NA 027
DIN Standards Committee Optics and Precision Mechanics
Project
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Abstract
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.
Begin
2023-11-01
WI
00206103
Planned document number
prEN ISO 10993-16 rev
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
