Projet de travail approuvé
ISO/AWI TS 25646
In vitro diagnostic medical devices — Definition of analytical performance specifications for laboratory measurements based on medical requirements
Numéro de référence
ISO/AWI TS 25646
ISO/AWI TS 25646
Edition 1
© ISO 2025
Projet de travail approuvé
Résumé
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.
Informations générales
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État actuel: ProjetStade: Nouveau projet enregistré au programme de travail du TC/SC [20.00]
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Edition: 1
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Comité technique :ISO/TC 212
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