Medical Devices



In vitro skin irritation test for medical device





Biological evaluation of medical devices:
Standard Operating protocol (SOP) for in vitro skin irritation test with SkinEthicTM RHE model



The in vitro skin irritation test with SkinEthicTM RHE model is designed for the prediction of acute skin irritation of medical devices by measurement of cytotoxic effects of extract (prepared according to ISO10993-12), as reflected in the MTT assay, on the SkinEthic Reconstructed Human Epidermis (RHE) model.




  SkinEthicTM RHE - Reconstructed Human Epidermis




SkinEthicTM RHE model can be used for in vitro skin irritation assessment for biological evaluation of medical devices.



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SkinEthic™ RHE for in vitro evaluation of skin irritation of medical device extracts. Pellevoisin C, Videau C, Briotet D, Grégoire C, Tornier C, Alonso A, Rigaudeau AS, Bouez C, Seyler N.  Toxicol In Vitro. 2018 Aug;50:418-425. doi:10.1016/j.tiv.2018.01.008.


Round robin study to evaluate the reconstructed human epidermis (RHE) model as an in vitro skin irritation testfor detection of irritant activity in medical device extracts. De Jong WH, Hoffmann S, Lee M, Kandárová H, Pellevoisin C, Haishima Y, Rollins B, Zdawczyk A, Willoughby J, Bachelor M, Schatz T, Skoog S, Parker S, Sawyer A, Pescio P, Fant K, Kim KM, Kwon JS, Gehrke H, Hofman-Hüther H, Meloni M, Julius C, Briotet D, Letasiova S, Kato R, Miyajima A, De La Fonteyne LJJ, Videau C, Tornier C, Turley AP, Christiano N, Rollins TS, Coleman KP.  Toxicol In Vitro. 2018 Aug;50:439-449. doi: 10.1016/j.tiv.2018.01.001