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ISO 20166-1:2018

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA
26. 11. 2018.

Опште информације

90.93     12. 12. 2024.

ISO

ISO/TC 212

Međunarodni standard

11.100.10  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 20166-1:2018
90.93 Odluka o potvrđivanju standarda
12. 12. 2024.

REVIDIRAN OD

PROJEKAT
ISO/PWI 20166-1

Nacionalna preuzimanja

SRPS EN ISO 20166-1:2019  
ISS

Molekularna in vitro dijagnostička ispitivanja – Specifikacije za procese pre ispitivanja za tkivo fiksirano u formalinu i ukalupljeno u parafinu (FFPE) – Deo 1: Izolovani RNK

60.60   Standard objavljen

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