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The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results

Published In: ScienceDirect

Irritation testing is identified as one of the most performed biocompatibility tests for medical devices. This is due to the requirement for evaluation which is laid out in ISO 10993-1:2018: Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process.

The testing for this biological response is outlined in ISO 10993-10: Tests for irritation and skin sensitization, which currently only includes in vivo testing options as widely accepted methods to predict an irritation response. The international community involved with these standards has been working for the last several years to demonstrate that an adapted OECD method used for chemicals (OECD 439) can accurately predict irritation responses from medical device extracts. This article is the most recent in a line of publications from this community which specifically addresses the fact that the in vitro irritation model using reconstructed human epidermis (RhE) tissues can produce results equivalent to the most popular in vivo irritation test, the intracutaneous injection test.


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