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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) prEN ISO 10993-16

Publication date:   Dec 11, 2025

General information

45.99   Dispatch of FV draft to CCMC   Aug 31, 2026

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

This document describes the considerations to include the toxicokinetic evaluation of single chemical which can include its degradant or metabolite known to be released from a medical device. This document provides the principles for designing and performing a toxicokinetic evaluation for medical devices.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 10993-16:2017

NOW

IN_DEVELOPMENT
prEN ISO 10993-16
45.99 Dispatch of FV draft to CCMC
Aug 31, 2026




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