ISO 10993-23:2021
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The latest, up-to-date edition.
Biological evaluation of medical devices Part 23: Tests for irritation
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English, French
01-20-2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 109931 and ISO 109932.
This document includes:
pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vitro and in vivo irritation test procedures;
key factors for the interpretation of the results.
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