DANSK DS/ISO/TS 17822-1 PDF

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.