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BSI BS EN ISO 10993-16: Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables

Publication Date: Mar 31, 2010
SDO: BSI: British Standards Institution
 DOD Adopted   ANSI Approved Approved

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.

Medical equipment
Biological analysis and testing
Toxicology
Toxicity
Degradation
Design
Metabolism
Absorption
Decomposition reactions
Leaching

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