ASTM F3044 Standard Test Method for Evaluating Galvanic Corrosion Potential for Medical Implants

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ASTM F3044 testing. This test method involves conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact to be used in the human body as medical implants or as component parts of medical implants.

Examples of device types that may be considered include overlapping stents of different alloys, combinations of stent and stent markers, orthopedic plates and screws where one or more screws are of a different alloy from the rest of the device, and multi-piece screws.

Devices that will be partially implanted but are in prolonged contact with the body (such as external fixation devices) can also be evaluated using this method.

This test method covers the selection of samples, sample preparation, test environment, method of exposure, and method of evaluating results to characterize the behavior of galvanic couples in an electrolyte.

Devices and device components are designed to be tested in their finished condition as they will be implanted (ie, the metallurgical and surface condition should be in the same condition as, or as close as possible, to the finished device).

This test method does not address other corrosion and degradation damage that may occur in a device such as wear, crevices, or the effect of any galvanically induced potential on stress corrosion and corrosion fatigue. Surface changes such as scratches (possibly occurring during implantation) or welding effects (during production) are also not addressed. These mechanisms are beyond the scope of this test method.

Values ​​stated in SI units should be accepted as standard. No other units of measurement are included in this standard.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.

EUROLAB assists manufacturers with ASTM F3044 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.