Biocompatibility International Pharmacopeia

ISO Pyrogen Study – Material Mediated (TU010)

Test Options/Variations

TU010-807
TU010-808Re-Test 5 Subject Model
TU010-827Naive - 3 Subject Model
TU010-828Naive Retest - 5 Subject Model

Pyrogen testing is performed to detect pyrogenic or fever responses following exposure to a medical device, bio-material, or their extracts.  The pyrogenic response may be due to endotoxin contamination or a “material-mediated” response associated with non-endotoxin materials that can cause a fever response

STANDARDS

ISO 10993-11

Related Tests
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