The Material Mediated Pyrogen test is used to determine whether a saline extract of a medical device causes a pyrogenic response (fever) in rabbits. Nelson Laboratories performs this test in compliance with ISO 10993-11.
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Systemic Toxicity: Material Mediated Pyrogen, each
SCX320 - Systemic Toxicity: Material Mediated Pyrogen, each
SCX320: 900 cm2 or 30 grams. CSS Approval is needed to meet TAT.
In the Material Mediated Pyrogen test, a medical device is extracted in a 0.9% saline solution and injected into the marginal ear vein of each of three animals. Rectal temperatures will be recorded for each animal prior to injection and between 1 and 3 hours post-injection (at minimum 30 minute intervals). The test article will be considered negative if none of the animals has an individual temperature difference greater than or equal to 0.5°C when the baseline temperature is subtracted from the maximum temperature recorded between 1 and 3 hours post-injection. If any rabbit has an individual temperature rise greater than or equal to 0.5°C, then the sample is considered a potential pyrogen.