ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation.
The long-awaited ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation has been finally published!
Irritation tests of medical devices were taken out from ISO 10993-10, and now are fully described in dedicated ISO 10993-23 – many changes have been introduced…
This documents describes a stepwise approach for irritation testing of medical device. Furthermore, a new in vitro alternative test using Reconstituted human Epidermis was described.
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