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BS EN ISO 10993-16:2017:2018 Edition

BS EN ISO 10993-16:2017:2018 Edition

$142.49

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

Published By Publication Date Number of Pages
BSI 2018 28
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Principles for design of toxicokinetic studies
5 Guidance on test methods
5.1 General considerations
13 5.2 Guidance on specific types of test
5.2.1 General
5.2.2 Absorption
5.2.3 Distribution
14 5.2.4 Metabolism and excretion
15 Annex A (normative) Circumstances in which toxicokinetic studies shall be considered
17 Bibliography

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BS EN ISO 10993-16:2017
$142.49