BS EN ISO 10993-16:2017:2018 Edition

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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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Categories: 11.100.20 - Biological evaluation of medical devices, BSI

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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.

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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

Additional information

Status	Revision Underway
Title	Biological evaluation of medical devices – Toxicokinetic study design for degradation products and leachables
Corrects	BS EN ISO 10993-16:2017
Replaces	BS EN ISO 10993-16:2010
Publisher	BSI
Committee	CH/194
Pages	28
Publication Date	2020-03-30
ISBN	978 0 539 13460 5
Standard Number	BS EN ISO 10993-16:2017
Identical National Standard Of	EN ISO 10993-16:2017, ISO 10993-16:2017
Descriptors	Decomposition reactions, Leaching, Toxicity, Toxicology, Metabolism, Absorption, Design, Biological analysis and testing, Medical equipment, Degradation
ICS Codes	11.100.20 - Biological evaluation of medical devices

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BS EN ISO 10993-16:2017:2018 Edition

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