Irritation testing
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.
Prediction Model
| Mean tissue viability (expressed as % of negative control) |
Prediction |
| > 50% | non-irritant (NI) |
| ≤ 50% | irritant (I) |