ISO/TS 17822-1:2014
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ISO/TS 17822-1:2014
60601

Тезис 

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.


Общая информация 

  •  :  Withdrawn
     : 2014-12
  •  : 1
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :
    01.040.19 Testing (Vocabularies)
    11.100.01 Laboratory medicine in general

Жизненный цикл


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