DIN EN ISO 10993-10:2013
This test is used for medical devices to assess irritation potential. 3D reconstructed human 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, viability is calculated using the MTT test (colorimetric assay). If remaining viability is > 50%, the medical device has no irritation potential.
|Mean tissue viability
(expressed as % of negative control)
|> 50%||non-irritant (NI)|
|≤ 50%||irritant (I)|