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prEN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025)

General information

Draft
Base Documents
ISO/DIS 10993-16; prEN ISO 10993-16
Directives or regulations
None
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Standard history

Status
Date
Type
Name
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

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