Irritation testing
DIN EN ISO 10993-23:2021
This test is designed to predict and classify the skin irritant potential of extracts from medical devices according to the requirements of ISO standards 10993-1:2009, 10993-5:2009, 10993-10:2010, and 10993-12:2012 using the RhE model EpiDerm™ (EPI-200) and parameters related to skin irritation. 3D reconstructed human skin models are exposed to an extract of the medical device for at least 18 hours. After exposure, supernatant can be collected for the analysis of cytokines (e.g. IL-1α, optionally). Subsequently, models are rinsed and viability is assessed using the MTT test (colorimetric assay). If remaining viability is > 50%, the medical devices have no irritation potential.
Prediction Model
| Mean tissue viability (expressed as % of negative control) |
Prediction |
| > 50% | non-irritant (NI) |
| ≤ 50% | irritant (I) |