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prEN ISO 10993-16 rev

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables prEN ISO 10993-16 rev

General information

10.99 New project approved   Nov 1, 2023

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

Scope

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the 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 10993-16:2017

NOW

IN_DEVELOPMENT
prEN ISO 10993-16 rev
10.99 New project approved
Nov 1, 2023