EN 15842:2010
(Main)Foodstuffs - Detection of food allergens - General considerations and validation of methods
Foodstuffs - Detection of food allergens - General considerations and validation of methods
This European Standard specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they may be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von Verfahren
Diese Europäische Norm legt fest, wie die Normen zu Immunoassays, auf Nukleinsäuren basierenden und chromatographischen Verfahren anzuwenden sind, und deren Beziehung bei der Analyse von Lebensmittel-allergenen; sie enthält die allgemeinen Definitionen, Anforderungen an und Leitlinien für die Gestaltung von Laboratorien, Anforderungen an die Verfahrensvalidierung, Beschreibung der Verfahren und Untersuchungs-berichte.
Das vorliegende Dokument legt außerdem die allgemeinen Leitlinien für die Anforderungen und die Ver-wendung von Referenzmaterialien zur Bestimmung von allergenen Stoffen in Lebensmittelerzeugnissen fest. Der Begriff Referenzmaterial umfasst in diesem Dokument sowohl zertifizierte Referenzmaterialien als auch Qualitätskontrollmaterialien. Derzeit steht nur eine begrenzte Anzahl von Referenzmaterialien für die Bestimmung von Lebensmittelallergenen zur Verfügung. Wenn neue Materialien anerkannt und validiert wor¬den sind, dürfen sie als Anhang zu diesem Dokument hinzugefügt werden.
Das vorliegende Dokument beschäftigt sich nicht mit den Fragen der Probenahme. Es befasst sich lediglich im Einzelnen mit den vom Empfang der Laborprobe bis zum Endergebnis erforderlichen Prozessen.
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes
La présente Norme européenne explique comment utiliser les étalons des méthodes basées sur les immuno-essais, des méthodes chromatographiques et des méthodes basées sur l’acide nucléique, ainsi que leur relation dans l’analyse des allergènes alimentaires. Elle contient également les définitions générales, les exigences et les lignes directrices relatives aux éléments suivants : l’installation du laboratoire, les exigences en matière de validation de la méthode, la description des méthodes et les rapports d’essai.
Le présent document spécifie également les grandes lignes concernant les exigences et l’utilisation des matériaux de référence pour doser les produits allergènes dans les produits alimentaires. Le terme « matériaux de référence » tel qu’il est utilisé ici englobe les matériaux de référence certifiés ainsi que les matériaux de contrôle de qualité. À ce jour il n’existe qu’un nombre limité de matériaux de référence pour doser les allergènes alimentaires. Dès que de nouveaux matériaux sont acceptés et validés, ils peuvent être ajoutés sous forme d’annexes au présent document.
Le présent document ne traite pas des questions d’échantillonnage. Il détaille simplement les processus en jeu de la réception de l’échantillon pour laboratoire au résultat final.
Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija metod
Ta evropski standard opredeljuje, kako uporabljati standarde za imunske preskuse, metode na osnovi nukleinskih kislin inkromatografije in njihovo razmerje v analizi alergenov v živilih. Vsebuje splošne definicije, zahteve in smernice za postavitev laboratorija, zahteve za validacijo metode, opis metod in poročila o preskusih. Ta dokument tudi opredeljuje splošne smernice za zahteve in uporabo referenčnih materialov za določevanje alergenih proizvodov v živilskih proizvodih. Izraz "referenčni materiali" v tem dokumentu zajema certificirane referenčne materiale, kot tudi materiale za nadzor kakovosti. Trenutno je na voljo le omejeno število referenčnih materialov za določevanje alergenov v živilih. Ko bodo novi materiali sprejeti in validirani, so lahko dodani temu dokumentu kot Dodatek. Ta dokument ne obravnava vprašanj v zvezi z vzorčenjem. Podrobno navaja samo postopke od sprejema laboratorijskega vzorca do končnega rezultata.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija metodLebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von VerfahrenProduits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodesFoodstuffs - Detection of food allergens - General considerations and validation of methods67.050Splošne preskusne in analizne metode za živilske proizvodeGeneral methods of tests and analysis for food productsICS:Ta slovenski standard je istoveten z:EN 15842:2010SIST EN 15842:2010en,fr,de01-maj-2010SIST EN 15842:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15842
February 2010 ICS 67.050 English Version
Foodstuffs - Detection of food allergens - General considerations and validation of methods
Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes
Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von VerfahrenThis European Standard was approved by CEN on 25 December 2009.
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 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15842:2010: ESIST EN 15842:2010
(ISO/IEC 17025:2005) EN ISO 17511:2003, In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
(ISO 17511:2003) ISO Guide 31, Reference materials — Contents of certificates and labels ISO Guide 35, Reference materials — General and statistical principles for certification 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accepted reference value value that serves as an agreed-upon reference for comparison and which is derived as: theoretical or established value, based on scientific principles, an assigned value, based on experimental work of some national or international organization, consensus value, based on collaborative experimental work under the auspices of a scientific or engineering group [ISO Guide 30:1992] 3.2 accuracy closeness of agreement between a test result or measurement result and the true value SIST EN 15842:2010
NOTE 1 Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value. NOTE 2 The bias of a measuring instrument is normally estimated by averaging the error of indication over an appropriate number of repeated measurements. The error of indication is the "indication of a measuring instrument minus a true value of the corresponding input quantity". [ISO 3534-2:2006] 3.5 Certified Reference Material
CRM reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realisation of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence [ISO Guide 30:1992]
3.6 certified value for a CRM, value that appears in the certificate accompanying the material [ISO Guide 30:1992] 3.7 characterization for a reference material, determination of one or more physical, chemical, biological, or technological property values that are relevant to its intended end use
[ISO Guide 30:1992] 3.8 collaborative study interlaboratory study
interlaboratory study in which each laboratory uses a defined method of analysis to analyse identical portions of homogenous material to assess the performance characteristics obtained for the method of analysis
degree to which data produced by
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