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ISO 10993-16:2017

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

May 16, 2017

General information

90.92     Oct 27, 2023

ISO

ISO/TC 194

International Standard

11.100.20  

English   French  

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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

WITHDRAWN
ISO 10993-16:2010

NOW

PUBLISHED
ISO 10993-16:2017
90.92 Standard to be revised
Oct 27, 2023

REVISED BY

IN_DEVELOPMENT
ISO/WD 10993-16

National adoptions

SSH EN ISO 10993-16:2017  
DPS

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60 Standard published

DPS/KT 206 more