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SRPS 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)

Oct 31, 2025

General information

60.60     Oct 31, 2025

ISS

Z076

European Norm

11.100.20  

English  

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Scope

Измене су у: уводу, тачки 4, тачки 6.1, тачки 6.2.2, тачки 6.3.1, тачки 6.4.2, тачки 6.6.3, тачки 6.7.1, тачки 6.7.2, тачки 6.10, Прилогу C, Библиографији.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Directive 2017/745

Life cycle

NOW

PUBLISHED
SRPS EN ISO 10993-23:2021/A1:2025
60.60 Standard published
Oct 31, 2025

Related project

Adopted from EN ISO 10993-23:2021/A1:2025 IDENTICAL

Adopted from ISO 10993-23:2021/Amd 1:2025 IDENTICAL