DPS
Drejtoria e Përgjithshme e Standardizimit
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

ISO/WD 10993-16

Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables

General information

20.99     Sep 18, 2024

ISO

ISO/TC 194

International Standard

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
ISO 10993-16:2017

NOW

IN_DEVELOPMENT
ISO/WD 10993-16
20.99 WD approved for registration as CD
Sep 18, 2024