SIST EN ISO 15216-1:2017

Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus using real-time RT-PCR - Part 1: Method for quantification (ISO 15216-1:2017)

This document specifies a method for the quantification of levels of HAV and norovirus genogroup I
(GI) and II (GII) RNA, from test samples of foodstuffs (soft fruit, leaf, stem and bulb vegetables, bottled
water, BMS) or food surfaces. Following liberation of viruses from the test sample, viral RNA is then
extracted by lysis with guanidine thiocyanate and adsorption on silica. Target sequences within the
viral RNA are amplified and detected by real-time RT-PCR.
This method is not validated for detection of the target viruses in other foodstuffs (including multicomponent
foodstuffs), or any other matrices, nor for the detection of other viruses in foodstuffs, food
surfaces or other matrices.

Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zur Bestimmung von Hepatitis A-Virus und Norovirus mittels Real-time-RT-PCR - Teil 1: Verfahren zur Quantifizierung (ISO 15216-1:2017)

In diesem Teil von ISO 15216 wird ein Verfahren zur quantitativen Bestimmung des Gehalts an RNS von HAV und NoV der Genogruppen I (GI) und II (GII) in Untersuchungsproben von Lebensmitteln (Weichobst, Salat, in Flaschen abgefülltes Trinkwasser, zweischalige Weichtiere (Muscheln)) oder Lebensmitteloberflächen beschrieben. Nach der Freisetzung der Viren aus der Untersuchungsprobe wird die virale RNS durch Aufschluss des Viruskapsids mit Guanidinthiocyanat und Adsorption an Silica(-Partikel) extrahiert. Die Zielsequenzen innerhalb der viralen RNS werden amplifiziert und mittels Real-time RT-PCR nachgewiesen.
Dieses Verfahren ist weder für den Nachweis der Zielviren in anderen Lebensmitteln (einschließlich zusammengesetzter Lebensmittel) oder anderen Matrices noch für den Nachweis anderer Viren in Lebensmitteln, auf Lebensmitteloberflächen oder anderen Matrices validiert.

Microbiologie dans la chaine alimentaire - Méthode horizontale pour la recherche des virus de l'hépatite A et norovirus par la technique RT-PCR en temps réel - Partie 1: Méthode de quantification (ISO 15216-1:2017)

ISO 15216-1:2017 décrit une méthode de quantification des niveaux d'ARN de VHA et norovirus des génogroupes I (GI) et II (GII) présents dans des échantillons pour essai d'aliments (fruits tendres, légumes feuilles, tiges et bulbes, eau embouteillée, MBV) ou sur des surfaces alimentaires. Après libération des virus contenus dans l'échantillon pour essai, l'ARN viral est extrait par lyse à l'aide de thiocyanate de guanidine et par adsorption sur silice. Les séquences cibles de l'ARN viral sont amplifiées et détectées par la technique RT-PCR en temps réel.
Cette méthode n'est pas validée pour la détection des virus ciblés dans d'autres aliments (y compris les aliments à plusieurs composants) ou d'autres matrices, ni pour la détection d'autres virus dans les aliments, sur les surfaces alimentaires ou dans d'autres matrices.

Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje virusa hepatitisa A in norovirusov z RT-PCR v realnem času - 1. del: Metoda za kvantifikacijo (ISO 15216-1:2017)

Ta dokument določa kvantitativno metodo za določevanje ravni genske skupine virusa hepatitisa A in norovirusa I (GI) in II (GII) RNK v vzorcih ali živilih (mehkem sadju, listnati in stebelni zelenjavi, čebulnicah, ustekleničeni vodi, BMS) oz. na površinah živil. Po sprostitvi virusov iz vzorca se nato virusni RNK odstrani z lizo z gvanidinijevim tiocianatom in adsorpcijo na silicijev oksid. Ciljna zaporedja v virusni RNK poudari in zazna RT-PCR v realnem času.
Ta metoda ni potrjena za odkrivanje ciljnih virusov v drugih živilih (vključno z večkomponentnimi živili) ali drugih matricah ali odkrivanje drugih virusov v živilih, na površinah živil ali drugih matricah.

