DIN EN ISO 6579-1-2017 Microbiology of the food chain - Horizontal method for the detection enumeration and serotyping of Salmonella - Part 1 Detection of Salmonella spp (ISO 6579-.pdf

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1、July 2017 English price group 23No 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).ICS 07.100.30!%gg(“2686805www.din.deDIN

2、 EN ISO 6579-1Microbiology of the food chain Horizontal method for the detection, enumeration and serotyping of Salmonella Part 1: Detection of Salmonella spp. (ISO 65791:2017);English version EN ISO 65791:2017,English translation of DIN EN ISO 6579-1:2017-07Mikrobiologie der Lebensmittelkette Horiz

3、ontales Verfahren zum Nachweis, zur Zhlung und zur Serotypisierung von Salmonellen Teil 1: Nachweis von Salmonella spp. (ISO 65791:2017);Englische Fassung EN ISO 65791:2017,Englische bersetzung von DIN EN ISO 6579-1:2017-07Microbiologie de la chane alimentaire Mthode horizontale pour la recherche, l

4、e dnombrement et le srotypage des Salmonella Partie 1: Recherche des Salmonella spp. (ISO 65791:2017);Version anglaise EN ISO 65791:2017,Traduction anglaise de DIN EN ISO 6579-1:2017-07SupersedesDIN EN ISO 6579:200710 andDIN EN ISO 6785:200709www.beuth.deDocument comprises 60 pagesDTranslation by DI

5、N-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.06.17 DIN EN ISO 6579-1:2017-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 6579-1:2017) has been prepared by Technical Committee ISO/TC 34 “Food products” (Secretar

6、iat: AFNOR, France) in collaboration with Technical Committee CEN/TC 275 “Food analysis Horizontal methods” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agr

7、icultural Products), Working Committee NA 057-01-06 AA “Microbiology of the food chain”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 707 DIN EN ISO 707 ISO 6579:2002 DIN EN ISO 6579:2002-12 ISO 6579:2002/Amd 1:2007 DIN EN ISO 6579:2

8、007-10 ISO 6785:2001 DIN EN ISO 6785:2007-09 ISO 6887 (all parts) DIN EN ISO 6887 (all parts) ISO 6887-1:2017 DIN EN ISO 6887-1:2017-xx*)ISO 7218 DIN EN ISO 7218 ISO 11133:2014 DIN EN ISO 11133:2015-01 ISO 16140:2003 DIN EN ISO 16140:2003-09 ISO 16140-1 DIN EN ISO 16140-1 ISO 16140-2 DIN EN ISO 1614

9、0-2 ISO 17468 DIN EN ISO 17468 ISO 18593 DIN ISO 18593 ISO 13307 DIN EN ISO 13307 ISO 17604 DIN EN ISO 17604 ISO/TR 6579-3 DIN CEN ISO/TR 6579-3 ISO/TS 6579-2 DIN CEN ISO/TS 6579-2, DIN SPEC 10052 ISO/TS 17728 DIN CEN ISO/TS 17728; DIN SPEC 10053 *)Not yet published; publication planned for 2017. DI

10、N EN ISO 6579-1:2017-07 3 Amendments This standard differs from DIN EN ISO 6579:2007-10 and DIN EN ISO 6785:2007-09 as follows: a) DIN EN ISO 6785:2007-09 Milk and milk products Detection of Salmonella spp. (ISO 6785:2001) has been integrated in this standard DIN EN ISO 6579-1; b) the Scope includes

11、 samples from the primary reduction stage; c) in the Normative Annex, the detection of Salmonella Typhi und Salmonella Paratyphi is described; d) for selective enrichment, there is a choice between using the broth or the semi-solid agar of Rappaport Vassilidis medium (RVS or MSRV); e) the inoculatio

12、n of the isolation medium has become less prescriptive. The objective is to obtain well-isolated colonies after incubation; f) for confirmation, it is acceptable to perform the tests on only one suspect colony (instead of one suspect colony of each medium combination). If this isolate tests negative

13、 for Salmonella, four more suspect isolates from different media combinations shall be tested; g) it is permitted to perform the biochemical confirmation directly on a suspect, well-isolated colony from the selective plating medium. The purity check on the non-selective agar medium can then be perfo

14、rmed in parallel; h) two confirmation tests have become optional (-galactosidase test and indole reaction) and one confirmation test has been deleted (Voges-Proskauer reaction); i) in this document, serological confirmation (to serogroup level) is described. For guidance on serotyping (to serovar le

15、vel), reference is made to ISO/TR 6579-3. j) Table 1 (Interpretation of biochemical tests) has been improved; k) performance testing for the quality assurance of the culture media has been added to Annex B; l) performance characteristics of MSRV have been added to Annex C; m) the document has been e

16、ditorially revised. Previous editions DIN EN 12824: 1998-02 DIN EN ISO 6579: 2002-12, 2003-03, 2007-10 DIN EN ISO 6785: 2007-09 DIN EN ISO 6579-1:2017-07 4 National Annex NA (informative) Bibliography DIN CEN ISO/TS 6579-2 (DIN SPEC 10052-2), Microbiology of food and animal feed Horizontal method fo

17、r the detection, enumeration and serotyping of Salmonella Part 2: Enumeration by a miniaturized most probable number technique DIN CEN ISO/TR 6579-3, Microbiology of food and animal feed Horizontal method for the detection, enumeration and serotyping of Salmonella Part 3: Guidelines for serotyping o

18、f Salmonella spp. DIN CEN ISO/TS 17728 (DIN SPEC 10053), Microbiology of the food chain Sampling techniques for microbiological analysis of food and feed samples DIN EN ISO 707, Milk and milk products Guidance on sampling DIN EN ISO 6579:2002-12, Microbiology of food and animal feeding stuffs Horizo

