DIN EN ISO 24276-2013 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requirements and definitions (ISO 24276 20.pdf

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1、October 2013 Translation by DIN-Sprachendienst.English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 67.050!%)jD“2067133www.din.deDDIN EN ISO 24276Foodstuffs Methods of analysis for the detection of genetically modified organismsand derived products General requirements and definitions (ISO 24276:2006 + Amd 1:2013);English version EN ISO 24276:2006 + A1:2013,English translation of DIN EN ISO 2427

3、6:2013-10Lebensmittel Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihrenProdukten Allgemeine Anforderungen und Definitionen (ISO 24276:2006 + Amd 1:2013);Englische Fassung EN ISO 24276:2006 + A1:2013,Englische bersetzung von DIN EN ISO 24276:2013-10Produits alimentaires Mthod

4、es danalyse pour la dtection des organismes gntiquement modifis et desproduits drivs Exigences gnrales et dfinitions (ISO 24276:2006 + Amd 1:2013);Version anglaise EN ISO 24276:2006 + A1:2013,Traduction anglaise de DIN EN ISO 24276:2013-10SupersedesDIN EN ISO 24276:2006-05www.beuth.deIn case of doub

5、t, the German-language original shall be considered authoritative.Document comprises 25 pages10.13 DIN EN ISO 24276:2013-10 2 National foreword This document (EN ISO 24276:2006 + A1:2013) has been prepared by Technical Committee ISO/TC 34 “Food products”, Subcommittee SC 16 “Horizontal methods for m

6、olecular biomarker analysis” in collaboration with Technical Committee CEN/TC 275 “Food analysis Horizontal methods” (Secretariat: DIN, Germany), Working Group WG 11 “Genetically modified foodstuffs”, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). T

7、he responsible German body involved in its preparation was the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-01-04 AA Gentechnisch modifizierte Lebensmittel. This standard includes Amendment A1 approved by

8、 CEN on 2013-04-11. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“.The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5725-1 DIN ISO 5725-1 Amendments This standard differs from DIN EN I

9、SO 24276:2006-05 as follows: a) references to CEN/TS 21568 in the Introduction and in Figure 1 have been deleted; b) Subclause 3.1 “General definitions” has been updated; c) Figure 1 in Subclause 4.1 has been completed; d) Subclauses 4.3.2 “Limit of detection (LOD)“ and 4.3.3 “Limit of quantificatio

10、n (LOQ)” have been completely revised; e) Subclauses 5.1 “General” and 5.2 “Use of controls” have been revised with regard to the environmental control in Table 1 and its footnote b; f) Subclause 5.3.4 “Apparatus and equipment” has been updated and reference is now made to ISO/IEC 17025; g) Subclaus

11、e 6.3 “Expression of a negative result” has been modified; h) Subclause 6.4 “Expression of a positive result” has been modified; i) Subclause 6.5 “Expression of ambiguous results” has been modified; j) Clause 7 “Test report” has been modified with regard to the information to be contained; k) the Bi

12、bliography has been updated (see references 1, 5 and 6). Previous editions DIN EN ISO 24276: 2006-05 DIN EN ISO 24276:2013-10 3 National Annex NA (informative) Bibliography DIN ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions

13、 DIN EN ISO 24276:2013-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24276 February 2006 + A1 May 2013 ICS 67.050 English Version Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - General requi

14、rements and definitions (ISO 24276:2006 + Amd 1:2013) Produits alimentaires - Mthodes danalyse pour la dtection des organismes gntiquement modifis et des produits drivs - Exigences gnrales et dfinitions (ISO 24276:2006 + Amd 1:2013) EN ISO 24276:2006 was approved by CEN on 2006-01-23 and Amendment A

15、1:2013 on 2013-04-11. 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 standard

16、s 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 notif

17、ied 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, Ice

18、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centr

19、e: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24276:2006 + A1:2013 ELebensmittel - Verfahren zum Nachweis von gentechnisch modifizierten Organismen und ihren Produkten - Allgemeine An

20、forderungen und Definitionen (ISO 24276:2006 + Amd 1:2013) 2 Contents Page Foreword to EN ISO 24276:2006 3 !Foreword to EN ISO 24276:2006/A1:2013 .3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 3.1 General definitions 5 3.2 Terms relative to extraction and purificati

21、on of DNA 9 3.3 Terms referring to DNA amplification and PCR 9 3.4 Definitions referring to DNA and PCR controls 10 3.5 Terms relative to reference materials 11 3.6 Terms relative to quantitation 11 3.7 Terms relative to GMOs 11 4 Application to the relevant International Standards 12 4.1 General 12

22、 4.2 Guidance for the user on the selection of methods .13 4.3 Performance characteristics 14 5 General laboratory and procedural requirements 15 5.1 General 15 5.2 Use of controls .15 5.3 Laboratory organization 16 6 Interpretation and expression of results .18 6.1 General 18 6.2 Interpretation of

23、controls 18 6.3 Expression of a negative result 19 6.4 Expression of a positive result .19 6.5 Expression of ambiguous results 19 6.6 Quality assurance requirements 20 7 Test report 20 Bibliography 21 EN ISO 24276:2006 + A1:2013 (E) DIN EN ISO 24276:2013-10 A comma is used as the decimal marker. 3Fo

