Standard Specification for Metallic Medical Bone Screws
Please refer to the ASTM website for the most up to date information on ASTM F543 or visit our Quality Standards page to see additional accredited test standards performed at our certified testing laboratory.
ASTM F543 testing is concerned with the testing of Metallic Medical Bone Screws, which are used alongside Metallic Bone Plates to secure bones and encourage proper healing after major fractures.
Proper testing of Metallic Medical Bone Screws is essential to ensure durability, strength, and biocompatibility that adheres to ASTM F543 medical bone screw testing standards, and to meet FDA requirements. At Empirical Technologies Corp., we can assist individuals and companies of all types and sizes with ASTM F543 testing. Our goal is to fast-track your products to ensure you can reach the market quickly and with minimal complications. Continue reading to learn more or contact us now to set up a consultation.
ASTM F543 Testing
ASTM F543 outlines requirements for Metallic Medical Bone Screw testing related to materials used, marking and finish, dimensions and tolerances, and care and handling for Metallic Bone Screws. In part, it is based on ISO 5835, ISO 6475, and ISO 9268 standards.
This test method helps measure the overall quality and uniformity of tested products, particularly when comparing them to similar Metallic Medical Bone Screws.
There are four primary testing methods outlined in the ASTM F543 testing standard, as follows:
- A1 – This test method is designed to find the breaking angle, maximum torque, and torsional yield strength of the Metallic Medical Bone Screw. The screw will be secured using a collet, and then a drill will be used to drive the specimen screw at the rate outlined in the ASTM F543 medical bone screw testing standard. The results of the test will be measured and cataloged.
- A2 – The A2 test is used to measure the insertion depth, insertion roque, axial load, and removal torque of a Metallic Medical Bone Screw. A test block is placed in a specialized clamping device, and a bone screw is lowered by a spindle into a pilot hole on the test block. Then, the bone screw is driven into the test block using torsional force. The maximum torque during these revolutions will be recorded. Next, the process is reversed. After this, the screw will be rotated in the opposite direction to remove it, and the maximum torque during these revolutions will be recorded.
- A3 – This test is used to determine insertion depth and axial pullout strength. The bone screw is inserted into a test block that is secured into a frame as outlined in ASTM F543 standards. The head of the screw is gripped and subjected to a tensile load of 5 mm per minute. This will only stop once the screw is pulled out of the block or fails completely.
- A4 – This test provides information about axial load, maximum self-tap force, axial displacement, and maximum torque. A test block is clamped in place, and the Metallic Medical Bone Screw is lowered into a pilot hole on the test block and driven at a specified rotational rate. The compression force of the spindle driving the screw will continue to grow until the self-tapping feature of the screw engages and it begins driving into the test block. This load will then be maintained, and the screw will continue to be driven into the test block until a specified number of complete rotations has been achieved.
Contact Empirical Technologies Corp. & Get Started Today
With more than 20 years in the field of medical testing, Empirical has a stellar reputation, and our team of medical device testing experts will work closely with your team to test all of your Metallic Medical Bone Screws and ensure they adhere to ASTM standards.
Not only that, but we work closely with medical device manufacturers to prepare products for FDA submission. Whether your company is changing a current product, bringing a new product to market, or entering the medical device manufacturing field for the first time, our team is here to help. Contact us to get started today.