DIN EN ISO 10993-10:2013
This test is used for medical devices to assess irritation potential. 3D human reconstructed models are exposed to an extract of a medical device for at least 15 minutes. After exposure models are rinsed and post-incubated for 42 hours. After incubation vitality is calculated by MTT-test (colorimetric assay). If remaining vitality is > 50 %, the medical device had no irritation potential.
|Mean tissue viability
(expressed as % of negative control)
|> 50 %||non-irritant (NI)|
|≤ 50 %||irritant (I)|