An assessment of astm f2129 electrochemical testing of small medical implants - lessons learned

ABSTRACT: Much has been learned over a short period of time with respect to the corrosion assessment of small medical implant devices. Laboratory testing started with modifications of ASTM G 5 and G 61, which lead to the development of ASTM F 2129, and thence the fine-tuning of that specification to meet the intent of the FDA Guideline for non-clinical tests. The changes in electrochemical testing protocol with time are reviewed. Comparative data is presented addressing test environments, scan rates, statistical replication, alloy response, and acceptance criteria.