ISO 10993-16:2017

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

Publication date: May 16, 2017

General information

Current stage: 90.93 Effective date: Sep 5, 2022

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Languages: English French

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Status: Published

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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 10993-16:2010

NOW

PUBLISHED
ISO 10993-16:2017
90.93 Standard confirmed
Sep 5, 2022

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