ISO 20184-3:2021

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA

Datum objavljivanja: 7. 5. 2021.

Опште информације

Trenutna faza: 60.60 Effective date: 7. 5. 2021.

Inicijator: ISO

Pripada: ISO/TC 212

Vrsta: Međunarodni standard

ICS: 11.100.10

Jezik: engleski francuski

Kupovina

Status: Objavljen

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Apstrakt

This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 20184-3:2021
60.60 Standard objavljen
7. 5. 2021.

Nacionalna preuzimanja

SRPS EN ISO 20184-3:2021

ISS

Molekularna in vitro dijagnostička ispitivanja – Specifikacije za procese pre ispitivanja za zamrznuto tkivo – Deo 3: Izolovana DNK

60.60 Standard objavljen

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