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

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.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für venöse Vollblutproben - Teil 1: Isolierte zelluläre RNS

Diese Technische Spezifikation gibt Empfehlungen zur Handhabung, Dokumentation und Verarbeitung von für die Analyse zellulärer RNS vorgesehenen venösen Vollblutproben während der präanalytischen Phase vor Beginn der molekularen Analyse. Diese Technische Spezifikation behandelt Untersuchungsmaterial, das mit Blutentnahmeröhrchen für venöses Vollblut entnommen wurde. Diese Technische Spezifikation gilt für molekulare in vitro diagnostische Untersuchungen (z. B. In vitro Diagnostik Labore, Kunden dieser Labore, Entwickler und Hersteller von In vitro Diagnostika, Einrichtungen und kommerzielle Organisationen, die in der biomedizinischen Forschung tätig sind, Biobanken und Aufsichtsbehörden).
Profile von  zellulärer RNS in Blutzellen können sich nach der Entnahme signifikant verändern. Daher müssen besondere Maßnahmen getroffen werden, um eine gute Qualität der Blutproben für die Analyse der zellulären RNS und die Lagerung sicherzustellen.
Zur Stabilisierung frei zirkulierender Blutzellen RNS und im Blut zirkulierender RNS in Exosomen müssen gesonderte Maßnahmen getroffen werden, die nicht in dieser Technischen Spezifikation beschrieben sind.
Für die Entnahme, die Stabilisierung, den Transport und die Lagerung von Kapillarblut sowie für die Entnahme und die Lagerung von Blut mit auf Papier basierenden Technologien müssen gesonderte Maßnahmen getroffen werden. Diese Maßnahmen sind nicht in dieser Technischen Spezifikation beschrieben.
Nicht durch diese Technische Spezifikation abgedeckt ist RNS in im Blut vorhandenen Pathogenen.

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang total veineux - Partie 1: ARN cellulaire extrait

La présente Spécification technique donne des recommandations pour la manipulation, la documentation et le traitement des spécimens de sang total veineux destinés à l’analyse de l’ARN cellulaire pendant la phase pré-analytique, avant d’effectuer un essai moléculaire. Elle concerne les spécimens collectés dans des tubes de prélèvement de sang total veineux. Elle est applicable aux tests de diagnostic moléculaire in vitro (par exemple laboratoires de diagnostic in vitro, clients de laboratoires, concepteurs et fabricants de tests de diagnostics in vitro, institutions et organisations commerciales travaillant dans la recherche biomédicale, les biobanques et les autorités réglementaires).
Les profils d’ARN cellulaire sanguin peuvent changer de manière significative après le prélèvement. Par conséquent, des mesures spécifiques doivent être prises pour assurer la bonne qualité des échantillons de sang en vue de l’analyse de l’ARN cellulaire et de son stockage.
Des mesures spécifiques, non décrites dans la présente Spécification technique, doivent être prises pour stabiliser l’ARN circulant et l’ARN des exosomes du sang.
Des mesures spécifiques doivent être prises pour prélever, stabiliser, transporter et stocker le sang capillaire, et pour prélever et stocker le sang par des technologies sur support papier. Ces mesures ne sont pas décrites dans la présente Spécification technique.
L’ARN des pathogènes présents dans le sang n’est pas couvert par la présente Spécification technique.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za vensko polno kri - 1. del: Izolirana celična RNA

Ta tehnična specifikacija vsebuje priporočila za obravnavo, dokumentiranje in obdelavo vzorcev venske polne krvi, namenjenih za analizo celične RNA med predanalizno fazo, preden se izvede molekularni preskus. Ta tehnična specifikacija zajema vzorce, ki so zbrani s cevkami za zbiranje venske polne krvi. Ta tehnična specifikacija se uporablja za molekularne diagnostične preiskave in vitro (npr. diagnostični laboratoriji in vitro, laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, biobanke ter regulativni organi).
Profili krvne celične RNA se lahko po odvzemu bistveno spremenijo. Zato je treba sprejeti posebne ukrepe za pridobivanje vzorcev krvi dobre kakovosti za analizo in shrambo celične RNA.
Sprejeti je treba različne namenske ukrepe za stabiliziranje krožeče RNA brez krvnih celic in RNA v eksosomih, ki kroži v krvi, kar ni opisano v tem tehničnem poročilu.
Sprejeti je treba različne namenske ukrepe za zbiranje, stabiliziranje, prevoz in shrambo kapilarne krvi ter za zbiranje in shrambo krvi s tehnologijami, ki temeljijo na papirju. To ni opisano v tej tehnični specifikaciji.
RNA v patogenih v krvi ni obravnavana v tej tehnični specifikaciji.

