Toxicity testing of medical device materials tested in human tissue cultures.

Rubber and plastic parts of medical devices were applied to human cell monolayers either directly or as aqueous extracts made at different time/temperature conditions. Thirteen rubber and twelve plastic samples were tested. The cultures were observed and photographed by use of a microscope with a camera before and after treatment with the test materials. The toxicity of the specimens was evaluated by comparison of the photographs. Alterations or disappearance of the cells or inhibited growth were interpreted as toxic effects of the materials. Twelve of the rubber and six of the plastic samples were evaluated as toxic in one or more of the systems.