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CAN/CSA-ISO 10993-16-00
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)
SKU: 2413209
Published by CSA Group
Publication Year 2000
7 pages
Withdrawn
Product Details
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.
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.