1、Microbiology of the food chain - Horizontal method for the detection and enumeration of EnterobacteriaceaePart 1: Detection of Enterobacteriaceae (ISO 21528-1:2017) BS EN ISO 21528-1:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENN
2、E EUROPISCHE NORM EN ISO 21528-1 July 2017 ICS 07.100.30 English Version Microbiology of the food chain - Horizontal method for the detection and enumeration of Enterobacteriaceae - Part 1: Detection of Enterobacteriaceae (ISO 21528-1:2017) Microbiologie de la chane alimentaire - Mthode horizontale
3、par la recherche et le dnombrement des Enterobacteriaceae - Partie 1: Recherche des Enterobacteriaceae (ISO 21528-1:2017) Mikrobiologie der Lebensmittelkette - Horizontales Verfahren fr den Nachweis und die Zhlung von Enterobacteriaceae Teil 1: Nachweis von Enterobacteriaceae (ISO 21528-1:2017) This
4、 European Standard was approved by CEN on 27 April 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 reference
5、s 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 versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN mem
6、ber 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 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fr
7、ance, Germany, Greece, Hungary, Iceland, 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 EURO
8、PISCHES KOMITEE FR NORMUNG CEN-CENELEC 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 21528-1:2017 ENational forewordThis British Standard is the UK implementation of E
9、N ISO 21528-1:2017. It supersedes BS ISO 21528-1:2004, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee AW/9, Microbiology.A list of organizations represented on this committee can be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 not purpor
10、t 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 70335 5ICS 07.100.30Compliance with a British Standard cannot confer immunity from legal obligation
11、s.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 215281:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21528-1 July 2017 I
12、CS 07.100.30 English Version Microbiology of the food chain - Horizontal method for the detection and enumeration of Enterobacteriaceae - Part 1: Detection of Enterobacteriaceae (ISO 21528-1:2017) Microbiologie de la chane alimentaire - Mthode horizontale par la recherche et le dnombrement des Enter
13、obacteriaceae - Partie 1: Recherche des Enterobacteriaceae (ISO 21528-1:2017) Mikrobiologie der Lebensmittelkette - Horizontales Verfahren fr den Nachweis und die Zhlung von Enterobacteriaceae Teil 1: Nachweis von Enterobacteriaceae (ISO 21528-1:2017) This European Standard was approved by CEN on 27
14、 April 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 may be
15、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 notified to th
16、e 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, Iceland, Ire
17、land, 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-CENELEC Manag
18、ement 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 21528-1:2017 EBS EN ISO 215281:2017EN ISO 21528-1:2017 (E) 2 European foreword This document (EN ISO 21528-1:2017) has been pr
19、epared by Technical Committee ISO/TC 34 “Food products” in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical te
20、xt or by endorsement, at the latest by January 2018, and conflicting national standards shall be withdrawn at the latest by January 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identi
21、fying any or all such patent rights. 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 organizations of the following countries are bound to implem
22、ent 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, Malta, Netherlands, Norway, Poland, Portugal, Romania,
23、Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21528-1:2017 has been approved by CEN as EN ISO 21528-1:2017 without any modification. ISO 21528-1:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and
24、definitions . 14 Principle 24.1 Enrichment in non-selective medium . 24.2 Isolation and selection for confirmation 24.3 Confirmation . 25 Diluent, culture media and reagent 26 Equipment and consumables 27 Sampling 38 Preparation of test sample . 39 Procedure. 39.1 General . 39.2 Test portion and ini
25、tial suspension . 49.3 Enrichment . 49.4 Isolation and selection for confirmation 49.4.1 Isolation . 49.4.2 Selection of colonies for confirmation 49.5 Subculturing selected colonies 49.6 Biochemical confirmation tests 49.6.1 Oxidase reaction . 49.6.2 Fermentation test 510 Expression of results 511
26、Precision . 511.1 Interlaboratory study 511.2 Sensitivity 511.3 Specificity 512 Test report . 513 Quality assurance 6Annex A (informative) Enumeration by MPN technique 7Annex B (normative) Culture media and reagents .10Annex C (informative) Method validation studies and performance characteristics .
27、15Bibliography .17 ISO 2017 All rights reserved iiiContents PageBS EN ISO 215281:2017ISO 21528-1:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 24.1 Enrichment in non-selective medium . 24.2 Isolation and selection for confirmation 24.3 Conf
28、irmation . 25 Diluent, culture media and reagent 26 Equipment and consumables 27 Sampling 38 Preparation of test sample . 39 Procedure. 39.1 General . 39.2 Test portion and initial suspension . 49.3 Enrichment . 49.4 Isolation and selection for confirmation 49.4.1 Isolation . 49.4.2 Selection of col
29、onies for confirmation 49.5 Subculturing selected colonies 49.6 Biochemical confirmation tests 49.6.1 Oxidase reaction . 49.6.2 Fermentation test 510 Expression of results 511 Precision . 511.1 Interlaboratory study 511.2 Sensitivity 511.3 Specificity 512 Test report . 513 Quality assurance 6Annex A
30、 (informative) Enumeration by MPN technique 7Annex B (normative) Culture media and reagents .10Annex C (informative) Method validation studies and performance characteristics .15Bibliography .17 ISO 2017 All rights reserved iiiContents PageBS EN ISO 215281:2017ISO 21528-1:2017(E)ForewordISO (the Int
31、ernational 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 which a technical committee ha
32、s 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 all matters of electrotechnical
33、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. This document was drafted in acc
34、ordance 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 or all such patent rights. De
35、tails 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
36、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 to Trade (TBT) see the following URL: www .iso .org/ iso/ fo
37、reword .htmlThis document was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/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 te
38、chnical cooperation between ISO and CEN (Vienna Agreement).This second edition cancels and replaces the first edition (ISO 21528-1:2004), which has been technically revised with the following main changes: the MPN method has become an informative Annex A; the pre-enrichment step in BPW followed by e
39、nrichment in EE broth has been changed to enrichment in BPW7and confirmation now takes place in Glucose OF medium instead of using glucose agar; performance testing for the quality assurance of the culture media has been added; performance characteristics for this method have been added to Annex C.A
40、 list of all the parts in the ISO 21528 series can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 215281:2017ISO 21528-1:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
41、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 that committee. International organizations, governmental and non-government
42、al, 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.The procedures used to develop this document and those intended for its further maintenance are described in the I
43、SO/IEC Directives, 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 possi
44、bility 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of
45、 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 a
46、s 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 .htmlThis document was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food an
47、alysis 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 second edition cancels and replaces the first edition (ISO 21528-1
48、:2004), which has been technically revised with the following main changes: the MPN method has become an informative Annex A; the pre-enrichment step in BPW followed by enrichment in EE broth has been changed to enrichment in BPW7and confirmation now takes place in Glucose OF medium instead of using
49、 glucose agar; performance testing for the quality assurance of the culture media has been added; performance characteristics for this method have been added to Annex C.A list of all the parts in the ISO 21528 series can be found on the ISO website.iv ISO 2017 All rights reserved ISO 21528-1:2017(E)IntroductionThis document is intended to provide general guidance for the examination of products not dealt with by existing International Standards and to be taken into account by organizations preparing microbiological test methods
