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White PaperTest & Measurement

Cytotoxicity Failure - What Now?


Medical devices come in all shapes and sizes and are designed to treat patients and improve their quality of life. As the first rule for medical industry, it needs to be demonstrated that the products will do no harm when used on or exposed to the patient. The biological evaluation is a key part of ensuring patient safety and is required for all medical devices that come into contact with the patient/user.

Documents such as the ISO 10993-1 provide guidance on what to consider when evaluating your medical device, such as intended contact type and duration, available information on materials and processing, published literature, previous regulatory submissions, and existing gaps in knowledge that should be followed up with additional supplementary testing.

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 white paper highlights steps to follow when you discover that your cytotoxicity test result indicates a failure.

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