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