ISO/TS 17822-1:2014
In vitro diagnostic test systems -- Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens-- Part 1: General requirements, terms and definitions
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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.