Please refer to the ASTM website for the most up to date information on ASTM F382 or visit our Quality Standards page to see additional accredited test standards performed at our certified testing laboratory.
Metallic Bone Plates are essential for repairing a wide variety of fractures in bone and are manufactured by many different medical device companies. If your company is beginning to manufacture metallic bone plates, it’s important to work closely with a company like Empirical Technologies to make sure that your products adhere to ASTM 382 standards in order to submit for FDA approval.
Metallic Bone Plates are pieces of metal used along with bone screws to stabilize and hold fractured pieces of bone in the proper position, allowing for the proper healing, recovery, and restoration of bone function. Commonly used alloys include biocompatible metals like cobalt-chromium, 316L stainless steel, and titanium.
ASTM F382, in particular, is concerned with testing methods for Metallic Bone Plates. It is primarily designed to help determine the maximum force the Metallic Bone Plate can withstand, as well as its endurance and resistance to bending and deformation over time. This testing standard defines both the geometric and performance characteristics of Metallic Bone Plates, using both static and fatigue test methods.
At Empirical Technologies, we use the latest testing devices and advanced methodologies to record precise, accurate, and comprehensive results when testing Metallic Bone Plates. Our team of testing specialists is the best in the business, and we have been providing expert medical testing services for more than 20 years.
At Empirical Technologies, we specialize in metallic bone plate testing. We work closely with individuals, companies, and institutions to test their products, check for ASTM standards compliance, and work to prepare products for FDA submission and approval.