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PD ISO/TS 17822-1:2014
<i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions
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| Označení normy: | PD ISO/TS 17822-1:2014 |
| Počet stran: | 34 |
| Vydáno: | 2014-12-31 |
| ISBN: | 978 0 580 89200 4 |
| Status: | Standard |
DESCRIPTION
PD ISO/TS 17822-1:2014
This standard PD 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 is classified in these ICS categories:
- 01.040.19 Testing (Vocabularies)
- 11.100.01 Laboratory medicine in general
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.