EN ISO 10993-5:2009/A11:2025

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity EN ISO 10993-5:2009/A11:2025

General information

Current stage: 60.60 Standard published Mar 5, 2025

Originator: CEN

Owner: CEN/TC 206 Biological and clinical evaluation of medical devices

Type: European Norm

ICS: 11.100.20 Biological evaluation of medical devices

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 10993-5:2009

NOW

PUBLISHED
EN ISO 10993-5:2009/A11:2025
60.60 Standard published
Mar 5, 2025