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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.
Reģistrācijas numurs (WIID)
90994
Darbības sfēra
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.
