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summary
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables | Status: Current, Under review
description
1 Scope
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.
Details
Publisher
BS
File size
996.22 KB
Pages
28
Format
PDF
Publication date
2018-01-09
ISBN-13
978-0-539-13460-5
ISBN-13 plain
9780539134605
ISBN-10
0539134605