SEDL / STP / STP810-EB / STP30154S

Evaluation of Materials Used for the Fabrication of Medical Devices: Cytotoxicity Testing

Horres, CR
Duke University, Durham, N. C.

Mears, HG
Research technologist and director, Becton Dickinson Research Center, Research Triangle Park, N. C.

Wilsnack, RE
Research technologist and director, Becton Dickinson Research Center, Research Triangle Park, N. C.

Moore, GE
Lab director, Biosearch, Philadelphia, Pa.

Pages: 16    Published: Jan 1983

Download this paper for $25 PDF (492K)          View License Agreement
Abstract

Becton Dickinson has been involved in cell-culture testing of medical devices for the past ten years using WI-38 cells as a human origin in vitro target system. Two modes of tissue-culture testing are used at Becton Dickinson: cytotoxicity score and inhibition of cell growth. To determine score, cell monolayers are scored microscopically as to the degree of morphologically discernable cytotoxicity after incubation for 24 and 72 h with culture media used to eluate test materials. Inhibition of cell growth is determined by culturing cells for 24 h in test material eluate then trypsinizing and reseeding using the elution fluids as growth menstruum. The plates are incubated, and when negative controls indicate a 100% monolayer, the cell monolayers are fixed and stained. The cells are scored microscopically as to the percent of growth inhibition in relation to the negative control. This system has provided a sensitive, reproducible, and short duration evaluation mechanism for biomaterials.