Abstract
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: WithdrawnPublication date: 2014-12Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 22
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Technical Committee :ISO/TC 212
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Life cycle
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Now
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Revised by
PublishedISO 17822:2020