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1、a Date: 10 September 2007 Origin: International Latest date for receipt of comments: 31 December 2007 Project no.: 2007/02448 Responsible committee: AW/9 Microbiology Interested committees: Title: Draft BS ISO 22119: Microbiology of food and animal feeding stuffs - Real-time polymerase chain reactio
2、n (PCR) for the detection of food-borne pathogens - General requirements and definitions Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede. NONE If you are aware of a current national standard which may be a
3、ffected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 31 December 2007. This draft is issued to allow comments from interested parties; all comments will be given consideration p
4、rior to publication. No acknowledgement will normally be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organiz
5、ation for briefing purposes. Electronic circulation is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email ordersbsi-. British, International and foreign stand
6、ards are also available from BSI Customer Services. British Standards on CD or Online are available from British Standards Publishing Sales Limited. Tel: 01344 404409 or email bsonlinetechindex.co.uk. Information on the co-operating organizations represented on the committees referenced above may be
7、 obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http:/www.bsi-. Direct tel: 020 8996 7445 Responsible
8、Committee Secretary: K Seyde (BSI) E-mail: keith.seydebsi- Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 7.0 DPC: 07/30171460 DC Licensed Copy: London South Bank University, London South Bank University
9、, Fri Oct 05 02:17:33 GMT+00:00 2007, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are invited and will assist in the preparation of the consequent standard. Comments submitte
10、d will be reviewed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments received. If no comments are received to the contrary, then the UK will approve this draft. If
11、the international standard is approved, it is possible the text will be published as an identical British Standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intended to ensure th
12、at all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Comments
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14、he example below. Further information on submitting comments and how to obtain a blank electronic version of a comment form are available from the BSI web site at: http:/www.bsi- Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause
15、 No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to re
16、ad . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Windo
17、ws is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:33 GMT+00:00 2007, Uncontrolled Copy, (c) BSI THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRE
18、D TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH
19、 REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. DRAFT INTERNATIONAL STANDARD ISO/DIS 22119 International Organization for S
20、tandardization, 2007 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATION ISO/TC 34/SC 9 Voting begins on: 2007-09-06 Secretariat: AFNOR Voting terminates on: 2008-02-06 Microbiology of food and animal feeding stuffs Real-time polymerase chain reaction (PCR) fo
21、r the detection of food-borne pathogens General requirements and definitions Microbiologie des aliments Raction de polymrisation en chane (PCR) en temps rel pour la dtection des micro-organismes pathognes dans les aliments Exigences gnrales et dfinitions ICS 07.100.30 ISO/CEN PARALLEL ENQUIRY This d
22、raft International Standard is a draft standard developed within the European Committee for Standardization (CEN) and processed under the CEN-lead mode of collaboration as defined in the Vienna Agreement. The document has been transmitted by CEN to ISO for circulation for ISO member body voting in p
23、arallel with CEN enquiry. Comments received from ISO member bodies, including those from non-CEN members, will be considered by the appropriate CEN technical body. Should this DIS be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two- month FD
24、IS vote in ISO and formal vote in CEN. In accordance with the provisions of Council Resolution 15/1993 this document is circulated in the English language only. Conformment aux dispositions de la Rsolution du Conseil 15/1993, ce document est distribu en version anglaise seulement. To expedite distri
25、bution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at publication stage. Pour acclrer la distribution, le prsent document est distribu tel quil est parvenu du secrtariat du comit. Le travail
26、de rdaction et de composition de texte sera effectu au Secrtariat central de lISO au stade de publication. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:33 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ISO/DIS 22119 ii ISO 2007 All rights reserved PDF discl
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32、 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:33 GMT+00:00 2007, Uncontr
33、olled Copy, (c) BSI ISO/DIS 22119 ISO 2007 All rights reserved iii Contents Page Foreword iv Introductioniv 1 Scope1 2 Normative references1 3 Terms and definitions.1 4 Principle .6 5 Test material 7 6 General laboratory requirements.7 7 Reagents 7 8 Apparatus and equipment8 9 Procedure.9 10 Evaluat
34、ion and documentation11 Bibliography12 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:33 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ISO/DIS 22119 iv ISO 2007 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldw
35、ide 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 th
36、at 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
37、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 r
38、equires 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22119 was prepared by Tech
39、nical Committee ISO/TC 34, Food products, Subcommittee SC 9, and by Technical Committee CEN/TC 275, Food analysis - Horizontal methods in collaboration. This second/third/. edition cancels and replaces the first/second/. edition (), clause(s) / subclause(s) / table(s) / figure(s) / annex(es) of whic
40、h has / have been technically revised. Introduction The polymerase chain reaction (PCR) has been shown to be a fast, sensitive and specific method for detection of food-borne pathogens. Further developments of the technology allow the detection of specific PCR products generated by the amplification
41、 process. The principle relies on the excitation of fluorescent markers during the PCR process. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:33 GMT+00:00 2007, Uncontrolled Copy, (c) BSI DRAFT INTERNATIONAL STANDARD ISO/DIS 22119 ISO 2007 All rights res
42、erved 1 1 Scope This standard is applicable to the detection of food-borne pathogens in foodstuffs, and isolates obtained from them, using the polymerase chain reaction (PCR). The standard describes requirements for the amplification and detection of nucleic acid sequences (DNA or RNA after reverse
43、transcription) by real-time PCR. The minimum requirements laid down in the standard provide the basis for comparable and reproducible results in individual and between different laboratories. NOTE The standard can also be used for other purposes in the foodstuffs sector (e.g. the detection of food-b
44、orne pathogens in environmental samples), and for animal feeding stuffs. NOTE Because of the rapid progress in this field, the examples given are those most frequently used at time when the standard was developed. 2 Normative references The following referenced documents are indispensable for the ap
45、plication 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 22174, Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of f
46、ood-borne pathogens General requirements and definitions ISO 20838, Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food borne pathogens Requirements for amplification and detection for qualitative methods 3 Terms and definitions For the purposes o
47、f this International Standard, the following terms and definitions apply. 3.1 real-time polymerase chain reaction (real-time PCR) enzymatic procedure which combines the in vitro amplification of specific DNA segments by a process of denaturation, annealing of specific primers, and synthesis of DNA w
48、ith the detection of specific PCR products during the amplification process NOTE Generally, the amplification reaction mixture contains one or more specific DNA probes coupled with one or more fluorescent dyes. Using this technology, the signal is generated after specific hybridisation of the probes
49、 to the target nucleic acid sequence and excitation with light of a definite wavelength. 3.2 PCR product DNA amplified by PCR ISO 22174 Microbiology of food and animal feeding stuffs Real-time polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions Licensed Copy: London South Bank University, London South Bank Univer