EN ISO 10273-2017 en Microbiology of the food chain - Horizontal method for the detection of pathogenic Yersinia enterocolitica《食品和动物饲料的微生物学 检验和计数弯曲菌的等同方法 》.pdf

1、Microbiology of the food chain Horizontal method for the detection of pathogenic Yersinia enterocoliticaBS EN ISO 10273:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 10273:2017. It is ide

2、ntical to ISO 10273:2017. It supersedes BS EN ISO 10273:2003 , which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee AW/9, Microbiology.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does no

3、t purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 83265 9ICS 07.100.30Compliance with a British Standard cannot confer immunity from legal ob

4、ligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 10273:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10273April 2017I

5、CS 07.100.30 Supersedes EN ISO 10273:2003EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 10273:2017: EAll rights of exploitation in any form and by any means re

6、served worldwide for CEN national MembersMicrobiology of the food chain - Horizontal method for the detection of pathogenic Yersinia enterocolitica (ISO 10273:2017)Microbiologie de la chane alimentaire - Mthode horizontale pour la recherche de Yersinia enterocolitica pathognes (ISO 10273:2017)Mikrob

7、iologie der Lebensmittelkette - Horizontales Verfahren zum Nachweis von pathogenen Yersinia enterocolitica (ISO 10273:2017)This European Standard was approved by CEN on 13 March 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving t

8、his European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official

9、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 notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austr

10、ia, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain

11、, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 10273:2017 (E)European forewordThis document (EN ISO 10273:2017) has been prepared by Technical Committee ISO/TC 34 “Food products“ in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the sec

12、retariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2017, and conflicting national standards shall be withdrawn at the latest by October 2017.Attention is draw

13、n 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 for identifying any or all such patent rights.This document supersedes EN ISO 10273:2003 .This document has been prepared under a mandate given to CEN

14、 by the European Commission and the European Free Trade Association.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,

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

16、noticeThe text of ISO 10273:2017 has been approved by CEN as EN ISO 10273:2017 without any modification.iiBS EN ISO 10273:2017ISO 10273:2017(E)Foreword vIntroduction vii1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviated terms 25 Principle 25.1 General . 25.2 Direct plating f

17、rom liquid enrichment medium . 25.3 Enrichment in liquid enrichment medium and selective liquid enrichment medium 25.4 Plating out after enrichment and identification . 25.5 Confirmation . 36 Culture media and reagents 37 Equipment and consumables 37.8 Peristaltic blender. . 38 Sampling 39 Preparati

18、on of test sample . 410 Procedure (as shown in Annex A) . 410.1 Test portion and initial suspension . 410.2 Direct plating on selective agar 410.3 Enrichment . 510.4 Plating out and incubation of plates . 510.4.1 Plating from PSB and ITC by KOH treatment on CIN agar 510.4.2 Plating from PSB and ITC

19、by KOH treatment on chromogenic agar (optional) . 510.5 Identification of characteristic colonies 510.6 Confirmation . 610.6.1 General 610.6.2 Selection of colonies for confirmation 610.6.3 Determination of pathogenic Yersinia species . 610.6.4 Confirmation of pathogenic Y. enterocolitica 810.6.5 In

20、terpretation of confirmation tests for Y. enterocolitica .1010.6.6 Interpretation of confirmation tests for pathogenic Y. enterocolitica 1010.7 Biotyping of Y. enterocolitica (optional) . 1010.7.1 General. 1010.7.2 Fermentation of xylose 1110.7.3 Tween-esterase test .1110.7.4 Fermentation of salicin

21、 (optional) and trehalose .1110.7.5 Indole formation .1110.7.6 Interpretation of biotyping tests . 1111 Expression of results .1212 Performance characteristics of the method 1212.1 Interlaboratory study . 1212.2 Sensitivity . 1212.3 Specificity . 1212.4 LOD501213 Test report 1314 Quality assurance .

22、13Annex A (normative) Diagrams of the procedures .14 ISO 2017 All rights reserved iiiContents PageBS EN ISO 10273:2017ISO 10273:2017(E)Annex B (normative) Composition and preparation of culture media and reagents .17Annex C (informative) Method validation studies and performance characteristics .32A

23、nnex D (informative) Procedure for cold enrichment .34Bibliography .39iv ISO 2017 All rights reservedBS EN ISO 10273:2017ISO 10273:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing

24、 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 that committee. International organizations, governmental and non-governmental, in liais

25、on with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Dire

26、ctives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This 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 so

27、me 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. 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 declar

28、ations 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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity as

29、sessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/

30、TC 275, Food analysis Horizontal methods, in collaboration with ISO 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).This third edition cancels and replaces the second editi

