PD ISO/TS 17822-1:2014

This standard PD ISO/TS 17822-1:2014 In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens is classified in these ICS categories:

• 01.040.19 Testing (Vocabularies)
• 11.100.01 Laboratory medicine in general

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.