DPS
Drejtoria e Përgjithshme e Standardizimit

0 Produkte

Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri

Main menu

ISO/CD 10993-16

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

General information

Current stage: 30.60 Effective date: 14 maj 2025

Originator: ISO

Owner: ISO/TC 194

Type: 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/CD 10993-16
30.60 Close of voting/ comment period
14 maj 2025