The Biocompatibility Acute Systemic Toxicity test evaluates the potential adverse effects of a medical device on the body’s organs and tissues that are remote from the site of contact. Depending on the type of device being tested, the following applications may be observed for toxicity: topical, inhalation, intravenous, intra peritoneal, or oral administration of extracts, or implantation of the device in the animal. This test is performed on any device that would contact the interior of a patient’s body and complies with ISO 10993-11.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
- ISO 10993