Standard Specification for Metallic Bone Plates
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 Corp to make sure that your products adhere to ASTM 382 standards in order to submit for FDA approval.
We specialize in testing for a wide variety of different medical devices including Metallic Bone Plates and can ensure that your products are proven to be reliable, according to ASTM F382. Contact us now to schedule a consultation with our expert team, or continue reading for more information about metallic bone plate testing at Empirical Technologies Corp.
ASTM F382 Testing
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.
There are two types of ASTM F382 metallic bone plate testing used for Metallic Bone Plates, as follows:
Single Cycle Bend Testing of Metallic Bone Plates –
- This test involves loading a Metallic Bone Plate into the testing fixture. Its long axis is aligned so that it’s perpendicular to the axes of the loading rollers. Then, loads of increasing magnitude are applied to the bone plate to bend and deform it, and test its strength.
- Information like bending strength, bending stiffness, 2% offset displacement, and bending structural stiffness are recorded after each test to determine the total strength of the Metallic Bone Plate, and its overall resistance to bending and deformation.
Bending Fatigue Properties of Metallic Bone Plates –
- This method is similar to the previous testing method. But rather than using a large load to intentionally deform the Metallic Bone Plate, this test uses multiple bend cycles to simulate fatigue and bending over a longer period of time.
- The Metallic Bone Plate is loaded into the testing device, which is set to apply a certain load directly to the plate for a specified number of cycles – up to 5 million cycles, in some cases. The test is over once the specimen breaks, or the total cycle count has reached the runout limit.
- During this test, data like the maximum moment, failure mode, failure location, and the total number of cycles undergone at test termination will be recorded.
At Empirical Technologies Corp., 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.
Contact Empirical Technologies Corp. to Request an Estimate
At Empirical Technologies Corp., 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.
So don’t wait! If you’re ready to get started with metallic bone plate testing, contact us or give us a call at +1 719.457.1144 to speak with one of our testing professionals. We can discuss ASTM F382 testing in more detail and give you the assistance you need.