Abstract
Repeated or continuous exposure/interaction of medical devices with the human body results in release and accumulation of toxic chemicals. Long-term tests (subacute, subchronic, chronic) are used to identify the potential effects such as its toxicity, target organs, reversibility, or other effects from repeated or continuous exposure of medical devices. Due to variable duration for repeated exposure, the repeated-exposure systemic toxicity evaluation requires scientifically approved pilot design, unbiased and quantitative pathological, and clinical chemistry methods to ensure stability.
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