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university of tampere: faculty of medicine and life sciences: ecopa ssct workshop 2017: program:
Faculty of Medicine and Life SciencesUniversity of TampereFaculty of Medicine and Life Sciences
ecopa SSCT Workshop 2017

Technical Workshop

Assessment of Skin Irritation of Medical Devices Extracts In Vitro   



Theoretical part: Lecture 20 min + 10 min discussion

Evaluation of Skin Irritation of Medical Device Extracts Using Reconstructed Human Epidermis EpiDerm.
Authors: Dr. Helena Kandarova and Dr. Silvia Letasiova, MatTek, Slovak Republic


Practical part: 1 hour

Hands-on-training: EpiDerm–SIT-MD Protocol for Skin Irritation Testing of Medical Devices
Trainers: Dr. Silvia Letasiova and Dr. Helena Kandarova, MatTek, Slovak Republic



Assessment of dermal irritation is an essential component of the safety evaluation of medical devices. Reconstructed human epidermis (RhE) models have replaced rabbit skin irritation testing in the area of classidication and labeling of chemicals (REACH/OECD TG 439) and are also for more than 20 years used for the safety assessment of final cosmetic and household formulations (see e.g. Faller et al, 2002).

However, safety assessment of medical devices (MD) with regard to skin irritation is based mainly on the extracts (ISO 10993) and these extracts are dilute solutions with low irritation potential. Therefore the validated RhE-based methods needed to be modified to reflect needs of ISO 10993 in detection of very low irritation potential of MD extracts. 

A protocol employing RhE EpiDerm was optimized in 2013 using known irritants and spiked polymers (Casas et al., TIV, 2013) and in 2014, the transferability of the protocol was assessed (Kandarova et al. 2015). An international Round Robin validation study was conducted  in 2016 and the results were presented at the US SOT this year (De Jong et al., 2017).

This technical workshop will provide technical information about skin irritation testing of medical device extracts using EpiDerm tissue model and practical hands-on training of this method.


  • Faller et al., 2002. Predictive ability of reconstructed human epidermis equivalents for the assessment of skin irritation of cosmetics. Toxicology in Vitro 16 (2002) 557–572.
  • Casas et al., 2013. In vitro human skin irritation test for evaluation of medical device extracts. Toxicology in Vitro 27 (2013) 2175–2183
  • Kandarova et al., 2015. Development, Optimization, and Standardization of an In Vitro Skin Irritation Test for Medical Devices Using the Reconstructed Human Tissue Model EpiDerm. The Toxicologist, Volume 144, Issue 1
  • De Jong et al., 2017. Round Robin Study to Evaluate the Reconstructed Human Epidermis (RhE) Model as In Vitro Skin Irritation Test for Detection of Irritant Activity in Medical Device Extracts. The Toxicologist, Volume 156, Issue 1
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Last update: 31.5.2017 15.45 Muokkaa

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