Résumé
This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT).
It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.
Prévisualiser
Prévisualiser cette norme sur notre Plateforme de consultation en ligne (OBP)
Informations générales
-
État actuel: PubliéeDate de publication: 2020-11
Version corrigée (en): 2020-12Stade: Norme internationale publiée [60.60] -
Edition: 1
-
Comité technique :ISO/TC 212ICS :11.100.01
- RSS mises à jour
Cycle de vie
-
Précédemment
AnnuléeISO/TS 17822-1:2014
-
Actuellement
Vous avez une question?
Consulter notre FAQ
Service à la clientèle
+41 22 749 08 88
Horaires d’ouverture:
De lundi à vendredi - 09:00-12:00, 14:00-17:00 (UTC+1)