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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.


General information

  • Status :  Published
    Publication date : 2014-12
  • Edition : 1
    Number of pages : 22
  • Technical Committee
    :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • ICS :
    01.040.19
    Testing (Vocabularies)
    11.100.01
    Laboratory medicine in general

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Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

  • Now confirmed
    ISO/TS 17822-1:2014

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