Projet final
Norme internationale
ISO/FDIS 5649
Laboratoires médicaux — Concepts et spécifications relatifs à la conception, au développement, à la mise en œuvre et à l’utilisation des tests développés en laboratoire
Numéro de référence
ISO/FDIS 5649
Edition 1
Projet final Norme internationale
ISO/FDIS 5649
81506
Projet au stade approbation.

Résumé

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.

Informations générales

  •  : Projet
    : Epreuve envoyée au secrétariat ou mise au vote du FDIS: 8 semaines [50.20]
  •  : 1
     : 35
  • ISO/TC 212
    11.100.10 
  • RSS mises à jour

Vous avez une question?

Consulter notre Aide et assistance