CEN/TS 16827-1:2015
(Main)Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA
This Technical Specification gives recommendations for the handling, documentation and processing of FFPE 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, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the analytical test results.
Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für FFPE-Gewebeproben - Teil 1: Isolierte RNS
Diese Technische Spezifikation gibt Empfehlungen zur Handhabung, Dokumentation und Verarbeitung von aus FFPE 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).
Die Fixierung mit Formalin und die Einbettung in Paraffin können zu Modifikationen der RNS Moleküle führen, die sich auf die Gültigkeit und Zuverlässigkeit der Ergebnisse analytischer Prüfungen auswirken können.
Daher ist es wichtig, dass besondere Maßnahmen getroffen werden, um die beschriebenen Profil-veränderungen und modifikationen im Gewebe im Hinblick auf die anschließende RNS Analyse möglichst gering zu halten.
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus FFPE - Partie 1: ARN extrait
La présente Spécification technique fournit des recommandations pour la manipulation, la documentation et le traitement d’échantillons primaires de tissus FFPE 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 examens de diagnostic moléculaire in vitro (par exemple, laboratoires de diagnostic in vitro, clients de laboratoires, concepteurs et fabricants de diagnostic in vitro, institutions et organisations commerciales de recherche biomédicale, biobanques et autorités réglementaires).
Le processus de fixation au formol et d'inclusion en paraffine conduit à des modifications des molécules d'ARN, ce qui peut avoir un impact sur la validité et la fiabilité des résultats d'essais analytiques.
Il est donc essentiel de prendre des mesures spéciales afin de réduire le plus possible les changements de profil décrits et les modifications dans le tissu lors de l'analyse subséquente de l’ARN.
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za FFPE tkiva - 1. del: Izolirani RNK
Ta tehnična specifikacija vsebuje priporočila za obravnavo, dokumentiranje in obdelavo vzorcev tkiv FFPE, 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).
Fiksacija v formalinu in postopek vklopa v parafin vodita do sprememb molekul RNK, kar lahko vpliva na veljavnost in zanesljivost rezultatov analitičnih preskusov.
Zato je treba sprejeti posebne ukrepe, da se zmanjšajo opisane spremembe profila v tkivu za nadaljnje analize RNK.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN/TS 16827-1:2015
01-oktober-2015
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]D))3(WNLYDGHO ,]ROLUDQL51.
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for FFPE tissue - Part 1: Isolated RNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für FFPE-Gewebe - Teil 1: Isolierte RNS
Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour les tissus FFPE - Partie 1: ARN extrait
Ta slovenski standard je istoveten z: CEN/TS 16827-1:2015
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST-TS CEN/TS 16827-1:2015 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 16827-1:2015
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SIST-TS CEN/TS 16827-1:2015
TECHNICAL SPECIFICATION
CEN/TS 16827-1
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
August 2015
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications for
pre-examination processes for FFPE tissue - Part 1: Isolated
RNA
Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren -
relatives aux processus préanalytiques pour les tissus Spezifikationen für präanalytische Prozesse für FFPE-
FFPE - Partie 1: ARN extrait 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.
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 16827-1:2015 E
worldwide for CEN national Members.
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SIST-TS CEN/TS 16827-1:2015
CEN/TS 16827-1:2015 (E)
Contents Page
European foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 General considerations .7
5 Outside the laboratory .8
5.1 Primary tissue collection manual.8
5.1.1 Information about the primary sample donor .8
5.1.2 Information on the primary tissue sample .8
5.1.3 Information on the primary tissue sample processing .8
5.2 Transport requirements .
...
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