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Material Mediated Pyrogen Test

Material Mediated Pyrogen Test

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.

Applicable Standards

  • ISO 10993-11

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
SCX320 Systemic Toxicity: Material Mediated Pyrogen, each 40 Add
SCX320 - Systemic Toxicity: Material Mediated Pyrogen, each
TAT: 40 days

Sample Specifications

SCX320: 900 cm2 or 30 grams. CSS Approval is needed to meet TAT.

Study Outline

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.
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