The security risk of magnesium alloys used as biodegradable implant material was evaluated in this study. Dose-response assessment was conducted by using toxicological data from authoritative public health agencies (World Health Organization) and assuming 1~3 years of uniform corrosion. Through modification calculation, the tolerable corrosion rate of biodegradable magnesium alloys in vivo was proposed, which theoretically ensured the bio-safety of the degradation products. The tolerable limits corresponding to various component elements in magnesium alloys were considered separately, although there are deficits in the toxicological data of some component elements. The influence of corrosion on the strength of magnesium alloys was evaluated, which would contribute to the rationally utilization of magnesium alloys as degradable implant materials. This study illustrates that not only toxicological calculations but also mechanical performance should be taken into consideration when developing novel degradable metallic implant.
Keywords: Risk assessment; biocompatibility; biodegradation; magnesium alloys.