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ISO/FDIS 10993-16

Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables

General information

50.00     Aug 17, 2026

ISO

ISO/TC 194

International Standard

11.100.20  

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 10993-16:2017

NOW

PROJECT
ISO/FDIS 10993-16
50.00 Final text received or FDIS registered for formal approval
Aug 17, 2026

National adoptions

naSRPS EN ISO 10993-16:2024  
ISS

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

40.60   Close of voting

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