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

Current stage: 10.99 New project approved Nov 1, 2023

Originator: CEN

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

Type: 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.

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