Biomedical & Pharmaceutical

Implantable medical devices are generally made of proven corrosion resistant alloys. Nonetheless, the devices in their finished form may become susceptible to corrosion because of their processing history, configuration, and/or application. The devices or components might experience one or more forms of corrosion such as general corrosion, crevice corrosion, pitting, and stress-corrosion cracking. The resulting corrosion damage could not only impair the device, but also produce harmful biological consequences. For this reason, prior to use in the human body, small implantable medical devices must undergo rigorous testing to ensure that they will function properly in their intended environment.

DNV has investigated corrosion performance of many medical devices, including vascular stents, filters, mechanical heart valves, IUDs, and staples. We perform custom-designed corrosion tests specific to the device, as well as established ASTM Standard Tests (e.g., F 2129 - 06). Following the method, devices are tested in their final form and finish in an environment simulating body conditions (pH, temperature, and solution). All testing is conducted by experienced professionals adhering to quality assurance guidelines. The results of the testing can be used by clients to support the performance of a device to the United States Food and Drug Administration (USFDA).