The biological reactivity cytotoxicity test is performed according to the requirements described in the USP <87>. The test is designed to determine the biological reactivity of mammalian cell cultures following contact with the elastomeric plastics and other polymeric materials with direct or indirect patient contact or from specific extracts prepared from the material under test.
The test article, positive and negative controls are extracted in culture media for 24 hours at 37°C in a humidified incubator containing 5% of carbon dioxide. L-929 cells are treated with extract of the sample, reagent control, negative control or positive control. Duplicate plates are prepared for each treatment. The cells are incubated for 48 hours and observed microscopically for cytotoxic effects. Cultures are observed under microscopy and graded for reactivity using a 0 to 4 scale. Test article meets the requirement of the test when results are less than a grade of 2.
A report will be issued 15 business days after the receipt of the test substance.