ISO 10993-23:2021

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

Publication date: Jan 20, 2021

General information

Current stage: 90.20 Effective date: Jan 15, 2026

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Languages: English French

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Status: Published

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 10993-23:2021
90.20 Standard under periodical review
Jan 15, 2026

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 10993-23:2021/Amd 1:2025

REVISED BY

IN_DEVELOPMENT
ISO/PWI 10993-23

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