ISO/AWI 10993-16

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

General information

Current stage: 20.00 Effective date: Oct 27, 2023

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

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

Revises
ISO 10993-16:2017

NOW

IN_DEVELOPMENT
ISO/AWI 10993-16
20.00 New project registered in TC/SC work programme
Oct 27, 2023

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