Element provides cyclic potentiodynamic polarization testing per ASTM F2129 to determine the corrosion susceptibility of small, implantable devices.
The human body offers a corrosive environment for any metallic implantable device. Corrosion can have a negative effect on a device's performance, it may result in the release of byproducts which have a harmful biological consequence, or it may cause a device to fail altogether. A device’s susceptibility to corrosion is directly affected by the materials involved, the fabrication process, and several other factors.
Element offers testing services which accurately access the corrosion susceptibility of small, metallic, implantable medical devices, or components thereof, by using cyclic potentiodynamic polarization in accordance with ASTM F2129. The device is placed in a chamber filled with inert, simulated physiological fluid until a stable voltage potential is found. A potentiodynamic scan then begins in the noble direction, and is then either reversed at the vertex potential or once the specimen has shown signs of pitting, crevice, or other corrosive breakdown. Data is then provided with the current or current density on the x axis versus the potential on the y axis.
ASTM F2129 is designed to reach conditions that are sufficiently severe enough to cause corrosion, and these conditions may not be encountered in vivo. The data is useful for understanding the breakdown potential of a small medical device, or for comparing devices with differing materials, designs, or fabrication processes.
Sample Polarization Scans
Example 1: Study conducted on five devices that resulted in no signs of corrosion
Example 2: Study conducted on one device that resulted in breakdown and re-passivation
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Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.
Kent is the co-founder of Medical Device Testing Services, acquired by Element in 2017. Kent’s expertise in medical device testing has led to the development of new test instruments, standards and protocols.