PD 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 - General requirements, terms and definitions
In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - General requirements, terms and definitions
- Статус документа:
- D
- Формат:
- Электронный (PDF)
- Дата публикации:
- 31 декабря 2014 г.
- ICS:
- 01.040.19
- SKU:
- PD ISO/TS 17822-1:2014
Abstract
1 Scope This Technical Specification 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.
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