Cytotoxicity test method for medical devices

Abstract

A cytotoxicity method for medical devices that has equivalent sensitivity, and greater efficiency compared to the colony formation assay (CFA) direct contact method is developed. The quantitative, direct contact cytotoxicity test method uses Mouse lymphoma TK or human lymphoblastoid TK6 suspension cells for medical device safety assessment. The advantages of using the suspension cell assay over adherent V79-4 cells is that this approach is quantitative, automated, not susceptible to potential mechanical damage imparted by the overlying test materials, and avoids issues related to non-adherence of cells to the test material which might impact the interpretation of test results.

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