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Systemic Toxicity Test

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>

Testing Locations

  • Salt Lake City, UT, USA

To learn more about our locations and their certifications, click here.

Contact Us

If you have additional questions about Acute Systemic Toxicity tests services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.