Systemic toxicity
Systemic Toxicity (acute) evaluates the potential adverse effects of medical devices on the body's organs and tissues that are remote form the site of contact. Depending on the type of device being tested topical, inhalation, intravenous, intra peritoneal, or oral administration of extracts or implantation of the device in the animal is observed for toxicity. There are four categories: acute (24 hours), subacute (14 to 28 days) subchronic (90 days or 10% of an animals life span), and chronic (anything longer).This is outlined in ISO 10993-11.
Optional Tests for Systemic toxicity
Material mediated pyrogen ISO 10993
Systemic injection ISO 10993