General Information

• Status: Published
• Public Enquiry End Date: 29-Oct-2015
• Publication Date: 16-May-2017
• ICS: 07.100.30 - Food microbiology
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Apr-2017
• Due Date: 30-Jun-2017
• Completion Date: 17-May-2017
• 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
• Mandate: M/381 - Mandate for standardisation addressed to CEN in the field of Methods of analysis of foodstuffs concerning Food Hygiene
• Ref Project: EN ISO 15216-1:2017 - Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus using real-time RT-PCR - Part 1: Method for quantification (ISO 15216-1:2017)

Relations

• Replaces: SIST-TS CEN ISO/TS 15216-1:2013 - Microbiology of food and animal feed - Horizontal method for determination of hepatitis A virus and norovirus in food using real-time RT-PCR - Part 1: Method for quantification (ISO/TS 15216-1:2013, Corrected Version 2013-05-01)
• Effective Date: 08-Jun-2022
• Replaces: SIST-TS CEN ISO/TS 15216-1:2013 - Microbiology of food and animal feed - Horizontal method for determination of hepatitis A virus and norovirus in food using real-time RT-PCR - Part 1: Method for quantification (ISO/TS 15216-1:2013, Corrected Version 2013-05-01)
• Effective Date: 01-Jun-2017
• Amended By: SIST EN ISO 15216-1:2017/A1:2021 - Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus using real-time RT-PCR - Part 1: Method for quantification - Amendment 1 (ISO 15216-1:2017/Amd 1:2021)
• Effective Date: 01-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15216-1:2017
01-junij-2017
1DGRPHãþD
SIST-TS CEN ISO/TS 15216-1:2013
0LNURELRORJLMDYSUHKUDQVNLYHULJL+RUL]RQWDOQDPHWRGD]DXJRWDYOMDQMHYLUXVD
KHSDWLWLVD$LQQRURYLUXVRY]573&5YUHDOQHPþDVXGHO0HWRGD]D
NYDQWLILNDFLMR,62
Microbiology of the food chain - Horizontal method for determination of hepatitis A virus
and norovirus using real-time RT-PCR - Part 1: Method for quantification (ISO 15216-
1:2017)
Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zur Bestimmung von
Hepatitis A-Virus und Norovirus mittels Real-time-RT-PCR - Teil 1: Verfahren zur
Quantifizierung (ISO 15216-1:2017)
Microbiologie dans la chaine alimentaire - Méthode horizontale pour la recherche des
virus de l'hépatite A et norovirus par la technique RT-PCR en temps réel - Partie 1:
Méthode de quantification (ISO 15216-1:2017)
Ta slovenski standard je istoveten z: EN ISO 15216-1:2017
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 15216-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15216-1:2017

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SIST EN ISO 15216-1:2017


EN ISO 15216-1
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2017
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes CEN ISO/TS 15216-1:2013
English Version

Microbiology of the food chain - Horizontal method for
determination of hepatitis A virus and norovirus using
real-time RT-PCR - Part 1: Method for quantification (ISO
15216-1:2017)
Microbiologie dans la chaine alimentaire - Méthode Mikrobiologie der Lebensmittelkette - Horizontales
horizontale pour la recherche des virus de l'hépatite A Verfahren zur Bestimmung von Hepatitis A-Virus und
et norovirus par la technique RT-PCR en temps réel - Norovirus mittels Real-time-RT-PCR - Teil 1: Verfahren
Partie 1: Méthode de quantification (ISO 15216- zur Quantifizierung (ISO 15216-1:2017)
1:2017)
This European Standard was approved by CEN on 23 February 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15216-1:2017 E
worldwide for CEN national Members.

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SIST EN ISO 15216-1:2017
EN ISO 15216-1:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 15216-1:2017
EN ISO 15216-1:2017 (E)
European foreword
This document (EN ISO 15216-1:2017) has been prepared by Technical Committee CEN/TC 275 “Food
analysis - Horizontal methods”, the secretariat of which is held by DIN, in collaboration with Technical
Committee ISO/TC 34 "Food products".
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2017 and conflicting national standards
shall be withdrawn at the latest by September 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes CEN ISO/TS 15216-1:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countrie
...