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07674 An Assessment of ASTM F 2129 Electrochemical Testing of Small Medical Implants – Lessons Learned

Picture for 07674 An Assessment of ASTM F 2129 Electrochemical Testing of Small Medical Implants – Lessons Learn
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Product Number: 51300-07674-SG
ISBN: 07674 2007 CP
Author: Shari Rosenbloom and Richard A. Corbett
Publication Date: 2007
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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.
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.
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