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CEN/TS 17390-2:2020

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA

This document gives guidelines on the handling, storage, processing and documentation of venous blood
specimens intended for the examination of human genomic DNA isolated from Circulating Tumor Cells (CTCs) 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. 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.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
DNA in pathogens present in blood is not covered by this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molekularanalytische in vitro diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben - Teil 2: Isolierte DNA

Dieses Dokument gibt Empfehlungen zur Handhabung, Lagerung, Verarbeitung und Dokumentation von Proben venösen Vollbluts, die für die Untersuchung der aus zirkulierenden Tumorzellen (CTCs) isolierten menschlichen DNA vorgesehen sind, während der präanalytischen Phase vor der Durchführung einer molekularen Analyse.
Dieses Dokument ist anwendbar auf molekulare in vitro diagnostische Untersuchungen, die in medizi-nischen Laboratorien durchgeführt werden, einschließlich vom Laboratorium selbst entwickelter Verfahren. Es ist darüber hinaus für die Verwendung durch Kunden von Laboratorien, Entwickler und Hersteller von In vitro Diagnostika, durch Biobanken, Institutionen und kommerzielle Organisationen, die biomedizinische Forschungen durchführen, sowie durch Arzneimittelagenturen bestimmt.
Dieses Dokument behandelt nicht die direkte Isolierung von genomischer DNA aus venösen Vollblutproben, die CTCs enthalten. Dies wird in EN ISO 20186 2, Molekularanalytische in vitro diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für venöse Vollblutproben — Teil 2: Isolierte genomische DNA, behandelt.
Dieses Dokument behandelt nicht die Isolierung von bestimmten weißen Blutzellen (Leukozyten) und die anschließende Isolierung von genomischer DNA aus diesen Zellen.
Dieses Dokument behandelt auch nicht die Anforderungen an den präanalytischen Arbeitsablauf zur Kryokonservierung und Kultivierung lebensfähiger CTCs.
ANMERKUNG 1 Die in diesem Dokument dargelegten Anforderungen können auch auf andere zirkulierende Zellen (z. B. fetale Zellen) angewendet werden.
ANMERKUNG 2 Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTCs) dans le sang total veineux - Partie 2: ADN extrait

Analyses de diagnostic moléculaire in vitro- Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTC) du sang total veineux - Partie 2 : ADN extrait

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za cirkulirajoče tumorske celice (CTC) v venski polni krvi - 2. del: Izolirana DNK

Ta dokument podaja smernice glede obravnave, shranjevanja, obdelave in dokumentiranja vzorcev venske krvi, namenjenih za analizo človeške genomske DNK, izolirane iz cirkulirajočih tumorskih celic (CTC) med predpreiskovalno fazo, preden se izvede molekularna preiskava. Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, ter regulativni organi. Ta dokument ne zajema izolacije določenih krvnih celic in nadaljnje izolacije genomske DNK iz njih. DNK v patogenih v krvi ni zajeta v tem dokumentu.
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Published
Publication Date
21-Jan-2020
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
22-Jan-2020
Due Date
28-Jan-2020
Completion Date
22-Jan-2020
Ref Project
SIST-TS CEN/TS 17390-2:2020 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA

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SLOVENSKI STANDARD
SIST-TS CEN/TS 17390-2:2020
01-marec-2020
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za cirkulirajoče tumorske celice (CTC) v venski polni krvi - 2. del: Izolirana
DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
Molekularanalytische in vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben
- Teil 2: Isolierte DNA
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les cellules tumorales circulantes (CTCs) dans le sang total veineux
- Partie 2: ADN extrait
Ta slovenski standard je istoveten z: CEN/TS 17390-2:2020
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17390-2:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 17390-2:2020

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SIST-TS CEN/TS 17390-2:2020


CEN/TS 17390-2
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

January 2020
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for circulating tumor cells
(CTCs) in venous whole blood - Part 2: Isolated DNA
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour les cellules tumorales circulantes (CTCs) dans le zirkulierende Tumorzellen (CTC) in venösen
sang total veineux - Partie 2: ADN extrait Vollblutproben - Teil 2: Isolierte DNA
This Technical Specification (CEN/TS) was approved by CEN on 27 October 2019 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17390-2:2020 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 17390-2:2020
CEN/TS 17390-2:2020 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General considerations . 10
5 Outside the laboratory . 10
5.1 Specimen collection . 10
5.2 Transport requirements.
...

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