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NBN EN ISO 10993-16:2018

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Summary

ISO 10993-16:2017 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.

Technical characteristics

Publisher Bureau de Normalisation Belge (NBN)
Publication Date 01/30/2018
Cancellation Date 06/30/2018
Page Count 33
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