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prEN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2026)

Publication date:   May 21, 2026

General information

40.60   Close of voting   Jul 8, 2026

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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Scope

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

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

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EN ISO 10993-11:2018

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prEN ISO 10993-11
40.60 Close of voting
Jul 8, 2026