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EVS-EN ISO 10993-16:2017

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

General information

Valid from 18.12.2017
Base Documents
ISO 10993-16:2017; EN ISO 10993-16:2017
Directives or regulations
None

Standard history

Status
Date
Type
Name
18.12.2017
Main
06.04.2010
Main
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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