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)
ISO 20838:2006 provides the overall framework for qualitative methods for the detection of food-borne pathogens using the polymerase chain reaction (PCR).
It covers 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 ISO 20838:2006 are intended to ensure that comparable and reproducible results are obtained in different laboratories.
ISO 20838:2006 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, or to the detection of other microorganisms under investigation.
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 pathogènes dans les aliments - Exigences relatives à l'amplification et à 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
- Status
- Withdrawn
- Publication Date
- 14-Apr-2006
- Withdrawal Date
- 13-Apr-2025
- Technical Committee
- CEN/TC 463 - Microbiology of the food chain
- Drafting Committee
- CEN/TC 463/WG 1 - General requirements relating to PCR methods
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 04-Sep-2024
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 23-Oct-2024
Frequently Asked Questions
EN ISO 20838:2006 is a standard published by the European Committee for Standardization (CEN). Its full title is "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)". This standard covers: ISO 20838:2006 provides the overall framework for qualitative methods for the detection of food-borne pathogens using the polymerase chain reaction (PCR). It covers 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 ISO 20838:2006 are intended to ensure that comparable and reproducible results are obtained in different laboratories. ISO 20838:2006 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, or to the detection of other microorganisms under investigation.
ISO 20838:2006 provides the overall framework for qualitative methods for the detection of food-borne pathogens using the polymerase chain reaction (PCR). It covers 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 ISO 20838:2006 are intended to ensure that comparable and reproducible results are obtained in different laboratories. ISO 20838:2006 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, or to the detection of other microorganisms under investigation.
EN ISO 20838:2006 is classified under the following ICS (International Classification for Standards) categories: 07.100.30 - Food microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 20838:2006 has the following relationships with other standards: It is inter standard links to EN ISO 22174:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 20838:2006 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2006
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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.
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
ISO 20838:2006(E)
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ii © ISO 2006 – All rights reserved
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 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
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 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
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
...
EN ISO 20838:2006 표준은 식품 및 동물 사료의 미생물학과 관련하여 폴리머라제 연쇄 반응(PCR)을 이용한 식품 유래 병원체의 검출을 위한 질적 방법의 전체적인 프레임워크를 제공합니다. 이 표준은 목표 핵산 서열의 특별한 증폭 및 증폭된 핵산 서열의 정체성을 검출하고 확인하는데 필요한 일반 요구 사항을 포괄합니다. ISO 20838:2006에서 제공하는 가이드라인, 최소 요구 사항 및 성능 특성은 서로 다른 실험실에서 비교 가능하고 재현 가능한 결과를 보장하기 위해 설정되었습니다. 이러한 특성은 식품 유래 병원체의 검출을 위한 표준화된 접근 방식을 가능하게 하여, 연구자와 검사 담당자들이 동일한 기준으로 실험을 수행할 수 있도록 합니다. 이 표준은 식품 및 사료 매트릭스에서 분리된 식품 유래 병원체에 적용되도록 설계되었지만, 환경 샘플과 같은 다른 매트릭스나 조사가 진행 중인 다른 미생물의 검출에도 적용될 수 있습니다. 이러한 점에서 ISO 20838:2006은 다양한 분야에서 유용하며, 특히 식품 안전 및 품질 관리를 중요시하는 현대 사회의 요구에 부합합니다. 결과적으로, EN ISO 20838:2006은 식품 유래 병원체의 감지 및 확인에 있어 중요한 기준을 제공하며, 다양한 환경에서의 적용 가능성 덕분에 미생물 검출 분야에서 그 중요성이 더욱 강조됩니다. 이 표준은 검사 및 연구의 신뢰성과 정확성을 높이는 데 크게 기여할 것입니다.
Die Norm EN ISO 20838:2006 bietet einen umfassenden Rahmen für qualitative Methoden zur Erkennung von lebensmittelbedingten Krankheitserregern mithilfe der Polymerase-Kettenreaktion (PCR). Die Reichweite dieser Norm ist bemerkenswert, da sie spezifische Anforderungen für die gezielte Amplifikation von Nukleinsäuresequenzen und deren Identifikation beschreibt. Dies ist von zentraler Bedeutung für die Genaugkeit der Testergebnisse. Ein herausragendes Merkmal der ISO 20838:2006 ist ihre Fokussierung auf die Gewährleistung vergleichbarer und reproduzierbarer Ergebnisse in unterschiedlichen Laboratorien. Die in diesem Dokument beschriebenen Richtlinien und Mindestanforderungen sind entscheidend, um die Qualität und Zuverlässigkeit der durchgeführten Tests zu sichern. Dies fördert nicht nur das Vertrauen in die Testergebnisse, sondern unterstützt auch deren Anwendung in verschiedenen Kontexten, sei es in der Lebensmittelindustrie oder in der Tierernährung. Die Norm ist primär für lebensmittelbedingte Krankheitserreger vorgesehen, die in oder aus Lebensmittel- und Futtermittelmatrizen isoliert werden, weist jedoch auch eine breite Anwendbarkeit auf andere Matrizen auf. Dies schließt beispielsweise Umweltproben ein und ermöglicht die Detektion anderer untersuchter Mikroorganismen, was die Flexibilität und Relevanz der Norm in verschiedenen wissenschaftlichen und industriellen Bereichen erhöht. Insgesamt bietet die Norm EN ISO 20838:2006 nicht nur eine solide Grundlage für die PCR-basierte Detektion von Krankheitserregern, sondern erfüllt auch essentielle Anforderungen an die Qualitätssicherung und die reibungslose Durchführung von Tests in verschiedenen Laborumgebungen. Die Stärkung der Standards in der Mikrobiologie von Lebensmitteln ist entscheidend, um die Lebensmittelsicherheit zu gewährleisten und öffentliche Gesundheit zu fördern.
