Corrosion is the deterioration of materials (typically metal) caused by an electrochemical reaction with their environment. Corrosion testing is critical to understanding how a material reacts with its environment. Clients use Eurofins EAG corrosion testing services to solve, prevent, and mitigate corrosion problems including, premature failure, structural integrity, and contamination. In addition, corrosion testing helps ensure proper materials selection, a critical manufacturing step that prevents future problems.
Corrosion testing is particularly important in medical device systems since uncontrolled release of metallic ions can have damaging biological effects.
ASTM F2129 (Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices) is a corrosion susceptibility test for small implant devices, individual components of the devices, or other material samples made from metal. Potentiodynamic polarization in a cyclic manner (forward and reverse) is used to perform the test.
Medical devices which can be assessed by ASTM F2129 include but are not limited to:
The cyclic potentiodynamic polarization tests are conducted in accordance with the most current version of ASTM F2129. This standard specifies that a specimen be exposed to a specific solution (phosphate buffered saline electrolyte (PBS) or another medium depending on what the medical device is exposed to in the human body) in a test cell with a saturated calomel electrode (SCE) as the reference electrode and a counter electrode (graphite).
The FDA recognizes the complete standard and accepts ASTM F2129 corrosion testing to assess the robustness of the oxide layer of the final finished form of the medical device (in the condition of which it enters and exists in the body).
Eurofins EAG can accommodate any customization needed for ASTM F2129 corrosion testing for internal quality control and third party verifications.
In addition, SEM imaging can be added before and after corrosion testing to further characterize the corrosion.
Customization for any of the above corrosion testing is available upon request.
Contact us today for your Corrosion Testing needs. Please complete the form below to have an EAG expert contact you.
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