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ISO TS 17822-1
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 - First Edition
Organization:
ISO - International Organization for Standardization
Year: 2014
Abstract: 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.
— 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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| contributor author | ISO - International Organization for Standardization | |
| date accessioned | 2017-09-04T18:45:41Z | |
| date available | 2017-09-04T18:45:41Z | |
| date copyright | 2014.12.15 | |
| date issued | 2014 | |
| identifier other | KHUOJFAAAAAAAAAA.pdf | |
| identifier uri | http://yse.yabesh.ir/std;quein=autho162sAF6D081DAC4/handle/yse/227064 | |
| description abstract | 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. | |
| language | English | |
| title | ISO TS 17822-1 | num |
| title | 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 - First Edition | en |
| type | standard | |
| page | 30 | |
| status | Active | |
| tree | ISO - International Organization for Standardization:;2014 | |
| contenttype | fulltext |