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Test Method for Human Cell-Culture Elution to Evaluate Medical Materials and Devices for Cytotoxicity Pages: 7 Published: Jan 1983
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View License Agreement Tissue-culture testing used for screening selected new-components as well as for lot-to-lot testing of designated incoming materials before approval for use is performed routinely by the employees of the Microbiology Department at Extracorporeal, Inc. The “extraction method,” which uses the WI-38 cell line, is used most often. MRC-5 cells, a similar cell line, are also maintained as an alternate. Materials are extracted on a surface area or weight ratio basis at 37°C for 24 h. The growth media is aspirated from the plates, replaced with extracting media, and incubated at 37°C for 24 h. Plates are stained, dried, and examined under a light microscope. Cytotoxicity is scored on a scale of 0 (negative response) to 4 (more than 75% of cells morphologically changed). Results of +2 to +4 are considered cytotoxic. Retesting is done to verify cytotoxic results. | ||
