SIST EN ISO 20838:2006
(Main)Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Requirements for amplification and detection for qualitative methods (ISO 20838:2006)
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Requirements for amplification and detection for qualitative methods (ISO 20838:2006)
Scope: This draft European Standard provides the overall framework of qualitative methods for detection of food borne pathogens using the polymerase chain reaction (PCR). It relates to the general requirements for the specific amplification of target nucleic acid sequences and the detection and confirmation of the identity of the amplified nucleic acid sequence. Guidelines, minimum requirements and performance characteristics described in the standard are intended to ensure that comparable and reproducible results are obtained in different laboratories. This draft standard has been established for food borne pathogens in or isolated from food and feed
matrices, but can also be applied to other matrices, for example environmental samples, and for the detection of non pathogenic microorganisms.
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR) zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Anforderungen an Amplifikation und Nachweis bei qualitativen Verfahren (ISO 20838:2006)
Diese Internationale Norm legt Rahmenbedingungen für die qualitativen Verfahren zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln mittels der Polymerase-Kettenreaktion (PCR) fest.
Sie bezieht sich auf die allgemeinen Anforderungen an die spezifische Amplifikation von Target-Nukleinsäuresequenzen und den Nachweis sowie die Bestätigung der Identität der amplifizierten Nukleinsäuresequenz.
Die in dieser Internationalen Norm genannten Anleitungen, Mindestanforderungen und Leistungskriterien dienen dazu sicherzustellen, dass in verschiedenen Laboratorien vergleichbare und reproduzierbare Ergebnisse erhalten werden.
Diese Internationale Norm dient zum Nachweis von pathogenen Mikroorganismen in Lebensmittel- und Futtermittelproben oder aus ihnen isolierten pathogenen Mikroorganismen. Sie kann jedoch auch bei anderen Matrices, wie z. B. Umweltproben oder zum Nachweis von anderen in Untersuchung befindlichen Mikroorganismen, angewendet werden.
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la détection des micro-organismes pathogenes dans les aliments - Exigences relatives a l'amplification et a la détection pour les méthodes qualitatives (ISO 20838:2006)
L'ISO 20838:2006 fournit le cadre de travail général des méthodes qualitatives pour la détection des micro-organismes pathogènes présents dans les aliments à l'aide de la réaction de polymérisation en chaîne (PCR).
Elle concerne les exigences générales relatives à l'amplification spécifique des séquences d'acide nucléique cible et à la détection et la confirmation de la nature de la séquence d'acide nucléique amplifiée.
Les lignes directrices, les exigences minimales et les caractéristiques de performances décrites dans l'ISO 20838:2006 visent à garantir l'obtention de résultats comparables et reproductibles dans des laboratoires différents.
L'ISO 20838:2006 a été conçue pour les micro-organismes pathogènes présents dans les aliments et les matrices alimentaires ou isolés de ces derniers, mais elle peut également s'appliquer à d'autres matrices, par exemple les échantillons environnementaux, ainsi que pour la détection d'autres micro-organismes.
Mikrobiologija živil in krme – Odkrivanje prisotnosti patogenih mikroorganizmov v živilih z metodo verižne reakcije s polimerazo (PCR) – Zahteve za povečanje in odkrivanje pri kvalitativnih metodah (ISO 20838:2006)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20838:2006
01-september-2006
0LNURELRORJLMDåLYLOLQNUPH±2GNULYDQMHSULVRWQRVWLSDWRJHQLKPLNURRUJDQL]PRYY
åLYLOLK]PHWRGRYHULåQHUHDNFLMHVSROLPHUD]R 3&5 ±=DKWHYH]DSRYHþDQMHLQ
RGNULYDQMHSULNYDOLWDWLYQLKPHWRGDK ,62
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the
detection of food-borne pathogens - Requirements for amplification and detection for
qualitative methods (ISO 20838:2006)
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR)
zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Anforderungen an
Amplifikation und Nachweis bei qualitativen Verfahren (ISO 20838:2006)
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la
détection des micro-organismes pathogenes dans les aliments - Exigences relatives a
l'amplification et a la détection pour les méthodes qualitatives (ISO 20838:2006)
Ta slovenski standard je istoveten z: EN ISO 20838:2006
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 20838:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 20838
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 07.100.30
English Version
Microbiology of food and animal feeding stuffs - Polymerase
chain reaction (PCR) for the detection of food-borne pathogens -
Requirements for amplification and detection for qualitative
methods (ISO 20838:2006)
Microbiologie des aliments - Réaction de polymérisation en Mikrobiologie von Lebensmitteln und Futtermitteln -
chaîne (PCR) pour la détection des micro-organismes Polymerase-Kettenreaktion (PCR) zum Nachweis von
pathogènes dans les aliments - Exigences relatives à pathogenen Mikroorganismen in Lebensmitteln -
l'amplification et à la détection pour les méthodes Anforderungen an Amplifikation und Nachweis bei
qualitatives (ISO 20838:2006) qualitativen Verfahren (ISO 20838:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20838:2006: E
worldwide for CEN national Members.
