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ISO 10993-16:2017

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
16 maj 2017

General information

90.92     27 tet 2023

ISO

ISO/TC 194

International Standard

11.100.20  

anglisht   frëngjisht  

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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WITHDRAWN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
27 tet 2023

REVISED BY

IN_DEVELOPMENT
ISO/DIS 10993-16

National adoptions

SSH EN ISO 10993-16:2017  
DPS

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 16: Projekti i studimit toksikokinetik për produktet e degradimit dhe substancat e filtrueshme (ISO 10993-16: 2017)

60.60 Standard published

DPS/KT 206 më tepër