EN ISO 21571-2005 en Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Nucleic acid extraction (Incorporates Amendment A1 .pdf

1、BRITISH STANDARD BS ENISO 21571:2005Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Nucleic acid extractionICS 67.050nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nullnullnull nullnullnullnullnullnullnullnullnullnull nullnu

2、llnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnull+A1:2013National forewordThis British Standard is the UK implementation of EN ISO 21571:2005+A1:2013. It is identical to ISO 21571:2005, incorporating amendment 1:2013. It super

3、sedes BS EN ISO 21571:2005, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by !“.The UK participa

4、tion in its preparation was entrusted to Technical Committee AW/275, Food analysis Horizontal methods.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are r

5、esponsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 21571:2005+A1:2013This British Standard waspublished under the authorityof the Standards Policy andStrategy Committee on24 March 2005 The British Standards Institution 20

6、13. Published by BSI Standards Limited 2013.Amendments/corrigenda issued since publicationDate Comments 31 May 2013 Implementation of ISO amendment 1:2013 with CEN endorsement A1:2013ISBN 978 0 580 75322 0EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21571:2005+A1March 2013ICS 67.050English

7、versionFoodstuffs - Methods of analysis for the detection of geneticallymodified organisms and derived products - Nucleic acidextraction (ISO 21571:2005)Produits alimentaires - Mthodes danalyse pour ladtection des organismes gntiquement modifis et desproduits drivs - Extraction des acides nucliques

8、ISO21571:2005)Lebensmittel - Verfahren zum Nachweis von gentechnischmodifizierten Organismen und irhen Produkten -Nukleinsureextraktion (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 stip

9、ulate 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 exis

10、ts 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

11、 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 STAN

12、DARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21571:2005: E2 Foreword This document (EN ISO 2157

13、1:2005) has been prepared by TechnicalCommittee CEN/TC 275 “Foodanalysis- 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

14、publication of an identicaltext or by endorsement, at the latest by August 2005, and conflicting national standards shallbewithdrawn at the latest by August2005.Accordingto theCEN/CENELEC Internal Regulations,the national standardsorganizationsofthe following countries are bound to implement this Eu

15、ropean 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, Switzerlandand United Kingdom.Foreword to amendmen

16、t A1 This document (EN ISO 21571:2005/A1:2013) has been prepared by Technical Committee ISO/TC 34 “Food products“ in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 21571:20

17、05 shall be given the status of a na tional standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Attention is drawn to the possibility that some of the elements

18、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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europea

19、n Standard: 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, Slovakia, Sloven

20、ia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21571:2005/Amd 1:2013 has been approved by CEN as EN ISO 21571:2005/A1:2013 without any modification. BS EN ISO 21571:2005+A1:2013 ISO 21571:2005+A1:2013 (E)EN Reference numbe rISO 21571:2005(E) OSI 500

21、2INTERNATIONAL STANDARDISO21571First edition2005-02-15Foodstuffs Methods of analysis for the detection of geneticallymodifiedorganisms and derived products Nucleic acid extraction Produits alimentaires Mthodes danalyse pour la dtection desorganismes gntiquement modifis et des produits drivs Extracti

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27、02(E)I SO 5002 All irthgs ersedevr iiiContents PageForewordivIntroduction v1Scope12Normative references .13Principle.13.1 General.13.2 DNA extraction23.3 DNA quantitation.24General laboratoryrequirements25Procedure.25.1 Preparation of the test portion.25.2 DNA extraction/purification45.3 Quantitatio

28、n of the extracted DNA55.4 Stability of extracted DNA66Interpretation.67Test report6Annex A (informative) Methods for DNAextraction7Annex B (informative) Methods for the quantitation of the extracted DNA 34Bibliography.BS EN ISO 21571:2005+A1:2013 ISO 21571:2005+A1:2013 (E)5 0iv I SO 5002 All irthgs

29、 ersedevrForeword 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

30、which a tec hnical committee has beenestablished 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 closelywith the International Electrotechnical Commission (IEC) on all

31、 matters of electrotechnical standardization. International Standards are drafted in accordancewith the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circ

32、ulated to the member bodies for voting. Publication as an International Standard requires approval byat least 75 % of the member bodies casting a vote. ISO21571 was prepared by the European Comm ittee for Standardization (CEN) Technical Committee CEN/TC 275, Food analysis Horizontal methods, in coll

33、aboration with Technical Committee ISO/TC34, Food products, in accordance with the Agreement on technical cooperation between ISO and CEN ( ViennaAgreement).BS EN ISO 21571:2005+A1:2013ISO 21571:2005+A1:2013 (E)vIntroduction The search for geneticallymodified origin of ingredients is performed by me

34、ans of the following successive (orsimultaneous) 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, theyare quantified (if necessary), diluted (if necessary)an

35、d subjected to analytical procedures (such asPCR). Thesesteps are detailed in this and the following International Standards: ISO 21569, Foodstuffs Methods of analysisfor the detection of genetically modified organisms and derived products Qualitative nucleic acid based methods.ISO 21570, Foodstuffs

36、 Methods of analysisfor 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 Methods of analysis for the detection o

37、f 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 compliancewith this document may involve the use of a patent concerning the silica-based extraction

38、method(No. EP 0389063/USP 5,234,809) given in Clause A.4.ISO takes no position concerning the evidence, validityand scope of this patent right. The holder of this patent right has assured the ISO that he/she is willing to negotiate licences underreasonable and non-discriminatory terms and conditions

39、 with applicants throughout the world. In this respect,the statement of the holder of this patent right is registered with ISO. Information maybe obtained from: Jean Deleforge, BioMrieuxChemin de lOrme, 69280 Marcy-ltoile, France. Attention is drawn to the possibility that some of the elements of th

40、is document may be the subject of patent rights other than those identified above. ISO shall not be held responsible for identifying anyor all suchpatentrights.!Text deleted“!“BS EN ISO 21571:2005+A1:2013 ISO 21571:2005+A1:2013 (E)blank Foodstuffs Methods of analysis for the detection of genetically

41、 modified organisms and derivedproducts 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 fo

42、r food matrices, but could also be applicable to othermatrices, such as grains and feed. It has been designed as an integral part of nucleic-acid-based analytical methods, in particular ISO 21569 onqualitative analytical methods, and ISO 21570 on quantitative analytical methods. 2 Normativereference

43、sThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including anyamendments) applies.ISO 24276:2006, Foodstuffs Methods of analysis for t

44、he detection of genetically modified organisms andderived products G eneral requirements and definitions3 Principle 3.1 General The objectiveof nucleic acid extraction methods isto provide nucleic acids suitable for subsequent analysis (see ISO 24276). NOTE The “quality” of DNA depends on the averag

45、e length of the extracted DNA molecules, the chemical purity andthe 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-specif

46、ic andconsequently 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. !Note deleted“!Text deleted“!“.BS EN ISO 21571:2005+A1:2013 ISO 21571

47、2005+A1:2013 (E)1 IS:17512 O5002(E)I SO 5002 All irthgs ersedevr3.2 DNAextraction 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/pu

48、rification methods ar e described inAnnexA. Me thod-selection is anexperience-basedchoice of the user, taking into account the scope and examples of matrices as given in each method. Alternative protocols are suitable provided that the method has been validated on the r espective matrix underinvesti

49、gation. 3.3 DNAquantitation Quantitation of extracted DNA could be useful for subsequent PCR analysis. It may be performed by either physical (e.g. measure of absorbance at a specific wavelength), chemical-physical (e.g. use of intercalating or binding agents able to emit fluorescence), enzymatic(e.g. bioluminescence detection) methods or by q