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EN ISO 20838:2006 (E)
Foreword
This document (EN ISO 20838:2006) 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 "Agricultural 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 October 2006, and conflicting national
standards shall be withdrawn at the latest by October 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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.
2
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INTERNATIONAL ISO
STANDARD 20838
First edition
2006-04-15
Microbiology of food and animal feeding
stuffs — Polymerase chain reaction
(PCR) for the detection of food-borne
pathogens — Requirements for
amplification and detection for qualitative
methods
Microbiologie des aliments — Réaction de polymérisation en chaîne
(PCR) pour la détection des micro-organismes pathogènes dans les
aliments — Exigences relatives à l'amplification et à la détection pour
les méthodes qualitatives
Reference number
ISO 20838:2006(E)
©
ISO 2006
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ISO 20838:2006(E)
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ii © ISO 2006 – All rights reserved
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ISO 20838:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Principle. 1
5 Reagents. 2
6 Apparatus and equipment . 3
7 Procedure. 4
8 Interpretation. 6
9 Performance. 6
10 Test report. 6
Bibliography . 7
© ISO 2006 – All rights reserved iii
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ISO 20838:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
ISO 20838 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 275, Food analysis — Horizontal methods, in collaboration with Technical Committee ISO/TC 34,
Food products, Subcommittee SC 9, Microbiology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
iv © ISO 2006 – All rights reserved
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ISO 20838:2006(E)
Introduction
The amplification and detection of target nucleic acid sequences is performed to determine whether certain
nucleic acid sequences are present or not in the test portion. This determination is relative to appropriate
controls and within the detection limits of the analytical method used and test portion analysed.
This International Standard describes the procedure used to detect food-borne microorganisms, including
pathogens, by analysing nucleic acids extracted from foodstuffs, feed and environmental samples, or from
cultures or cell suspensions prepared from the foodstuff. Appropriate procedures for sample preparation,
culturing of microorganisms and extraction of nucleic acids are described in ISO 20837.
The main focus of this International Standard is on PCR-based amplification methods. However, because of
the rapid rate of technological change in this area, other amplification technologies and detection methods
may be considered.
This International Standard is related to a series of standards and a Technical Specification under the general
title Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the detection of
food-borne pathogens
⎯ General requirements and definitions (ISO 22174)
⎯ Requirements for sample preparation for qualitative detection (ISO 20837)
⎯ Performance testing for thermal cyclers (ISO/TS 20836)
⎯ Requirements for amplification and detection for qualitative methods (ISO 20838)
The International Organization for Standardization (ISO) draws attention to the fact that it is claimed that
compliance with this document may involve the use of one or more patents concerning the PCR technology.
ISO takes no position concerning the evidence, validity and scope of these patent rights.
ISO has been informed that Applied Biosystems, Roche Molecular Systems, Inc. and F. Hoffman-La Roche
Ltd. hold patent rights concerning the PCR technology. The companies have assured ISO that they are willing
to negotiate licences under reasonable and non-discriminatory terms and conditions with applicants
throughout the world. In this respect, the statements of the holders of these patent rights are registered with
ISO. Information may be obtained from:
Licensing Department
Applied Biosystems
850 Lincoln Centre Drive
Foster City, CA 94404
USA
and
Roche Molecular Systems, Inc.
Licensing Department
1145 Atlantic Avenue
Alameda, CA 94501
USA
© ISO 2006 – All rights reserved v
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ISO 20838:2006(E)
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights other than those identified above. ISO shall not be held responsible for identifying any or all such patent
rights.
vi © ISO 2006 – All rights reserved
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INTERNATIONAL STANDARD ISO 20838:2006(E)
Microbiology of food and animal feeding stuffs — Polymerase
chain reaction (PCR) for the detection of food-borne
pathogens — Requirements for amplification and detection for
qualitative methods
WARNING — The use of this standard may involve hazardous materials, operations and equipment.
This standard does not purport to address all of the safety problems associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety and health practices and
determine the applicability of regulatory limitations prior to use.
1 Scope
This International Standard provides the overall framework for qualitative methods for the detection of food-
borne pathogens using the polymerase chain reaction (PCR).
It covers the gene
...
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