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ISO 10993-16:1997 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
standard by International Organization for Standardization, 09/01/1997
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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.