ISO issues standard revision ISO10993-23:2021: Biological evaluation of medical devices — Part 23: Tests for irritation
ISO issued a revision of ISO 10993-1: “ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation”. The revised standard “specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation” by describing tests to assess the irritancy of medical devices materials/extracts either by in vitro or in vivo tests.
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Among others, ISO 10993-23:2021 introduces an important change in the procedures for the biological evaluation of medical devices as the use of animal models, in place for 70 years for the evaluation of irritation, is now replaced by an in-vitro test on reconstructed epidermis.
For more details, please see the official document from ISO.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
