex 3 measures the force required to remove a bone screw from its application.

Annex 4

Annex 4 measures the axial compression force needed for the self-tapping feature in some bone screws.
Our Commitment to Quality
The Applied Technical Services Family of Companies (FoC) is an esteemed and well-established enterprise specializing in consulting engineering, inspection, and testing services. Since our founding in 1967, we’ve maintained a customer service-centered culture where we provide our customers with the following:
Our medical device testing labs help clients develop products that adhere to FDA regulations and improve public health. Our lab professionals work closely with clients to evaluate their products, ensuring reliability, safety, and performance. Please call +1 (888) 287-5227 or submit a web request to inquire about our ASTM F543 metallic bone screw testing services.

Request Form

Medical Device Testing