Résumé

ISO/TS 17822-1:2014 is intended for

? IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and

? medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.

This part of ISO/TS 17822 does not apply to

? nucleic acid-based examinations that are not intended for in vitro diagnostic use, or

? quantitative nucleic acid-based in vitro diagnostic examination procedures.


Informations générales 

  • État actuel
     : Annulée
    Date de publication
     : 2014-12
  • Edition
     : 1
  • Comité technique
     : ISO/TC 212 Laboratoires de biologie médicale et systèmes de diagnostic in vitro
  • ICS
     :
    01.040.19 Essais (Vocabulaires)
    11.100.01 Médecine de laboratoire en général

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