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About This Item
Full Description
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
Document History
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ISO 10993-16:2017
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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables- Most Recent
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ISO 10993-16:2010
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables- Historical Version
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ISO 10993-16:1997
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables- Historical Version