BSI 19/30372368 DC:2019 Edition

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BS EN ISO 10993-23. Biological evaluation of medical devices – Part 23. Tests for irritation

Published By	Publication Date	Number of Pages
BSI	2019	74

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Categories: 11.100.20 - Biological evaluation of medical devices, BSI

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Description

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 10993-12.

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.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex D several special in vivo irritation tests are described for application of medical devices in areas other than skin. In addition, Annex E provides information for conducting human skin irritation testing.

Additional information

Status	Definitive
Pages	74
Publication Date	2019-05-13
Standard Number	19/30372368 DC
Title	BS EN ISO 10993-23. Biological evaluation of medical devices – Part 23. Tests for irritation
Identical National Standard Of	EN ISO 10993-23:2019
Descriptors	Biological tests, Evaluation, Medical equipment, Biological analysis and testing, Human body
Publisher	BSI
Committee	CH/194
ICS Codes	11.100.20 - Biological evaluation of medical devices

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BSI 19/30372368 DC:2019 Edition

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