ISO/TS 17822-1:2014 - $138.00   BUY NOW

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

ISO/TS 17822-1:2014 Publication Description:

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.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-01-Generalities ICS Vocabularies-Testing (01.040.19)
ICS-11-Health ICS Laboratory Medicine-General (11.100.01)

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