ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation has been published last year. This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis (RhE) model.
ISO 10993- 23 introduces the shift from in vivo to in vitro for the assessment of irritation potential of medical devices. The standard officially recognizes in vitro as an approved method for understanding, predicting and classifying skin irritation risk in medical devices. Its robustness is also what makes the in vitro testing a valuable safeguard. This is leading the path towards the transition to alternative toxicology to assess the biocompatibility of devices.
in vitro science, is evolving at a fast speed introducing new testing approaches based on human reconstructed tissues. When combined with pyrogenicity and cytotoxicity testing, the skin irritation tests is an effective complement to biocompatibility testing manufacturers might perform in the early stages of development. This means that fabricants need to be receptive and responsive to the new methods.
This event offers a unique opportunity to achieve a better understanding of the evolution of the ISO 10993 standard and the application of validated in vitro test methods. This webinar will provide sound knowledge on the implementation of an in vitro testing strategy, not only in the scope of the recent ISO 10993-23, but also on how alternative methods can be considered an effective and robust approach to in vivo testing.
Taking into account medical device’s intended purpose, this presentation will present key strategic outcomes of in vitro testing to consider when developing your biocompatibility testing strategy. Thanks to the expertise achieved in developing in vitro testing methods, our Regulatory Senior Consultant and in vitro testing Laboratory Manager will illustrate through specific examples, the range of success of in vitro testing methods as an alternative to in vivo testing.