General Information

Status
Withdrawn
Publication Date
30-Jun-2015
Withdrawal Date
26-Mar-2019
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
27-Mar-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 16835-1:2015
01-september-2015
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DYHQVNRSROQRNULGHO,]ROLUDQDFHOLþQD51$
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 1: Isolated cellular RNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 1: Isolierte zelluläre RNS
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour le sang veineux total - Partie 1 : ARN cellulaire isolé
Ta slovenski standard je istoveten z: CEN/TS 16835-1:2015
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
11.100.30 Analiza krvi in urina Analysis of blood and urine
SIST-TS CEN/TS 16835-1:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TS CEN/TS 16835-1:2015

---------------------- Page: 2 ----------------------

SIST-TS CEN/TS 16835-1:2015

TECHNICAL SPECIFICATION
CEN/TS 16835-1

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
July 2015
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications for
pre-examination processes for venous whole blood - Part 1:
Isolated cellular RNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren -
relatives aux processus préanalytiques pour le sang Spezifikationen für präanalytische Prozesse für venöse
veineux total - Partie 1 : ARN cellulaire isolé Vollblutproben - Teil 1: Isolierte zelluläre RNS
This Technical Specification (CEN/TS) was approved by CEN on 30 May 2015 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16835-1:2015 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST-TS CEN/TS 16835-1:2015
CEN/TS 16835-1:2015 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 General considerations .6
5 Outside the laboratory .7
5.1 Primary venous whole blood collection manual .7
5.1.1 Information about the primary sample donor .7
5.1.2 Selection of the venous blood collection tube by the laboratory .7
5.1.3 Primary venous whole blood collection from the patient and stabilization procedures .
...

SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 16835-1:2015
01-april-2015
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DYHQR]QRNULSROQHVHVWDYHGHO3RVDPLþQLFHOLþQL51$
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 1: Isolated cellular RNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 1: Isolierte zelluläre RNS
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour le sang veineux total - Partie 1 : ARN cellulaire isolé
Ta slovenski standard je istoveten z: FprCEN/TS 16835-1
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
kSIST-TS FprCEN/TS 16835-1:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TS FprCEN/TS 16835-1:2015

---------------------- Page: 2 ----------------------
kSIST-TS FprCEN/TS 16835-1:2015

TECHNICAL SPECIFICATION
FINAL DRAFT
FprCEN/TS 16835-1
SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION

January 2015
ICS
English Version
Molecular in vitro diagnostic examinations - Specifications for
pre-examination processes for venous whole blood - Part 1:
Isolated cellular RNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren -
relatives aux processus préanalytiques pour le sang Spezifikationen für präanalytische Prozesse für venöse
veineux total - Partie 1 : ARN cellulaire isolé Vollblutproben - Teil 1: Isolierte zelluläre RNS


This draft Technical Specification is submitted to CEN members for formal vote. It has been drawn up by the Technical Committee CEN/TC
140.

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

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change without notice
and shall not be referred to as a Technical Specification.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 16835-1:2015 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
kSIST-TS FprCEN/TS 16835-1:2015
FprCEN/TS 16835-1:2015 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 General Considerations .6
5 Outside the laboratory .7
5.1 Primary venous whole blood collection manual .7
5.1.1 Information about the primary sample donor .7
5.1.2 Selection of the venous blood blood collection tube by the laboratory .7
5.1.3 Primary venous whole blood collection from the patient and stabilization procedures .7
5.1.4 Information on the primary blood sample and storage requirements at the blood
collection facility .
...

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