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ISO/CD 10993-16

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

General information

30.20     Mar 18, 2025

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/CD 10993-16
30.20 CD study/ballot initiated
Mar 18, 2025

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