Work Item
ASTM WK80475
New Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices: Simulated In-vivo conditions
1. Scope
This test method assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization under simulated in- vivo conditions. This is a modification of ASTM F2129 that allows for longer immersion times prior to cyclic polarization and aeration or other modifications of the electrolyte to simulate in vivo conditions. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents (Specification F1828), filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.Keywords
pitting potential; breakdown potentialRationale
ASTM F2129 does not allow for using oxygenated electrolyte or for longer open circuit immersion times. These conditions have been shown to affect the results of the test and are more representative of conditions related to vascular devices. Users would be those developing small implants.
Work Item Status
Date Initiated: 01-10-2022
Technical Contact: Brian Choules
Item: 001
Ballot: F04.15 (22-03)
Status: Will Reballot Item