Systemic 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

MHLW – Ministry of Health, Labour and Welfare