ISO/TS 17822-1:2014

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.