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. This represents a revolution within the biocompatibility of medical devices process underlining the significant progress achieved in the evaluation of skin irritation potential in the medical device sector.
The introduction of the new ISO 10993-23 standard 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 opening the possibility to introduce new testing approaches based on human reconstructed tissues. Consequently a change in mindset for which industry needs to prepare – 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 experts will illustrate through specific examples, the range of success of in vitro testing methods as an alternative to in vivo testing.