Specific safety evaluation programs follow International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance (May 1, 1995). The table is based on ISO 10993-1 Evaluation and Testing, 2009 edition. While the table has been developed as a guideline for biocompatibility testing, it is essential that each device be evaluated based on its own unique characteristics.

T2.005_Biocompatibility_Matrix