ISO 10993-16:2017 PDF
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Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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.
Edition | 2017 |
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Standard Part No | 16 |
Published Date | 2017 |
Published By | International Standardization Organisation |
Page Count | 13 |