CAN/CSA-ISO 10993-16-00 PDF

Name:
CAN/CSA-ISO 10993-16-00 PDF

Published Date:

Status:
[ Withdrawn ]

Description:

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.