Test Method for Human Cell-Culture Elution to Evaluate Medical Materials and Devices for Cytotoxicity

    Published: Jan 1983

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    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.


    cell culture, extraction, WI-38, cytotoxicity

    Author Information:

    Ettorre, LM
    Research associate and microbiologist, Extracorporeal, Inc., PA

    Phillips, K
    Research associate and microbiologist, Extracorporeal, Inc., PA

    Committee/Subcommittee: F04.15

    DOI: 10.1520/STP30151S

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