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International Organization for Standardization (2016) ISO 10993-6: Biological Evaluation of Medical Devices—Part 6: Tests for Local Effects after Implantation.

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• TITLE: Degradation Rate Assessment of Biodegradable Magnesium Alloys

  AUTHORS: Bianmei Cao, Limei Cao, David F. Kallmes

  KEYWORDS: Magnesium Alloys, Biomedical Application, Biodegradation, Degradation Rate, Biocompatibility

  JOURNAL NAME: Materials Sciences and Applications, Vol.15 No.8, August 8, 2024

  ABSTRACT: Biodegradable magnesium alloys have been widely used in medical implants. But safety concerns were put forward for the high degradation rate of biodegradable magnesium alloy. The optimal biodegradable magnesium alloys that give rise to the desired degradation rate hasn’t yet to be defined. Assessing the degradation rate of biodegradable magnesium alloys involves in vitro testing, in vivo testing, numerical modeling, understanding the factors influencing their degradation in physiological environments, biocompatibility testing, and clinical studies. It is important to standardize analytical tools aimed at assessing the degradation rate of biodegradable magnesium alloys. It is advisable to identify the threshold for safe degradation rate of biodegradable magnesium alloys in biomedical applications.