Approved Work Item
ISO/AWI TS 25646
In vitro diagnostic medical devices — Definition of analytical performance specifications for laboratory measurements based on medical requirements
Reference number
ISO/AWI TS 25646
Edition 1
© ISO 2025
Approved Work Item
Under development
A working group has prepared a draft.

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 212
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
4
Quality Education

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