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ISO/AWI TS 25364-4

Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA) ISO/AWI TS 25364-4

General information

20.00   New project registered in TC/SC work programme   Sep 17, 2025

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

Technical Specification

Scope

This document establishes best practice recommendations for:
— processing extracts for instrumental analysis;
— recognizing and addressing compromised extracts.

This document can be used in conjunction with ISO 10993-18.

Life cycle

NOW

IN_DEVELOPMENT
ISO/AWI TS 25364-4
20.00 New project registered in TC/SC work programme
Sep 17, 2025




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