Это стандарт пересмотрен ISO 17822:2020
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
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Текущий статус : WithdrawnДата публикации : 2014-12
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Версия : 1
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- ICS :
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Testing (Vocabularies)
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Laboratory medicine in general
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