31、on (ISO 10273:2003 ), which has been technically revised with the following main changes. In confirmation of pathogenic Y. enterocolitica, tests related to pathogenicity have been added or specified and relocated in the frontline. Accordingly, the word “presumptive” has been removed from the title w

32、ording (pathogenic Y. enterocolitica) since standard contains mandatory tests related to pathogenicity and allows separation of pathogenic and non-pathogenic Y. enterocolitica. Direct plating on cefsulodin, IrgasanTM1)and novobiocin (CIN) agar has been added. Incubation time for peptone, sorbitol an

33、d bile salts (PSB) enrichment broth and CIN agar has been changed. Inoculation and incubation time for IrgasanTM, ticarcillin and potassium chlorate (ITC) enrichment broth has been changed and specified. Salmonella/shigella agar with sodium desoxycholate and calcium chloride (SSDC) has been replaced

34、 by CIN agar and optional chromogenic medium. Inoculation of CIN agar without prior potassium hydroxide (KOH) treatment of enrichment broth has been changed to optional procedure (in parallel to mandatory KOH treatment). The preparation (shelf life) of KOH and ammonium iron(II) sulfate solutions has

35、 been specified.1) IrgasanTMis an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product. ISO 2017 All rights reserved vBS EN ISO 10273:2017ISO 10273:2017(E) Suspect c

36、olonies from primary culture are streaked (purified) on CIN agar and (optionally) on chromogenic agar to facilitate better selection of characteristic colonies that need further confirmation. The use of stereomicroscope in identification of characteristic colonies is emphasized. All biochemical conf

37、irmation tests, except for pyrazinamidase test, can be replaced by real-time polymerase chain reaction (PCR) detection of ail-gene in accordance with ISO/TS 18867. Five confirmation tests (indole, trehalose, xylose, citrate, tween-esterase) have become optional. Test for salicin has been added as an

38、 optional (biotyping) test. Test for calcium requirements at 37C has been replaced by congo red magnesium-oxalate (CR-MOX) test. Three tests (oxidase, Kliglers agar and ornithine decarboxylase) have been deleted. The procedure for cold-enrichment of Y. enterocolitica has been added as Annex D; Perfo

39、rmance characteristics have been added to Annex C. Performance testing for the quality assurance of the culture media has been added to Annex B and Annex D.vi ISO 2017 All rights reservedBS EN ISO 10273:2017ISO 10273:2017(E)IntroductionThis document specifies a horizontal method for the detection of

40、 Yersinia enterocolitica associated with human disease. Because of the large variety of food and feed products, this horizontal method may not be appropriate in every detail for certain products, and for some other products it may be necessary to use different methods. Nevertheless, it is hoped that

41、 in all cases every attempt will be made to apply this horizontal method as far as possible and that deviations from this will only be made if absolutely necessary for technical reasons.The main changes, listed in the foreword, introduced in this document compared to ISO 10273:2003, are considered a

42、s major (see ISO 17468).When this document is next reviewed, account will be taken of all information then available regarding the extent to which this horizontal method has been followed and the reasons for deviations from this in the case of particular products.The harmonization of test methods ca

43、nnot be immediate and, for certain group of products, International Standards and/or national standards may already exist that do not comply with this horizontal method. It is hoped that when such standards are reviewed, they will be changed to comply with this document so that eventually the only r

44、emaining departures from this horizontal method will be those necessary for well-established technical reasons. ISO 2017 All rights reserved viiBS EN ISO 10273:2017This page deliberately left blankMicrobiology of the food chain Horizontal method for the detection of pathogenic Yersinia enterocolitic

45、aWARNING In order to safeguard the health of laboratory personnel, it is essential that tests for detecting pathogenic Yersinia enterocolitica are only undertaken in properly equipped laboratories, under the control of a skilled microbiologist, and that great care is taken in the disposal of all inc

46、ubated materials. Persons using this document should be familiar with normal laboratory practice. This document does not purport to address all of the safety aspects, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ens

47、ure compliance with any national regulatory conditions.1 ScopeThis document specifies a horizontal method for the detection of Y. enterocolitica associated with human disease. It is applicable to products intended for human consumption and the feeding of animals, and environmental samples in the are

48、a of food production and food handling.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition

49、 of the referenced document (including any amendments) applies.ISO 6887 (all parts), Microbiology of the food chain Preparation of test samples, initial suspension and decimal dilutions for microbiological examinationISO 7218 , Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinationsISO 11133:2014 , Microbiology of food, animal feed and water Preparation, production, storage and performance testing of culture media3 Terms and definitionsFor the purposes of this document, th