Biocompatibility Systemic Toxicity In-Vivo

Chronic Systemic Toxicity Study in Subjects Following Implant (T0118)

Test Options/Variations

T0118-92626 Wk

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.  Systemic toxicity is typically evaluated in studies of acute, sub-acute, sub-chronic, and chronic duration based on the device’s intended exposure. Chronic  decribes the longer duration of the study.

STANDARDS

ISO 10993-11

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