Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Nucleic acid extraction (ISO 21571:2005)

ISO 21571:2005 provides general requirements and specific methods for DNA extraction/purification and quantification. These methods are described in Annexes A and B.
ISO 21571:2005 has been established for food matrices, but could also be applicable to other matrices, such as grains and feed.
It has been designed as an integral part of nucleic-acid-based analytical methods, in particular ISO 21569 on qualitative analytical methods, and ISO 21570 on quantitative analytical methods.

Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Nukleinsäureextraktion (ISO 21571:2005)

Diese Internationale Norm legt allgemeine Anforderungen an und spezifische Verfahren für die Extraktion/Reinigung von DNA und die quantitative Bestimmung fest. Diese Verfahren sind in den Anhängen A und B beschrieben.
Diese Internationale Norm wurde für Lebensmittelmatrices erarbeitet, könnte jedoch mit einigen Anpassungen auch auf andere Matrices wie Getreide und Futtermittel angewendet werden.
Diese Norm wurde als ein integraler Bestandteil von auf Nukleinsäuren basierenden analytischen Verfahren, insbesondere ISO 21569 zu qualitativen analytischen Verfahren und ISO 21570 zu quantitativen analytischen Verfahren erarbeitet.

Produits alimentaires - Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés - Extraction des acides nucléiques (ISO 21571:2005)

L'ISO 21571:2005 indique les exigences générales et les méthodes spécifiques pour l'extraction, la purification et la quantification de l'ADN. Ces méthodes sont décrites dans les Annexes A et B..
L'ISO 21571:2005 a été élaborée pour les matrices alimentaires, mais peut également s'appliquer à d'autres matrices (par exemple grains et aliments pour animaux).
Elle a été conçue dans le cadre d'une série de méthodes d'analyse fondées sur l'utilisation de l'acide nucléique, notamment l'ISO 21569 (méthodes d'analyse qualitative) et l'ISO 21570 (méthodes d'analyse quantitative).

Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov - Izolacija nukleinskih kislin (ISO 21571:2005

Ta mednarodni standard določa splošne zahteve in posebne metode za izolacijo/purifikacijo in kvantifikacijo DNK. Te metode so opisane v dodatkih A in B. Ta mednarodni standard je bil pripravljen za živilske matrice, a se lahko uporablja tudi za druge matrice, npr. za žita in krmo. Zasnovan je bil kot sestavni del analitskih metod na osnovi nukleinske kisline, zlasti v okviru standarda ISO 21569 o kvalitativnih analitskih metodah in standarda ISO 21570 o kvantitativnih analitskih metodah.

General Information

Status
Published
Publication Date
14-Feb-2005
Withdrawal Date
30-Aug-2005
Current Stage
9093 - Decision to confirm - Review Enquiry
Start Date
08-Jan-2009
Completion Date
08-Jan-2009

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Živila - Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov - Izolacija nukleinskih kislin (ISO 21571:2005Lebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Nukleinsäureextraktion (ISO 21571:2005)Produits alimentaires - Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés - Extraction des acides nucléiques (ISO 21571:2005)Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Nucleic acid extraction (ISO 21571:2005)67.050Splošne preskusne in analizne metode za živilske proizvodeGeneral methods of tests and analysis for food productsICS:Ta slovenski standard je istoveten z:EN ISO 21571:2005SIST EN ISO 21571:2005en01-junij-2005SIST EN ISO 21571:2005SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 21571February 2005ICS 67.050English versionFoodstuffs - Methods of analysis for the detection of geneticallymodified organisms and derived products - Nucleic acidextraction (ISO 21571:2005)Produits alimentaires - Méthodes d'analyse pour ladétection des organismes génétiquement modifiés et desproduits dérivés - Extraction des acides nucléiques (ISO21571:2005)Lebensmittel - Verfahren zum Nachweis von gentechnischmodifizierten Organismen und irhen Produkten -Nukleinsäureextraktion (ISO 21571:2005)This European Standard was approved by CEN on 14 February 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.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, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21571:2005: ESIST EN ISO 21571:2005

