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Cytotoxicity Failure – What Now?

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.

Read about the author below.

Helin Räägel

Helin Räägel

Senior Biocompatibility Expert

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...

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