Abstract

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.

Begin

2023-11-14

WI

00206103

Planned document number

DIN EN ISO 10993-16

Project number

02703414

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 13 - Toxicokinetics  

draft standard

Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025); German and English version prEN ISO 10993-16:2025
2025-12
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previous edition(s)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
2018-02

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