CAN/CSA-ISO 10993-16-00:2000 Edition

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Biological Evaluation of Medical Devices – Part 16: Toxicokinetic Study Design for Degradation Products and Leachable

Published By	Publication Date	Number of Pages
CSA	2000	18

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Categories: 11.040.01 - Medical equipment in general, 11.100 - Laboratory medicine, CSA

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Description

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.

Additional information

Published Code	CSA
Published By	Canadian Standards Association
Publication Date	2000
Pages Count	18
Language	English
Descriptors	Medical Equipment, Medical Devices, Materials, Toxicity, Tests, Biological Tests, Determination, Toxicokinetics, General Conditions
File Size	1.1 MB
ICS Codes	11.040.01 - Medical equipment in general 11.100 - Laboratory medicine