Ссылочный номер
ISO/TS 17822-1:2014
© ISO 2024
Технические спецификации
ISO/TS 17822-1:2014
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
Версия 1
2014-12
В время отменен
Отозвано (Версия 1, 2014)

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

  • Текущий статус
     : Отозвано
    Дата публикации
     : 2014-12
    Этап
    : Отмена международного стандарта [95.99]
  • Версия
     : 1
  • Технический комитет :
    ISO/TC 212
  • RSS обновления

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