ISO/TC 34/SC 9
| Project No. | ISO/TS 17822-1:2014 |
|---|---|
| Title | <p>ISO/TS 17822-1:2014 is intended for</p> <p>? 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</p> <p>? medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.</p> <p>This part of ISO/TS 17822 does not apply to</p> <p>? nucleic acid-based examinations that are not intended for in vitro diagnostic use, or</p> <p>? quantitative nucleic acid-based in vitro diagnostic examination procedures.</p> |
| Registration number (WIID) | 60601 |
| Scope | <p>ISO/TS 17822-1:2014 is intended for</p> <p>? 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</p> <p>? medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.</p> <p>This part of ISO/TS 17822 does not apply to</p> <p>? nucleic acid-based examinations that are not intended for in vitro diagnostic use, or</p> <p>? quantitative nucleic acid-based in vitro diagnostic examination procedures.</p> |
| Status | Atcelts |
| ICS group | 01.040.19 11.100.01 |