Foreword
This document (EN ISO 21571:2005) 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 August 2005, and conflicting national standards shall be withdrawn at the latest by August 2005.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Reference numberISO 21571:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO21571First edition2005-02-15Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Nucleic acid extraction Produits alimentaires — Méthodes d'analyse pour la détection des organismes génétiquement modifiés et des produits dérivés — Extraction des acides nucléiques
ISO 21571:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2005 – All rights reserved
ISO 21571:2005(E) © ISO 2005 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Principle.1 3.1 General.1 3.2 DNA extraction.2 3.3 DNA quantitation.2 4 General laboratory requirements.2 5 Procedure.2 5.1 Preparation of the test portion.2 5.2 DNA extraction/purification.4 5.3 Quantitation of the extracted DNA.5 5.4 Stability of extracted DNA.6 6 Interpretation.6 7 Test report.6 Annex A (informative)
Methods for DNA extraction.7 Annex B (informative)
Methods for the quantitation of the extracted DNA.34 Bibliography.41
ISO 21571:2005(E) iv © ISO 2005 – All rights reserved 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 21571 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, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). SIST EN ISO 21571:2005

ISO 21571:2005(E) © ISO 2005 – All rights reserved v Introduction The search for genetically modified origin of ingredients is performed by means of the following successive (or simultaneous) steps. After sample collection, nucleic acids are extracted from the test portion. Extracted nucleic acids can be further purified, simultaneously or after the extraction process. Afterwards, they are quantified (if necessary), diluted (if necessary) and subjected to analytical procedures (such as PCR). These steps are detailed in this and the following International Standards: ISO 21568, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Sampling. ISO 21569, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Qualitative nucleic acid based methods. ISO 21570, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods. Further information about definitions and general items involving the steps cited above are collected in: ISO 24276, Foodstuffs — Nucleic acid based methods of analysis for the detection of genetically modified organisms and derived products — General requirements and definitions. 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 a patent concerning the silica-based extraction method (No. EP 0389063/USP 5,234,809) given in Clause A.4. ISO takes no position concerning the evidence, validity and scope of this patent right. The holder of this patent right has assured the ISO that he/she is willing to negotiate licences under reasonable and non-discriminatory terms and conditions with applicants throughout the world. In this respect, the statement of the holder of this patent right is registered with ISO. Information may be obtained from: Jean Deleforge, BioMérieux Chemin de l'Orme,
69280 Marcy-l'Étoile, France. 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.
INTERNATIONAL STANDARD ISO 21571:2005(E) © ISO 2005 – All rights reserved 1 Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Nucleic acid extraction 1 Scope This International Standard provides general requirements and specific methods for DNA extraction/purification and quantitation. These methods are described in Annexes A and B. This International Standard has been established for food matrices, but could also be applicable to other matrices, such as grains and feed. It has been designed as an integral part of nucleic-acid-based analytical methods, in particular ISO 21569 on qualitative analytical methods, and ISO 21570 on quantitative analytical methods. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 24276:—1), Foodstuffs — Nucleic acid based methods of analysis for the detection of genetically modified organisms and derived products — General requirements and definitions ISO 21568, Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Sampling 3 Principle 3.1 General The objective of nucleic acid extraction methods is to provide nucleic acids suitable for subsequent analysis (see ISO 24276). NOTE The “quality” of DNA depends on the average length of the extracted DNA molecules, the chemical purity and the structural integrity of the DNA sequence and of the double helix (e.g. intra-, inter-strand linking between DNA bases, single-strand gaps, cross-linking with polyols, haemin, etc). Moreover, such alterations are often sequence-specific and consequently not randomly distributed all over the genome (see References [1], [2], [3] and [4]). Users of this International Standard should note that some methods (e.g. all silica-based methods), might be covered by patent rights.
1) To be published. SIST EN ISO 21571:2005

ISO 21571:2005(E) 2 © ISO 2005 – All rights reserved 3.2 DNA extraction The basic principle of DNA extraction consists of releasing the DNA present in the matrix and further, concurrently or subsequently, purifying the DNA from polymerase chain reaction (PCR) inhibitors. DNA extraction/purification methods are described in Annex A. Method-selection is an experience-based choice of the use
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