Specific safety evaluation programs follow International Organization for Standardization (ISO) 10993 standards and Food and Drug Administration (FDA) guidance. The matrix is based on ISO 10993-1 Evaluation and Testing within a risk management process 2009 edition, as well as the FDA Guidance released September 2016. While the matrix has been developed as a guideline for biocompatibility evaluation, it is essential that each device be evaluated based on its own unique characteristics.