CAPABILITY | BIOMEDICAL ENGINEERING & SCIENCES

Medical Device Corrosion

Fatigue & Corrosion [BES]

Evaluate the corrosion performance of medical devices

Exponent performs fatigue and corrosion testing for medical device companies to assist with product development, quality assurance, regulatory submissions, and post-market surveillance.

Evaluate medical implant corrosion performance under a range of conditions.

In vitro corrosion testing of medical devices and implants such as stents, clips, valves, dental implants, and joint replacement components can be performed to understand their electrochemical behavior and the release of associated degradation products during their service life.  

In vitro tests assess corrosion and performance in vivo conditions.

Exponent performs in vitro corrosion tests on medical devices to assess their corrosion performance under simulated in vivo conditions. Exponent regularly performs several different corrosion test methods to evaluate the short- and long-term corrosion potential, metal ion release, and breakdown and repassivation potentials of a variety of implantable medical devices in a wide range of shapes and sizes.  Exponent also has extensive experience evaluating corrosion in retrieved medical devices.

Customized tests based on standardized techniques.

Our implant corrosion tests are performed using ASTM Standards F2129, F3044, F3306, F1875, and G71 and ISO Standard 16429 as guides, and we also design customized tests based on standardized techniques to evaluate unique device designs and geometries. We can evaluate electrochemical characteristics, including resistance to different types of corrosion, for various alloys used in medical devices.

Characterization of device materials and assessment of corrosion damage.

We have also helped several medical device manufacturers characterize fretting and corrosion damage in retrieved implants using physical measurements of total joint replacement components using ASTM F2979 and F3129 as guides.

State-of-the-art laboratories to characterize materials and chemical composition of devices.

Our labs have the capability to characterize implants and their materials to determine the amount, size distribution, and chemical composition of inclusions in their alloys and other features that can affect corrosion behavior using a variety of surface analytical techniques.  

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