The Applied Technical Services Family of Companies (FoC) evaluates the mechanical performance of metallic bone plates in compliance with the ASTM F3437 standard. Orthopedic surgeons use metallic bone plates to stabilize and align bone fractures, helping to ensure that the fracture has the structural support needed to heal properly. Our medical device testing laboratory helps manufacturers develop and improve their products as they prepare them for the market.
What is ASTM F3437?
The American Society of Testing and Materials developed the ASTM F3437 standard to guide technicians conducting static tests on small bone metallic plates designed for fracture fixation. The objective of the standard is to compare the mechanical performance of various small plates in vitro. The small plates referenced in the standard are for small bone systems, which consist of the following areas:
- Fingers
- Toes
- Upper face
- Cranium
The information gathered during the process provides critical insight into the metallic plate’s durability, reliability, and strength. The standard effectively determines whether a plate is suited for its intended anatomical application.
More About Our Medical Device Tests
The ATS FoC operates multiple A2LA-accredited medical device testing labs with the state-of-the-art equipment and technology needed to conduct various types of tests, including:
- Axial compression tests
- Fatigue tests
- Life cycle tests
- Shear tests
- Tensile tests
- Torsion tests
Each of these services reveals important information about a product or material’s performance characteristics, which can be invaluable to manufacturers seeking to optimize their product’s performance, longevity, and reliability. Our lab’s services adhere to international standards, and we offer accredited services that are accepted in the US, Europe, Asia, and South America. We have an ongoing relationship with the FDA so we’re always expanding our services and familiarizing ourselves with the latest standards to ensure that we give our customers excellent service that will keep products compliant for years to come.
Why is It Important to Test Metallic Bone Plates?
Metallic bone plates must undergo extensive testing to ensure they offer the stability and durability needed to support injured bones. The ASTM F3437 standard offers an effective and efficient way for manufacturers to vet their designs in a preclinical manner. This allows manufacturers to identify and resolve any weaknesses without putting patients at risk. Inadequate testing could lead to premature plate failure, patient harm or discomfort, and noncompliance-related fines and penalties.
Contact Us
For additional information about our ASTM F3437 services, please contact us at +1 (888) 287-5227 or fill out the request form located on this page.
