ISO/FDIS 10993-16

This draft is in the approval phase.

Will replace ISO 10993-16:2017

Abstract

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.

General information

Status
: Under development

Stage
: Final text received or FDIS registered for formal approval [50.00]
Edition
: 4
Technical Committee :
ISO/TC 194

ICS :
11.100.20
RSS updates