STN P CEN/TS 17626
| Označenie: | STN P CEN/TS 17626 |
| Platnosť: | Platná |
| Počet strán: | 40 |
| Jazyk: |
EN
|
| Listinná verzia: | 18,90€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
17,01€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 18,90€ c) S možnosťou tlače, prenosu textu a obrázkov: 24,57€ |
| Slovenský názov: | Molekulárno-diagnostické vyšetrenia in vitro. Špecifikácie postupov pred vyšetrením ľudskej vzorky. Izolovaná mikrobiómová DNA |
| Anglický názov: | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA |
| Dátum vydania: | 01. 09. 2021 |
| Dátum zrušenia: | |
| ICS: | 11.100.01 |
| Triediaci znak: | 85 6576 |
| Úroveň zapracovania: | idt CEN/TS 17626:2021 |
| Vestník: | 08/21 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | Táto predbežná STN je určená na overenie. Pripomienky zasielajte ÚNMS SR najneskôr do 19. 3. 2023. |
| Predmet normy: | This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). |
| Náhľad normy: | Náhľad normy (PDF) |