ISO/TS 17822-1:2014 Preview
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 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
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Status : PublishedPublication date : 2014-12
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Edition : 1Number of pages : 22
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- ICS :
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Testing (Vocabularies)
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Laboratory medicine in general
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ISO/TS 17822-1:2014
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