ISO 10993-23:2020 Biological evaluation of medical devices — Part 23: Tests for irritation Approved!

The new ISO standard, ISO 10993-23:2020 Biological evaluation of medical devices — Part 23: Tests for irritation, has been approved and will be published shortly! As can be collected from the Final Draft International Standard (FDIS) of this update, this standard is designed to predict and classify the irritation potential of medical devices, materials, or their extracts according to ISO 10993-1 and ISO 10993-2. Therefore, this new standard will be essential to consider when moving forward with all biocompatibility evaluations as Annex A.1 of ISO 10993-1:2018 specifies that irritation effects assessment is necessary for all patient contacting devices. However, this "evaluation" can come from previous testing results to avoid re-testing medical devices. The critical difference is that this standard will focus more heavily on specific ways a medical device and its concentration/presence of particular materials and extracts could cause contact irritation. Lastly, this standard even sets forth new in vitro techniques, such as reconstructed human epidermis (RhE) models, to monitor skin irritation testing.

Visit ISO.org for an official timeline of the publication of the ISO 10993-23:2020 standard. See ISO/DIS 10993-23(en) for access to the foreword, introduction, scope, normative references, and terms and definitions of this new standard.



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