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Normas DIN – AENOR
DIN EN ISO 10993-16:2018-02

DIN EN ISO 10993-16:2018-02

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

Évaluation biologique des dispositifs médicaux - Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables (ISO 10993-16:2017); Version allemande EN ISO 10993-16:2017

Biologische Beurteilung von Medizinprodukten - Teil 16: Entwurf und Auslegung toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und herauslösbaren Substanzen (ISO 10993-16:2017); Deutsche Fassung EN ISO 10993-16:2017

Fecha:
2018-02 /Active
Equivalencias internacionales:

EN ISO 10993-16 (2017-12)

ISO 10993-16 (2017-05)

TS EN ISO 10993-16 (2018-03-19)

Relación con otras normas DIN:
Resumen:
This document 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.
Keywords:
Basis, Bioassay, Biological, Biological hazards, Biological tests, Definitions, Degradability, Degradation, Design, Determination, Distribution, Evaluations, Experimental design, Experimental set-up, Extracts, Guide books, Half-life, Information, Investigations, Medical devices, Medical equipment, Medical products, Metabolism, Methods, Organisms, Precipitation, Products, Test performance, Testing, Toxicity, Toxicokinetic, Toxicological, Toxicological testing, Toxicology
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