ISO-24276-2006.pdf
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1、 Reference number ISO 24276:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 24276 First edition 2006-02-01 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions Produits alimentaires Mthodes danalyse pour la dtection
2、des organismes gntiquement modifis et des produits drivs Exigences gnrales et dfinitions Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking
3、 permitted without license from IHS -,-,- ISO 24276:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes 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
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6、m the Central Secretariat at the address given below. ISO 2006 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 ei
7、ther ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright Internatio
8、nal Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 24276:2006(E) ISO 2006 All rights reserved iii Contents Page Fo
9、reword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 3.1 General definitions . 1 3.2 Terms relative to extraction and purification of DNA . 5 3.3 Terms referring to DNA amplification and PCR. 5 3.4 Definitions referring to DNA and PCR controls. 5 3.5 Terms relati
10、ve to reference materials. 7 3.6 Terms relative to quantitation . 7 3.7 Terms relative to GMOs . 7 4 Application to the relevant International Standards. 7 4.1 General. 7 4.2 Guidance for the user on the selection of methods 8 4.3 Performance characteristics . 9 5 General laboratory and procedural r
11、equirements. 10 5.1 General. 10 5.2 Use of controls 10 5.3 Laboratory organization. 12 6 Interpretation and expression of results 13 6.1 General. 13 6.2 Interpretation of controls. 13 6.3 Expression of a negative result. 14 6.4 Expression of a positive result 14 6.5 Expression of ambiguous results.
12、14 6.6 Quality assurance requirements. 15 7 Test report . 15 Bibliography. 16 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted
13、without license from IHS -,-,- ISO 24276:2006(E) iv ISO 2006 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
14、 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 collaborate
15、s 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
16、. 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. Attention is drawn to the possibility that some of the elements of this
17、 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 24276 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food analysis Horizontal methods, in collaboration with Technical
18、 Committee ISO/TC 34, Food products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/
19、2007 21:40:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 24276:2006(E) ISO 2006 All rights reserved v Introduction The purpose of such an analysis is to identify and quantify genetic elements or proteins common to genetically modified organisms (GMOs) and their der
20、ived products in a given matrix. The main focus of this International Standard is polymerase chain reaction (PCR) based methodologies. However, because of the rapid rate of technological change in this area, other technologies may be considered in the future. The search for ingredients of geneticall
21、y modified origin is performed by means of the following successive (or simultaneous) steps. After sample collection, nucleic acids or proteins are extracted from the test portion. Extracted analytes can be further purified, simultaneously or after the extraction process. Afterwards, they are quanti
22、fied (if necessary), diluted (if necessary) and subjected to analytical procedures, such as PCR or Enzyme-Linked Immunosorbent Assay (ELISA). These steps are detailed in this International Standard and in the following documents: EN/TS 21568, Foodstuffs Methods of analysis for the detection of genet
23、ically modified organisms and derived products Sampling strategies 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 modi
24、fied organisms and derived products Quantitative nucleic acid based methods ISO 21571, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Nucleic acid extraction ISO 21572, Foodstuffs Methods for the detection of genetically modified organisms and
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