Lyhenteet

Verkkokauppa

Takaisin

CEN/TS 16826-3:2018:en

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

Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.

This document 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 examination 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.


Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sidokset
Velvoittavat viittaukset
EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
EN ISO/IEC 17020:2012
ISO 15190:2003 Medical laboratories -- Requirements for safety
Vahvistuspäivä
03.08.2018
Julkaisupäivä
07.08.2018
Painos
1
Sivumäärä
19
Julkaisun kieli
englanti

Takaisin