Tema de trabajo aprobado
ISO/AWI TS 21385
Guidance for emerging technologies intended for medical laboratory use
Reference number
ISO/AWI TS 21385
ISO/AWI TS 21385
Edition 1
© ISO 2024
Tema de trabajo aprobado
Resumen
This document provides general requirement and guidance on identification, design and development of emerging technologies with potential use in medical laboratories and their preparation for clinical use. This document is applicable to laboratories transitioning emerging technologies utilizing human samples into medical laboratory examinations for the purpose of providing information for the diagnosis, monitoring, management, prevention, and treatment of disease. This document does not apply to medical laboratory examinations undergoing validation at which point the technology has become an in-house (laboratory developed) test or in-vitro diagnostic medical device.
Informaciones generales
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Estado: En desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
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Edición: 1
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Comité Técnico :ISO/TC 212
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