Table 13.

TÜV SÜD sample of a risk assessment and their standards, summarized from [67].

Test	Standards	What Does It Evaluate?
Cytotoxicity	ISO 10993-5 [67]	Test for toxicity of medical device or material on cell culture.
Genotoxicity	ISO 10993-3 and FDA [67]	Test for toxins that affect the genetic material of cells.
Hemocompatibility	ISO 10993-4 and ASTM [67]	Test for effects of blood-contacting medical devices on blood.
Irritation and Sensitization	ISO 10993-10 [67]	Test for skin irritability and adverse cutaneous reactions.
Systemic Effects	ISO 10993-11 and ASTM [67]	Test for effects of medical devices on the body, for example, the possibility of fever and toxicity.
Implantation	ISO 10993-6 [67]	Test for effects of medical devices on surrounding tissue at various levels of visibility.