The Acute Systemic Injection Test provides general information on health hazards likely to arise from an acute exposure from a medical device or chemical material. The animals are dosed, intravenously and/or intraperitoneally, with test article extracts or the liquid chemical, and then observed at 24 ± 2, 48 ± 2, and 72 ± 2 hours for various signs of toxicity.
The Material Mediated Pyrogen evaluates the ability of a chemical agent or other substance in/on a medical device to produce a pyrogenic response. The animals are dosed with the test article extract via intravenous injection and observed for 3 hours. This observation period is looking for a temperature change of less than +0.5°C in each animal.
These tests can be performed on any device that would contact the interior of a patient’s body. These tests comply with the ISO 10993-11 and ISO 10993-12 standards.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
Applicable Standards
- ISO 10993-11
- ISO 10993-12
- USP <151>