The EN ISO 20838:2006 standard is a crucial document in the realm of food safety, focusing on the microbiology of food and animal feeding stuffs through advanced methodologies such as polymerase chain reaction (PCR). Its scope is well-defined, providing a comprehensive framework for qualitative methods specifically aimed at detecting food-borne pathogens. The standard delineates the essential requirements for the precise amplification of target nucleic acid sequences, ensuring that laboratories can reliably detect and confirm the identity of these sequences. A significant strength of ISO 20838:2006 lies in its thorough guidelines and clearly outlined minimum requirements, which are designed to foster comparable and reproducible results across different laboratory settings. This focus on consistency is vital in the food industry, where accurate pathogen detection is essential for consumer safety and public health. Moreover, while the primary application is centered around food-borne pathogens in food and feed matrices, the standard's flexibility allows it to be applicable to a broader range of contexts. This includes environmental samples and the detection of other microorganisms that are under investigation, thus widening its relevance in microbiological testing. The performance characteristics described in ISO 20838:2006 are instrumental in ensuring that laboratories adhere to high standards of quality and reliability in their testing processes. This aspect of the standard underscores its importance as a tool not only for food safety but also for advancing the overall field of microbiological research and testing. Furthermore, the standard aligns with global practices in food safety, making it an invaluable resource for laboratories aiming to comply with international regulations and maintain high standards of quality assurance. In summary, EN ISO 20838:2006 stands out for its robust framework and adaptability, ensuring that it remains a relevant and vital document in the continued fight against food-borne pathogens and the promotion of safe food practices.
La norme EN ISO 20838:2006 constitue un cadre essentiel pour la détection des agents pathogènes d'origine alimentaire à l'aide de la méthode de réaction en chaîne par polymérase (PCR). Son champ d'application est bien défini, se concentrant sur les méthodes qualitatives pour l'amplification et la détection des séquences d'acides nucléiques cibles. Cette norme met en avant les exigences générales nécessaires pour la spécificité de l'amplification, garantissant ainsi que les résultats obtiennent une comparable exactitude et une reproductibilité dans différents laboratoires. Les lignes directrices, les exigences minimales ainsi que les caractéristiques de performance décrites dans la norme ISO 20838:2006 sont cruciales pour assurer la fiabilité et la validité des résultats dans l'analyse microbiologique. En outre, cette norme se révèle pertinente non seulement pour les pathogènes d'origine alimentaire présents dans les matrices alimentaires et les aliments pour animaux, mais elle peut également être appliquée à d'autres matrices telles que les échantillons environnementaux. Un des points forts de la norme est son adaptabilité ; bien qu'elle vise principalement les pathogènes d'origine alimentaire, la possibilité d'appliquer ces méthodes à d'autres micro-organismes en cours d'investigation enrichit considérablement la portée de son utilisation. Ainsi, la norme EN ISO 20838:2006 joue un rôle fondamental dans la sécurité alimentaire et dans la surveillance des pathogènes, assurant que les laboratoires peuvent détecter de manière efficace et précise les contaminations potentielles. En somme, la norme représente un outil puissant pour les professionnels de la microbiologie, visant à maintenir l'intégrité et la sécurité dans l'industrie alimentaire.
ISO 20838:2006は、食品や飼料中の病原微生物を特定するためのポリメラーゼ連鎖反応（PCR）による定性的手法の全体的な枠組みを提供します。この規格は、特定のターゲット核酸配列の増幅に関する一般的な要件と、増幅された核酸配列の識別と確認に関する要件を網羅しており、定性的手法の信頼性を保証します。 この規格の強みは、異なるラボで比較可能かつ再現可能な結果を得るための最低要件や性能特性が明確に定義されている点にあります。これにより、ISO 20838:2006に従った試験は、さまざまな環境においても同様の信頼性を持つ結果を生成することができます。 ISO 20838:2006は、食品や飼料マトリックスから分離された食品由来の病原体に特化していますが、環境サンプルや他の微生物の検出にも応用可能であるため、その適用範囲は非常に広いと言えます。この柔軟性は、食品安全や公共衛生の分野において重要な役割を果たしており、研究者や業界の専門家にとって欠かせないリソースとなっています。 したがって、ISO 20838:2006は、食品業界における病原体検出の信頼性と精度を向上させるための重要な基準として、その関連性と重要性が高いと言えるでしょう。
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