DIN EN ISO 10993-16:2018 Edition

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

Published By	Publication Date	Number of Pages
DIN	2018-02	24

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Categories: 11.100.20 - Biological evaluation of medical devices, DIN

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Description

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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2018-02
Pages Count	24
Language	Germany
Descriptors	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
File Size	1.4 MB
ICS Codes	11.100.20 - Biological evaluation of medical devices

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DIN EN ISO 10993-16:2018 Edition

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