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EVS-EN ISO 10993-16:2010

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

General information
Withdrawn from 18.12.2017
Base Documents
ISO 10993-16:2010; EN ISO 10993-16:2010
Directives or regulations
None
Standard history
Status
Date
Type
Name
18.12.2017
Main
06.04.2010
Main
Main
EVS-EN ISO 10993-16:2009
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
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