Cytotoxicity endpoint is marked for all medical devices that contact the patient/user, regardless of type or duration of contact. A cytotoxicity test is an in vitro cell culture assay where the medical-device extract is placed in contact with mammalian fibroblast monolayer and their viability is measured either qualitatively or quantitatively. Cytotoxicity testing is widely used in the medical industry for screening purposes when there are changes occurring in either materials or processing or when evaluating the impact of device aging.
This whitepaper was adapted from the full published article in the Biomedical Instrumentation & Technology journal published by AAMI.
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