CEN/TS 16826-1:2015

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA

This Technical Specification recommends the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities).
RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues.
Therefore, special measures have to be taken to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.
Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in this document.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 1: Isolierte RNS

Diese Technische Spezifikation gibt Empfehlungen zur Handhabung, Dokumentation und Verarbeitung von aus gefrorenem Gewebe bestehendem und für die RNS Analyse vorgesehenem Untersuchungsmaterial während der präanalytischen Phase vor Beginn der molekularen Analyse. 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).
RNS Profile in Geweben können sich vor und nach der Probenahme erheblich verändern und dies je nach Spender/Patient in unterschiedlichem Maß.
Daher ist es wichtig, dass besondere Maßnahmen getroffen werden, um die beschriebenen Profilveränderungen und  modifikationen im Gewebe im Hinblick auf die anschließende RNS Analyse möglichst gering zu halten.
Gewebe, die vor dem Gefriervorgang einer chemischen Vorbehandlung zur Stabilisierung unterzogen wurden, sind nicht durch dieses Dokument abgedeckt.

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus à congélation rapide - Partie 1: ARN extrait

La présente Spécification technique fournit des recommandations pour la manipulation, la documentation et le traitement des échantillons de tissus primaires congelés destinés à l’analyse de l’ARN durant la phase préanalytique précédant la réalisation d’un essai moléculaire. La présente Spécification technique s’applique aux tests de diagnostic moléculaire in vitro (par exemple, laboratoires de diagnostic in vitro, clients de laboratoires, concepteurs et fabricants de tests de diagnostic in vitro, institutions et organisations commerciales de recherche biomédicale, biobanques et autorités réglementaires).
Les profils d'ARN dans les tissus peuvent considérablement changer avant et après le prélèvement et peuvent varier selon les tissus de différents donneurs/patients.
Il est donc essentiel de prendre des mesures particulières afin de réduire le plus possible les changements de profil décrits et les modifications dans le tissu décrits lors de l'analyse de l’ARN.
Le présent document ne couvre pas les tissus ayant subi un prétraitement de stabilisation chimique avant la congélation.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za hitro zamrznjena tkiva - 1. del: Izolirani RNK

Ta tehnična specifikacija vsebuje priporočila za obravnavo, dokumentiranje in obdelavo vzorcev zamrznjenih tkiv, namenjenih za analizo RNK med predanalizno fazo, preden se izvede molekularni preskus. 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 RNK v tkivih se lahko močno spremenijo pred zbiranjem in po njem ter se različno spremenijo pri tkivih različnih darovalcev/bolnikov.
Zato je treba sprejeti posebne ukrepe, da se zmanjšajo opisane spremembe profila v tkivu za nadaljnje analize RNK.
Tkiva, ki so pred zamrzovanjem prestala predobdelavo za kemično stabilizacijo, niso zajeta v tem dokumentu.

General Information

• Status: Withdrawn
• Publication Date: 11-Aug-2015
• Withdrawal Date: 18-Dec-2018
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 19-Dec-2018
• Ref Project: SIST-TS CEN/TS 16826-1:2015 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA

Relations

• Replaced By: EN ISO 20184-1:2018 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
• Effective Date: 05-Sep-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 16826-1:2015
01-oktober-2015
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DKLWUR]DPU]QMHQDWNLYDGHO,]ROLUDQL51.
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for snap frozen tissue - Part 1: Isolated RNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für gefrorenes Gewebe - Teil 1: Isolierte RNS
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus à congélation rapide - Partie 1: ARN extrait
Ta slovenski standard je istoveten z: CEN/TS 16826-1:2015
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST-TS CEN/TS 16826-1:2015 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 16826-1:2015

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SIST-TS CEN/TS 16826-1:2015

TECHNICAL SPECIFICATION
CEN/TS 16826-1

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
August 2015
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications for
pre-examination processes for snap frozen tissue - Part 1:
Isolated RNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren -
relatives aux processus préanalytiques pour les tissus à Spezifikationen für präanalytische Prozesse für
congélation rapide - Partie 1: ARN extrait schockgefrorene Gewebeproben - Teil 1: Isolierte RNS
This Technical Specification (CEN/TS) was approved by CEN on 6 July 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.





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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 16826-1:2015 E
worldwide for CEN national Members.

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SIST-TS CEN/TS 16826-1:2015
CEN/TS 16826-1:2015 (E)
Contents Page
European 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 tissue collection manual.7
5.1.1 Information about the primary sample donor .7
5.1.2 Information on the primary tissue sample .7
5.1.3 Information on the primary tissue sample processing .8
5.2 Transport requirements .
...