PD ISO/TS 17822-1:2014 | 31 Dec 2014 | BSI Knowledge
Publication
PD ISO/TS 17822-1:2014
Invitro diagnostic test systems. Qualitative nucleic acid-based invitro examination procedures for detection and identification of microbial pathogens - General requirements, terms and definitions
Current, Under Review
•
Published:
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.