ISO 10993-16:2017

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

Publication date: 16 maj 2017

General information

Current stage: 90.92 Effective date: 27 tet 2023

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Gjuha: anglisht frëngjisht

Buying

Statusi: Publikuar

PDF - 10 855 Lekë

Paper - 10 855 Lekë

CD - 10 855 Lekë

Language

Language in which you want to receive the document.

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
90.92 Standard to be revised
27 tet 2023

REVISED BY

IN_DEVELOPMENT
ISO/AWI 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

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.