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Homepage>ISO Standards>ISO 10993-16:2017-Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables
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download between 0-24 hoursReleased: 2017
ISO 10993-16:2017-Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-16:2017

ISO 10993-16:2017-Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

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Standard´s number:ISO 10993-16:2017
Pages:13
Edition:3
Released:2017
DESCRIPTION

ISO 10993-16:2017


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.