19、ntal method for the detection of Salmonella spp. (ISO 6579:2002) DIN EN ISO 6579:2007-10, Microbiology of food and animal feeding stuffs Horizontal method for the detection of Salmonella spp. (ISO 6579:2002+Amd 1:2007) DIN EN ISO 6785:2007-09, Milk and milk products Detection of Salmonella spp. (ISO

20、 6785:2001) DIN EN ISO 16140:2003-09, Microbiology of food and animal feeding stuffs Protocol for the validation of alternative methods (ISO 16140:2003) DIN EN ISO 16140-1, Microbiology of food and animal feed Method validation Part 1: Vocabulary DIN EN ISO 16140-2, Microbiology of food and animal f

21、eed Method validation Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method DIN EN ISO 6887 (all parts), Microbiology of food and animal feeding stuffs Preparation of the test samples, of initial suspension and of decimal dilutions for microbiological ex

22、amination DIN EN ISO 6887-1:2017-xx, Microbiology of food and animal feeding stuffs Preparation of the test samples, of initial suspension and of decimal dilutions for microbiological examination Part 1: General rules for the preparation of the initial suspension and decimal dilutions (ISO 6887-1:20

23、17) DIN EN ISO 7218, Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations DIN EN ISO 11133:2015-01, Microbiology of food, animal feed and water Preparation, production, storage and performance testing of culture media DIN EN ISO 13307, Mic

24、robiology of food and animal feed Primary production stage Sampling techniques DIN EN ISO 17468, Microbiology of the food chain Technical requirements and guidance on establishment or revision of a standardized reference method DIN EN ISO 17604, Microbiology of the food chain Carcass sampling for mi

25、crobiological analysis DIN ISO 18593, Microbiology of food and animal feeding stuffs Horizontal methods for sampling techniques from surfaces using contact plates and swabs EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6579-1 March 2017 ICS 07.100.30 Supersedes EN ISO 6579:2002, EN ISO 67

26、85:2007English Version Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella -Part 1: Detection of Salmonella spp. (ISO 6579-1:2017) Microbiologie de la chane alimentaire - Mthode horizontale pour la recherche, le dnombrement et le srotypage d

27、es Salmonella - Partie 1: Recherche des Salmonella spp. (ISO 6579-1:2017) Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zum Nachweis, zur Zhlung und zur Serotypisierung von Salmonellen - Teil 1: Nachweis von Salmonella spp. (ISO 6579-1:2017) This European Standard was approved by CEN

28、on 3 February 2017. 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 standards

29、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 notifie

30、d 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, Icela

31、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELE

32、C Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6579-1:2017 EEuropean foreword .4Introduction .71 Scope 82 Normative references . 83 Terms and definitions 84 Principle

33、 . 94.1 General 94.2 Pre-enrichment in non-selective liquid medium 94.3 Enrichment in/on selective media 94.4 Plating out on selective solid media 94.5 Confirmation 105 Culture media, reagents, and antisera . 106 Equipment and consumables 107 Sampling 118 Preparation of test sample . 119 Procedure (

34、see diagrams in Annex A) 119.1 Test portion and initial suspension . 119.2 Non-selective pre-enrichment . 119.3 Selective enrichment 129.3.1 General 129.3.2 Procedure for food, animal feed samples, and environmental samples from the food production area . 129.3.3 Procedure for samples from the prima

35、ry production stage . 129.4 Plating out . 139.4.1 General 139.4.2 Procedure for food, animal feed samples, and environmental samples from the food production area . 139.4.3 Procedure for samples from the primary production stage . 139.5 Confirmation . 149.5.1 General 149.5.2 Selection of colonies fo

36、r confirmation 149.5.3 Biochemical testing . 159.5.4 Serological testing .189.5.5 Interpretation of biochemical and serological reactions .189.5.6 Serotyping 1910 Expression of results 1911 Performance characteristics of the method .1911.1 Interlaboratory studies 1911.2 Sensitivity 1911.3 Specificit

37、y 1911.4 LOD50.12 Test report .20Annex A (normative) Diagrams of the procedures 21Annex B (normative) Culture media and reagents 23Contents PageForeword .5DIN EN ISO 6579-1:2017-07 EN ISO 6579-1:2017 (E) 219Annex E (informative) Examples of selective plating-out media 49Bibliography .54Annex C (info

38、rmative) Method validation studies and performance characteristics .38Annex D (normative) Detection of Salmonella enterica subspecies enterica serovars Typhi and Paratyphi 44DIN EN ISO 6579-1:2017-07 EN ISO 6579-1:2017 (E) 3 European foreword This document (EN ISO 6579-1:2017) has been prepared by T

39、echnical Committee CEN/TC 275 “Food analysis - Horizontal methods”, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 34 “Food products“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by

40、endorsement, at the latest by September 2017 and conflicting national standards shall be withdrawn at the latest by September 2017. 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 held responsible f

41、or identifying any or all such patent rights. This document supersedes EN ISO 6579:2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According to the CEN-CENELEC Internal Regulations, the national standards organiza

42、tions of the following countries are bound to implement this European 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, Mal

43、ta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 6579-1:2017 has been approved by CEN as EN ISO 6579-1:2017 without any modification. DIN EN ISO 6579-1:2017-07 EN ISO 6579-1:2

44、017 (E) 4 ForewordISO (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

45、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 closely with the International Electrotechnical Commission (IEC) on al

46、l matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. Th

47、is document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).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

48、 or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers

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