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.
État actuel: AnnuléeDate de publication: 2014-12
Comité technique: ISO/TC 212 Laboratoires de biologie médicale et systèmes de diagnostic in vitro