<i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens - General requirements, terms and definitions

In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - General requirements, terms and definitions

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1   Scope

This Technical Specification 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.