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ISO 10993-16:2017
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
SKU: iso_064582_162073
Published by ISO
Publication Year 2017
3 Edition
13 pages
Product Details
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.