Foodstuffs - Detection of food allergens by molecular biological methods - Part 1: General considerations

This European Standard provides the overall framework for detection of sequences corresponding to species containing allergens using the polymerase chain reaction (PCR). It relates to the requirements for the specific amplification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified nucleic acid sequence.
Guidelines, minimum requirements and performance criteria laid down in the European Standard are intended to ensure that comparable and reproducible results are obtained in different laboratories. This European Standard has been established for food matrices.

Lebensmittel - Nachweis von Lebensmittelallergenen mit molekularbiologischen Verfahren - Teil 1: Allgemeine Betrachtungen

Diese Europäische Norm legt den Gesamtrahmen für den Nachweis von Sequenzen, die Arten entsprechen, die Allergene enthalten, durch Polymerase-Kettenreaktion (PCR) fest. Er bezieht sich auf die Anforderungen an die spezifische Amplifikation von Target-Nukleinsäuresequenzen (DNA) und an die Bestätigung der Identi-tät der amplifizierten Nukleinsäuresequenz.
Die in dieser Europäischen Norm angeführten Leitlinien, Mindestanforderungen und Leistungskriterien sind dafür vorgesehen, sicherzustellen, dass in verschiedenen Laboratorien vergleichbare und reproduzierbare Ergebnisse erhalten werden. Diese Europäische Norm wurde für Lebensmittelmatrices erarbeitet.

Produits alimentaires - Détection des allergènes alimentaires par des méthodes d'analyse de biologie moléculaire - Partie 1: Considérations générales

La présente Norme européenne fournit un cadre général pour la détection des séquences correspondant aux espèces qui contiennent des allergènes, à l’aide de la méthode d’amplification en chaîne par polymérase (méthode PCR). Elle traite des exigences requises pour l’amplification spécifique de séquences cibles d’acide nucléique (ADN) et la confirmation de l’identité de la séquence d’acide nucléique amplifiée.
Les lignes directrices, les exigences minimales et les critères de performance établis dans la présente Norme européenne sont destinés à assurer que des laboratoires différents obtiendront des résultats comparables et reproductibles. La présente Norme européenne a été élaborée pour les matrices alimentaires.

Živila - Odkrivanje prisotnosti alergenov v živilih z metodami molekularne biologije - 1. del: Splošne ugotovitve

General Information

Status
Withdrawn
Publication Date
13-Jan-2009
Withdrawal Date
01-Oct-2019
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
02-Oct-2019

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Živila - Odkrivanje prisotnosti alergenov v živilih z metodami molekularne biologije - 1. del: Splošne ugotovitveLebensmittel - Nachweis von Lebensmittelallergenen mit molekularbiologischen Verfahren - Teil 1: Allgemeine BetrachtungenProduits alimentaires - Méthodes d'analyse de biologie moléculaire pour la détection des allergènes alimentaires - Partie 1 : Considérations généralesFoodstuffs - Detection of food allergens by molecular biological methods - Part 1: General considerations67.050Splošne preskusne in analizne metode za živilske proizvodeGeneral methods of tests and analysis for food products07.100.30Mikrobiologija živilFood microbiologyICS:Ta slovenski standard je istoveten z:EN 15634-1:2009SIST EN 15634-1:2009en,fr,de01-maj-2009SIST EN 15634-1:2009SLOVENSKI
STANDARD



SIST EN 15634-1:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15634-1January 2009ICS 07.100.30; 67.050 English VersionFoodstuffs - Detection of food allergens by molecular biologicalmethods - Part 1: General considerationsProduits alimentaires - Détection des allergènesalimentaires par des méthodes d'analyse de biologiemoléculaire - Partie 1: Considérations généralesLebensmittel - Nachweis von Lebensmittelallergenen mitmolekularbiologischen Verfahren - Teil 1: AllgemeineBetrachtungenThis European Standard was approved by CEN on 1 December 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15634-1:2009: ESIST EN 15634-1:2009



EN 15634-1:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Terms and definitions .54General laboratory requirements .75Procedure .86Isolation / Extraction of nucleic acid .87Amplification of specific target sequences .98Detection and confirmation of PCR products . 129Interpretation . 1210Expression of the results . 1311Test report . 14Bibliography . 15 SIST EN 15634-1:2009



EN 15634-1:2009 (E) 3 Foreword This document (EN 15634-1:2009) has been prepare
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