prEN ISO 10993-11 rev

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

General information

Current stage: 10.99 New project approved Apr 19, 2023

Originator: CEN

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

Type: European Norm

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

PREVIOUSLY

PUBLISHED
EN ISO 10993-11:2018

NOW

IN_DEVELOPMENT
prEN ISO 10993-11 rev
10.99 New project approved
Apr 19, 2023