45.99 Dispatch of FV draft to CCMC Aug 31, 2026
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
This document describes the considerations to include the toxicokinetic evaluation of single chemical which can include its degradant or metabolite known to be released from a medical device. This document provides the principles for designing and performing a toxicokinetic evaluation for medical devices.
Legislation related to this standard
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
PUBLISHED
EN ISO 10993-16:2017
IN_DEVELOPMENT
prEN ISO 10993-16
45.99
Dispatch of FV draft to CCMC
Aug 31, 2026