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
The Material Mediated Pyrogen Test (MMP) looks for the presence of pyrogen in a sample. A pyrogen is any material or chemical that causes a fever. The test article extraction will be injected into the marginal ear vein of each of three animals. Temperatures will be recorded for each animal prior to injection and between 1 and 3 hours post-injection. The test looks for a temperature rise post injection.
Systemic injection ISO 10993
The Acute Systemic Injection test looks for potential toxic effects as a result of a single-dose injection in mice. Mice will be injected intraperitoneally or intravenously and observed for signs of toxicity immediately after injection up to 72 hours post-injection.
