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)

Publisher:
Canada National Standard/Canadian Standards - ISO

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

1

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.

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

CAN/CSA-ISO 10993-16-00 PDF

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)

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