Biocompatibility Systemic Toxicity In-Vivo

FHSA Dermal Toxicity Study (TA003)

Test Options/Variations

TA003-80010 Subject - 14 Day
TA003-809FHSA Modified Dermal Toxicity Study - 5 Subject - 7 Day (FASTOX)

Toxicity tests evaluate the generalized biological effects to organs and tissues following exposure to a medical devices, bio-material, or their extracts.  The term systemic implies that the exposure occurs by one route and the toxic substance is carried to distant locations causing an adverse effect.  Toxicity is typically evaluated in studies of acute, sub-acute, sub-chronic, and chronic duration based on the device’s intended exposure

FHSA – Federal Hazardous Substances Act


Federal Hazardous Substances Act (FHSA)

ISO 10993-11

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