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ISO 10993-23:2021

Current
Current

The latest, up-to-date edition.

Biological evaluation of medical devices Part 23: Tests for irritation
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

20-01-2021

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.

DocumentType
Standard
Pages
60
PublisherName
International Organization for Standardization
Status
Current

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£178.00
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