ISO-10993-16 › Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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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.
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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
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ISO-10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Document Number
ISO 10993-16:2017
Revision Level
3RD EDITION
Status
Current
Publication Date
May 1, 2017
Committee Number
ISO/TC 194