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EN ISO 10993-23:2021

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

Published date

31-03-2021

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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 10993‑1 and ISO 10993‑2.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.

Committee
CEN/TC 206
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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