Materials Technology
Associates, Inc.
Medical Device Testing
MEDICAL DEVICE CORROSION TESTING
 
  Performing ASTM F2129 corrosion test on 316L Stainless Steel



Water bath removed to display cell

MTA offers in-vitro corrosion testing for medical devices using standard test methods outlined in the FDA guidance documentation. Tests are typically performed in Hanks Solution at 37°C, and include ASTM F2129 and G71. Devices can be examined under the SEM to further characterize their corrosion characteristics.

 

The ASTM F2129 test is recommended by the FDA for evaluating the Corrosion Susceptibility of Small Implant Devices. In this test, the device is immersed in simulated bodily fluid such as Hanks solution, and cyclically polarized. The test provides data on the device’s corrosion resistance as well as its ability to reform a protective passive film.

 

Galvanic corrosion occurs when dissimilar materials are in contact with each other. This is of importance for implantable devices made of more than one material, such as a Stainless Steel Stent containing tantalum markers. Galvanic corrosion is assessed using the ASTM G71 test, which is recommended by the FDA.

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