ISO TS 17822-1
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
|Publication Date:||15 December 2014|
|ICS Code (Testing (Vocabularies)):||01.040.19|
|ICS Code (Laboratory medicine in general):||11.100.01|
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.