60.60 Standard published Dec 6, 2017
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 10993-16:2010
PUBLISHED
EN ISO 10993-16:2017
60.60
Standard published
Dec 6, 2017
IN_DEVELOPMENT
prEN ISO 10993-16 rev