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ISO 10993-23:2021

Current Revision

Biological evaluation of medical devices - Part 23: Tests for irritation

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 10993
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 194
Publish Date Document Id Type View
Not Available ISO 10993-23:2021 Revision