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.
pitting potential; breakdown potential
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.
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: F04.15
Staff Manager: Kathleen Chalfin
Date Initiated: 01-10-2022
Technical Contact: Brian Choules
Ballot: F04.15 (22-03)
Status: In Balloting