If An Orthopedic Implant Made Of Pure Titanium Or Titanium Alloy Material Is Treated With Colored Anodizing, And The Surface Of The Product Contains Residual Impurity Elements In Addition To The Matrix Element, How To Perform The Biological Evaluation?

For an orthopedic implant made of pure titanium or titanium alloy material is treated with colored anodizing, if there are additional residual impurity elements in addition to the matrix element, biological evaluation should be performed in accordance with the “Notice on Issuing the Guidelines for Biological Evaluation and Review of Medical Devices” (CFDA [2007] No. 345) and GB/T 16886 series standards to analyze the source of surface impurity elements and the reason for the introduction thereof, fully demonstrate the biological risk of the product, and meanwhile clarify the corresponding quality control measures of impurity elements in colored anodizing process.