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EN ISO 10993-23:2021/A1:2025

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025)

Publication date:   Oct 15, 2025

General information

60.60   Standard published   Aug 27, 2025

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 10993-23:2021

NOW

PUBLISHED
EN ISO 10993-23:2021/A1:2025
60.60 Standard published
Aug 27, 2025