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.
| CSA Group | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | ISO/TS 17822-1:2014 |
| Product Name | 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 d... |
