An Assessment of Astm F 2129 Electrochemical Testing of Small Medical Implants - Lessons Learned
نویسندگان
چکیده
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.
منابع مشابه
Laboratory Corrosion Testing of Medical Implants
Performance evaluation of implantable devices is not new to medical device manufacturers, specifically implant manufacturers. A focus on corrosion resistance of implant devices has prompted members of the medical device industry, along with the United States Food and Drug Administration [USFDA] to set forth a guide for performance testing. Although actual corrosion resistance of a material can ...
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