Medical Device Testing

CTL offers a wide variety of services related to medical devices and material analysis.  Our primary services are corrosion testing, including ASTM F2129 Cyclic Polarization.  We do offer other services related to material analysis, including SEM examination.  We stay active in the testing community to give our clients the advantage of understanding the developing recommendations set forth for testing by regulatory agencies.  CTL is a partner you can trust for your critical path item needs.

For any of the referenced services, or any corrosion or material related concerns, the CTL team is happy to work with you on a consulting basis to add our experience and background to your projects.

This test method is used to evaluate the susceptibility of a device to pitting and crevice corrosion. Typically medical devices are manufactured from materials that are resistant to corrosion. Evaluation of such materials for pitting corrosion would require very long exposure times in an immersion test.  Electrochemical testing allows the investigator to evaluate a metallic device for pitting corrosion in a very short time period. Hence, the FDA recommends this test as part of the corrosion evaluation for implantable devices.

Galvanic corrosion assessment is critical for anytime two different metals are contact with on another either on the same device or resulting from separate devices being in contact with one another after implantation. The electrochemical interaction between is two different metals present in an electrolyte can cause accelerated corrosion of the less resistant metal.  This testing helps assess the risk of this occurring.

CTL can perform a variety of long and short-term exposure tests.  For implants, this most commonly includes ion leaching and open circuit monitoring tests.  Short term tests include the boil test typically used on surgical instruments, such as ISO 11070:2014 Annex B, or ASTM F1089.

We currently do not provide fatigue-testing services geared toward mechanical property assessment.  We routine do perform examinations of samples post-fatigue testing to assess them for fretting-corrosion damage including optical microscopy, electron beam microscopy, and post fatigue electrochemical testing.   Should the need arise, our portable potentiostats allow us to provide electrochemical monitoring or testing coupled with your existing fretting corrosion setup.

Metallurgical services offered include preparation of metallographic cross-sections for examination of the microstructure and materials related consultation.

Our laboratory is fully equipped to perform failure investigations of implants when they do occur, including our new SEM, which allows high-magnification fractography of failed surface when needed.

Scanning electron microscopy allows for high-powered, high-magnification examination of the surface of the device.  It can be used to examine changes in surface morphology after laboratory exposure as well as  examination of explants or failed devices.