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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: May 14, 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
May 14, 2025