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ISO/TS 17822-1:2014 PDF

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

Название (английский):
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

Статус документа:
Отменён
Формат:
Электронный (PDF)
Количество страниц:
22
Дата публикации:
9 декабря 2014 г.
Издание:
ISO TS 17822 edition 1 version 1
ICS:
01.040.19
Описание (английский):

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.

Технические детали

Технический комитет
ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
SKU
ISO/TS 17822-1:2014