This cytotoxicity test is performed according to the requirements described in Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ANSI/AAMI/ISO 10993-5). The test is designed to determine the biological response of mammalian cells exposed in vitro to extracts of the devices.
The test article, positive and negative controls are extracted according to the method ISO 10993-12. The original extract is serially diluted and 5 concentrations are used for testing. L-929 cells are treated with extracts of the sample, reagent control, negative control or positive control. Triplicate plates are prepared for each treatment. The cells are incubated for 24 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 4-6 weeks after the receipt of the test substance.