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 ISO/TS 17822-1:2014

Publication date:   Dec 9, 2014

Scope

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.