ISO 10993-23:2021/Amd 1

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ISO 10993-23:2021/Amd 1 is an amendment to the international standard for biological evaluation of medical devices, focusing on tests for irritation. It specifies procedures for assessing the potential of medical devices and their components to cause irritation, including pre-test considerations, in vitro and in vivo test procedures, and result interpretation. The amendment adds additional in vitro reconstructed human epidermis models to the standard.