Draft International Standard
ISO/DIS 5649
Medical laboratories — Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
Reference number
ISO/DIS 5649
Edición 1
Draft
International Standard
Vista previa
ISO/DIS 5649
81506
No disponible en español
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.

ISO/DIS 5649

ISO/DIS 5649
81506
Idioma
Formato
CHF 63
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Resumen

The proposed standard document specifies requirements for ensuring quality, safety and performance of laboratory-developed tests (LDT). It outlines the general principles and assessment criteria by which LDT shall be designed, developed, manufactured, validated and monitored for internal use by medical laboratories. While the proposed standard follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within certain disciplines of medical laboratory testing. This document does not cover requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-in-vitro-diagnostic purposes. However, the concepts presented in this document may also be useful for these institutions. The proposed standard does not apply to the design, development and industrial production of commercially used in vitro diagnostic medical devices.

Informaciones generales

  •  : En desarrollo
    : Cierre de la votación [40.60]
  •  : 1
     : 35
  • ISO/TC 212
    11.100.10 
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