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 10993-16:2017

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

May 16, 2017

General information

90.92     Oct 27, 2023

ISO

ISO/TC 194

International Standard

11.100.20  

English   French  

Buying

Published

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-16:2010

NOW

PUBLISHED
ISO 10993-16:2017
90.92 Standard to be revised
Oct 27, 2023

REVISED BY

PROJECT
ISO/CD 10993-16

National adoptions

SRPS EN ISO 10993-16:2018  
ISS

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60   Standard published

Z076 more