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BS EN ISO 10993-16 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Source:
ISO
Committee:
CH/194 - Biological evaluation of medical devices
Categories:
Medical devices. Biological evaluation
Comment period start date:
Comment period end date:
Number of comments:
0

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Scope

This document describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices and provides principles on designing and performing toxicokinetic evaluation relevant to medical devices.

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