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Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 30-03-2020
Publisher: British Standards Institution
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. AnnexA describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
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