Cytotoxicity Agar Diffusion
1. Biological Effect: Cytotoxicity Tests
2. Turnaround time: 4 weeks
3. Sample Requirements:
24 cm² (test item < 0.5 mm thick);
12 cm² (test item ≥ 0.5 mm thick);
at least 3 test items;
The purpose of the study is to determine the potential biological reactivity of a mammalian cell culture (cell line L929) in response to the medical device itselfs. The cells are allowed to grow to sub-confluency in tissue culture plates and exposed to the test item in 3 replicates. The plates are incubated for at least 24 hours at 37 °C. The biological reactivity of the cells following the exposure to the extracts is visually observed with a microscope, and graded on a scale of 0 (no reactivity) to 4 (severe reactivity). The medical device is considered non-cytotoxic if none of the cultures exposed to the test article extract shows greater than Grade 2 (mild reactivity).