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ISO/CD TS 25646

In vitro diagnostic medical devices — Definition of analytical performance specifications for laboratory measurements based on medical requirements

General information

30.20     Apr 4, 2026

ISO

ISO/TC 212

Technical Specification

Scope

This technical specification (TS) describes the recommended approaches for defining analytical performance specifications (APS) in relationship to medical requirements, addresses the APS role in laboratory medicine, and how and in which scenarios APS need to be applied when a metrological traceability hierarchy as described in ISO 17511 is implemented. This TS applies to all in vitro diagnostic stakeholders for improving the quality and suitability of their contributions to patient care.

Life cycle

NOW

PROJECT
ISO/CD TS 25646
30.20 CD study/ballot initiated
Apr 4, 2026

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