0 Items
My account
Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

ISO/DIS 10993-16

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

General information

40.60     Mar 3, 2026

ISO

ISO/TC 194

International Standard

11.100.20  

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

PROJECT
ISO/DIS 10993-16
40.60 Close of voting
Mar 3, 2026

National adoptions

naSRPS EN ISO 10993-16:2024  
ISS

Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025)

40.60   Close of voting

Z076 more