Norm

ISO/TS 17822-1:2014 en

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

98,05

Over deze norm

Status Definitief
Aantal pagina's 22
Commissie In vitro diagnostica
Gepubliceerd op 15-12-2014
Taal Engels
ISO/TS 27822-1 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.

Details

ICS-code 01.040.19
11.100.01
Nederlandse titel 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
Engelse titel 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

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