SIST EN 15634-1:2019

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

This document 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 this document are intended to ensure that comparable and reproducible results are obtained in different laboratories. This document has been established for food matrices.

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

Dieses Dokument 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 diesem Dokument angeführten Leitlinien, Mindestanforderungen und Leistungskriterien sind dafür vorgesehen, sicherzustellen, dass in verschiedenen Laboratorien vergleichbare und reproduzierbare Ergebnisse erhalten werden. Dieses Dokument wurde für Lebensmittelmatrices erarbeitet.

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

Le présent document 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). Il 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 performances établis dans le présent document sont destinés à assurer que des laboratoires différents obtiendront des résultats comparables et reproductibles. Le présent document a été élaboré pour les matrices alimentaires.

Živila - Odkrivanje prisotnosti alergenov v živilih z molekularno biološkimi metodami - 1. del: Splošne ugotovitve

Ta dokument podaja splošen okvir za odkrivanje zaporedij v vrstah, ki vsebujejo alergene, s polimerazno verižno reakcijo (PCR). Navezuje se na zahteve za specifično povečanje ciljnih zaporedij nukleinske kisline (DNA) in za potrditev identitete povečanega zaporedja nukleinske kisline.
Smernice, minimalne zahteve in merila učinkovitosti iz tega dokumenta so namenjeni zagotavljanju, da se v različnih laboratorijih pridobijo primerljivi in ponovljivi rezultati. Ta dokument je bil pripravljen za zmesi živil.

General Information

• Status: Published
• Public Enquiry End Date: 09-Sep-2018
• Publication Date: 06-Nov-2019
• ICS: 07.100.30 - Food microbiology
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Oct-2019
• Due Date: 21-Dec-2019
• Completion Date: 07-Nov-2019
• Directive: 882/2004 - Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 onofficial controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
• Ref Project: EN 15634-1:2019 - Foodstuffs - Detection of food allergens by molecular biological methods - Part 1: General considerations

Relations

• Replaces: SIST EN 15634-1:2009 - Foodstuffs - Detection of food allergens by molecular biological methods - Part 1: General considerations
• Effective Date: 01-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 15634-1:2019
01-december-2019
Nadomešča:
SIST EN 15634-1:2009
Živila - Odkrivanje prisotnosti alergenov v živilih z molekularno biološkimi
metodami - 1. del: Splošne ugotovitve
Foodstuffs - Detection of food allergens by molecular biological methods - Part 1:
General considerations
Lebensmittel - Nachweis von Lebensmittelallergenen mit molekularbiologischen
Verfahren - Teil 1: Allgemeine Betrachtungen
Produits alimentaires - Détection des allergènes alimentaires par des méthodes
d’analyse de biologie moléculaire - Partie 1: Considérations générales
Ta slovenski standard je istoveten z: EN 15634-1:2019
ICS:
07.100.30 Mikrobiologija živil Food microbiology
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST EN 15634-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 15634-1:2019

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SIST EN 15634-1:2019


EN 15634-1
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2019
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes EN 15634-1:2009
English Version

Foodstuffs - Detection of food allergens by molecular
biological methods - Part 1: General considerations
Produits alimentaires - Détection des allergènes Lebensmittel - Nachweis von Lebensmittelallergenen
alimentaires par des méthodes d'analyse de biologie mit molekularbiologischen Verfahren - Teil 1:
moléculaire - Partie 1 : Considérations générales Allgemeine Betrachtungen
This European Standard was approved by CEN on 12 August 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC 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
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15634-1:2019 E
worldwide for CEN national Members.

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SIST EN 15634-1:2019
EN 15634-1:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General requirements for laboratories . 7
5 Procedure. 8
6 Isolation/Extraction of nucleic acid . 9
7 Amplification of specific target sequences . 10
8 Detection and confirmation of PCR products . 12
9 Interpretation . 13
10 Express
...