ISO Pyrogen Study – Material Mediated.

Categories:

Standards:

ISO 10993-11

Related Services:

Test Description

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

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