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SRPS CEN/TS 16835-1:2016

Статус: Повучен
Језик: Engleski
Бр. страна: 20
Датум: 23.12.2016.
Датум повлачења: 31.07.2019 .
Службени гласник:
Број решења: 2917/70-51-02/2019
Издање: 1ED
Веза са међународним стандардима
Ovaj standard je identičan sa:
CEN/TS 16835-1:2015   CEN/TC 140
Цена: 2398 RSD

За читање онлајн

Одштампај

Наслов на српском језику

Molekularna in vitro dijagnostička ispitivanja – Specifikacije za prethodne ispitne procese pune venske krvi – Deo 1: Izolovani ćelijski RNK

Наслов на енглеском језику

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA

Апстракт на српском језику

Ova tehnička specifikacija preporučuje rukovanje, dokumentaciju i specifikacije za prethodno ispitne procese pune venske krvi

Апстракт на енглеском језику

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.

Комисија за стандарде


ICS



Директиве

Нема информација.

Национални пропис

Нема информација.

Национална активност



Белешке

Van plana


Дескриптори

in vitro, dijagnostička ispitivanja, krv, rukovanje