Biocompatibility Sensitization In-Vivo

ISO Maximization Sensitization Study (TI261)

Test Options/Variations

TI261-300Extract
TI261-302Extract Rechallenge
TI261-304Positive Control Report
TI261-306Solution
TI261-307Solution Rechallenge

Sensitization tests are utilized to evaluate the potential of medical devices, bio-materials, or their extracts tissues to cause a sensitizing effect or allergic reaction following exposure. The method selected is based on the type of tissue contact

STANDARDS

ISO 10993-10

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