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ISO/DIS 10993-16

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

General information

40.00     Oct 8, 2025

ISO

ISO/TC 194

International Standard

11.100.20  

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

PROJECT
ISO/DIS 10993-16
40.00 DIS registered
Oct 8, 2025

National adoptions

nkSRPS EN ISO 10993-16:2024  
ISS

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

30.99   CD approved for registration as DIS

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