ISO/NP TS 20324

Generation of medical device extracts for chemical analysis to support toxicological risk assessment

General information

Current stage: 10.20 New project ballot initiated Feb 13, 2025

Originator: ISO

Owner: ISO/TC 194 Biological and clinical evaluation of medical devices

Type: Technical Specification

Scope

This document specifies procedures for the generation of medical device extracts for chemical characterization testing to support toxicological risk assessment. It supports the activities of EN ISO 10993-18:2020 that depend on chemical analysis of device extracts for chemical characterization.

Life cycle

NOW

IN_DEVELOPMENT
ISO/NP TS 20324
10.20 New project ballot initiated
Feb 13, 2025