ISO-10993-16 › Historical Revision Information
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

ISO-10993-16 - 3RD EDITION - CURRENT
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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.

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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-16:2017

Revision Level

3RD EDITION

Status

Current

Publication Date

May 1, 2017

Committee Number

ISO/TC 194