ISO-22174-2005.pdf
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1、 Reference number ISO 22174:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 22174 First edition 2005-02-15 Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions Microbiologie des aliments Raction de p
2、olymrisation en chane (PCR) pour la recherche de micro-organismes pathognes dans les aliments 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, 04/20/2007 03:3
3、2:12 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22174:2005(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
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6、relating to it is found, please inform the Central Secretariat at the address given below. 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,
7、without permission in writing from either 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 2005 All
8、 rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:32:12 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22174:2005(E) ISO 2005 All
9、 rights reserved iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Principle.6 4.1 General.6 4.2 Preliminary microbial enrichment.6 4.3 Nucleic acid preparation 6 4.4 PCR amplification .6 4.5 Detection and confirmation of PCR products7 5 Test
10、material7 6 General laboratory requirements 7 6.1 General.7 6.2 Personnel.7 6.3 Laboratory setup.7 6.4 Waste management 8 7 Reagents8 8 Apparatus and equipment8 8.1 General.8 8.2 Special considerations.8 9 Procedure.8 9.1 Sample preparation.8 9.2 Amplification .9 9.3 Control reaction 9 9.4 Confirmat
11、ion of PCR results9 10 Evaluation10 11 Test report10 Bibliography .11 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:32:12 MDTNo reproduction or networking permitted without
12、license from IHS -,-,- ISO 22174:2005(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 tec
13、hnical 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 closel
14、y 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
15、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 22174 was prepared by the European Committee for Standardization (CEN) Tech
16、nical 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). Copyright International Organization fo
17、r Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:32:12 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22174:2005(E) ISO 2005 All rights reserved v Introduction The polymerase chain rea
18、ction (PCR) is a fast, sensitive and specific method for the detection of food-borne pathogens. Although a relatively young technology, the application of PCR-based methods in food analysis is increasing. In brief, existing protocols can be divided in two main groups, depending on the type of nuclei
19、c acid used as target for amplification: RNA-based amplification (RT-PCR); DNA-based amplification (PCR). Numerous variations of both methods have been established and can be characterized by their degree of complexity and automation. The level of specificity of the methods varies from screening ass
20、ays which detect nucleic acid sequences common to a microbiological genus, to specific assays which identify nucleic acid sequences unique to an individual strain- or type-specific nucleic acid sequence. This International Standard presents a comprehensive list of requirements for PCR-based methods
21、used for the detection of microorganisms in food samples. It contains terms and definitions used in reference to PCR and RT-PCR. ISO 22174 is part of a series of International Standards and a Technical Specification under the general title Microbiology of food and animal feeding stuffs Polymerase ch
22、ain reaction (PCR) for the detection of food- borne pathogens: General requirements and definitions (ISO 22174); Requirements for sample preparation for qualitative detection (ISO 20837) 1); Requirements for amplification and detection for qualitative methods (ISO 20838) 1); Performance testing for
23、thermal cyclers (ISO/TS 20836) 1). 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, valid
24、ity 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 the ISO that they are willing to negotiate licences under reasonable and non-di
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