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ÖNORM EN ISO 10993-16

Issue date: 2026 01 01

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

This document describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices and provides principles on designing and performing toxicokinetic evaluation relevant to medical devices.

General information on ÖNORM EN ISO 10993-16

Format
Paper | 31 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

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

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