24、reword to EN ISO 24276:2006 This document (EN ISO 24276:2006) 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 shal

25、l be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2006, and conflicting national standards shall be withdrawn at the latest by August 2006. According to the CEN/CENELEC Internal Regulations, the national standards orga

26、nizations 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, Sl

27、ovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 24276:2006 has been approved by CEN as EN ISO 24276:2006 without any modification. ! Foreword to EN ISO 24276:2006/A1:2013 This document (EN ISO 24276:2006/A1:2013) has been prepared by Technical Comm

28、ittee 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 24276:2006 shall be given the status of a national standard, either by publication of an ide

29、ntical text or by endorsement, at the latest by November 2013, and conflicting national standards shall be withdrawn at the latest by November 2013. 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 h

30、eld 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 European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Eston

31、ia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The t

32、ext of ISO 24276:2006/Amd 1:2013 has been approved by CEN as EN ISO 24276:2006/A1:2013 without any modification.“ EN ISO 24276:2006 + A1:2013 (E) DIN EN ISO 24276:2013-10 4 Introduction onal Standard and in the following documents: ISO 21569, Foodstuffs Methods of analysis for the detection of genet

33、ically 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 ISO 21571, Foodstuffs Methods of analysis for the detection

34、 of genetically modified organisms and derived products Nucleic acid extraction ISO 21572, Foodstuffs Methods for the detection of genetically modified organisms and derived products Protein based methods Specific information pertaining to protein detection methods is found in ISO 21572.“ EN ISO 242

35、76:2006 + A1:2013 (E) DIN EN ISO 24276:2013-10 !The purpose of an analysis for the detection of genetically modified organisms and derived products is to identify and optionally quantify genetic elements or proteins common to genetically modified organisms (GMOs) and their derived products in a give

36、n matrix. These steps are detailed in this Internati51 Scope !This International Standard specifies how to use the standards for nucleic acid extraction (ISO 21571), qualitative nucleic acid analysis (ISO 21569), quantitative nucleic acid analysis (ISO 21570) and protein-based methods (ISO 21572), a

37、nd explains their relationship in the analysis of genetically modified organisms in foodstuffs.“ It contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods and test reports. It has been established for food matrices, but

38、 could also be applied to other matrices (e.g. seeds, feed and plant samples from the environment). 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 late

39、st edition of the referenced document (including any amendments) applies. ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 5725-

40、1 concerning validation, those in Reference 1 and the following apply. 3.1 General definitions 3.1.1 target taxon taxon to which the genetically modified organism belongs NOTE In this context, taxon usually means species but it could be of lower or higher taxonomic rank. ! 3.1.2 laboratory sample sa

41、mple received by the laboratory and intended for inspection or testing NOTE Adapted from ISO 7002:1986,9A.19. 3.1.3 test sample representative fraction of the laboratory sample to be ground 3.1.4 test portion portion of the test sample as prepared for testing or analysis, the whole quantity being us

42、ed for analyte extraction at one time NOTE Adapted from ISO 6887-2:2003,53.2. EN ISO 24276:2006 + A1:2013 (E) DIN EN ISO 24276:2013-10 6 3.1.5 specificity property of a method to respond exclusively to the characteristic or analyte under investigation 3.1.6 sensitivity change in the response divided

43、 by the corresponding change in the concentration of a standard (calibration) curve NOTE This is the slope of the analytical calibration curve. 3.1.7 limit of detection LOD minimum amount or concentration of the analyte in a test sample which can be detected reliably but not necessarily quantified,

44、as demonstrated by a collaborative trial or other appropriate validation NOTE See Reference 2 for collaborative trial and Reference 3 for validation. 3.1.8 limit of quantification LOQ lowest concentration or amount of the analyte in a test sample which can be quantitatively determined with an accept

45、able level of precision and accuracy, as demonstrated by a collaborative trial or other appropriate validation NOTE See Reference 2 for collaborative trial and Reference 3 for validation. 3.1.9 accuracy closeness of agreement between a test result and the accepted reference value ISO 5725-1:1994, 3.

46、6 3.1.10 trueness closeness of agreement between the average value obtained from a large series of test results and an accepted reference value NOTE 1 The measure of trueness is usually expressed in terms of bias. Trueness has been referred to as “accuracy of the mean”. NOTE 2 Adapted from ISO 5725-

47、1:1994, 3.7. 3.1.11 precision closeness of agreement between independent test results obtained under stipulated conditions NOTE 1 Precision depends only on the distribution of random errors and does not relate to the true value or to the specified value. NOTE 2 The measure of precision usually is ex

48、pressed in terms of imprecision and computed as a standard deviation of the test results. Lower precision is reflected by a larger standard deviation. NOTE 3 “Independent test results” means results obtained in a manner not influenced by any previous result on the same or similar test object. Quanti

49、tative measures of precision depend critically on the stipulated conditions. Repeatability and reproducibility conditions are particular sets of extreme conditions. ISO 5725-1:1994, 3.12 EN ISO 24276:2006 + A1:2013 (E) DIN EN ISO 24276:2013-10 EN ISO 24276:2006 + A1:2013 (E) 73.1.12 repeatability precision under repeatability conditions ISO 5725-1:1994, 3.13 3.1.13 reproducibility precision under reproducibility condit