867622

CAN/CSA-ISO 10993-16-00 [ Withdrawn ]

Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables (Adopted ISO 10993-16:1997, first edition, 1997-09-01)

standard by Canada National Standard/Canadian Standards - ISO ,

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Scope

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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Number of Pages:
7
File Size:
1 file , 650 KB