EN ISO 19020-2017 en Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs.pdf

1、Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs (ISO 19020:2017)BS EN ISO 19020:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN

2、ISO 19020 June 2017 ICS 07.100.30 English Version Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs (ISO 19020:2017) Microbiologie de la chane alimentaire - Mthode horizontale de dtection des entrotoxines staphylococciqu

3、es par test immuno-enzymatique dans les aliments (ISO 19020:2017) Mikrobiologie der Lebensmittelkette - Horizontales Verfahren fr den immunenzymatischen Nachweis von Staphylokokken-Enterotoxinen in Lebensmitteln (ISO 19020:2017) This European Standard was approved by CEN on 14 May 2017. CEN members

4、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 obtained on application t

5、o 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 the CEN-CENELEC Management

6、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, Ireland, Italy, Latvia, Lith

7、uania, 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 Management Centre: Avenue Marn

8、ix 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 19020:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 19020:2017. It is identical to ISO 19020:2017.The UK participatio

9、n 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 purport to include all the necessary provisions of a contract. Users are responsible for its correc

10、t application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 84392 1ICS 07.100.30Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strateg

11、y Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 19020:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19020 June 2017 ICS 07.100.30 English Version Microbiology of the food chain - Horizontal method for the immun

12、oenzymatic detection of staphylococcal enterotoxins in foodstuffs (ISO 19020:2017) Microbiologie de la chane alimentaire - Mthode horizontale de dtection des entrotoxines staphylococciques par test immuno-enzymatique dans les aliments (ISO 19020:2017) Mikrobiologie der Lebensmittelkette - Horizontal

13、es Verfahren fr den immunenzymatischen Nachweis von Staphylokokken-Enterotoxinen in Lebensmitteln (ISO 19020:2017) This European Standard was approved by CEN on 14 May 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europ

14、ean 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 versions

15、 (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 Austria, Bel

16、gium, 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, Swede

17、n, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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

18、 national Members. Ref. No. EN ISO 19020:2017 EBS EN ISO 19020:2017EN ISO 19020:2017 (E) 3 European foreword This document (EN ISO 19020:2017) has been prepared CEN/TC 275 “Food analysis - Horizontal methods” the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 3

19、4 “Food products”. 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 December 2017, and conflicting national standards shall be withdrawn at the latest by December 2017. Attention is drawn to the po

20、ssibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying 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.

21、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, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Ger

22、many, 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 notice The text of ISO 19020:2017 has been approved by CEN as EN IS

23、O 19020:2017 without any modification. ISO 19020:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references . 13 Terms and definitions 14 Principle . 25 Reagents . 26 Apparatus . 27 Sampling 38 Procedure . 38.1 Preparation of test portion . 38.2 Storage of the test sample . 38.3 Extraction 48

24、.4 Concentration of the extract (mandatory for milk and dairy products) . 58.5 Recovery of the concentrated extract 58.6 Storage and steps before detection . 68.7 Detection 68.8 Performance criteria 69 Quality control . 610 Expression of results . 711 Confirmation . 712 Performance characteristics o

25、f the method . 713 Test report . 9Annex A (informative) Results of interlaboratory studies: 2013.10Annex B (informative) Results of interlaboratory studies: 2014.15Annex C (informative) Note on interferences .21Bibliography .22 ISO 2017 All rights reserved iiiContents PageBS EN ISO 19020:2017ISO 190

26、20:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references . 13 Terms and definitions 14 Principle . 25 Reagents . 26 Apparatus . 27 Sampling 38 Procedure . 38.1 Preparation of test portion . 38.2 Storage of the test sample . 38.3 Extraction 48.4 Concentration of the extract (mandatory for

27、 milk and dairy products) . 58.5 Recovery of the concentrated extract 58.6 Storage and steps before detection . 68.7 Detection 68.8 Performance criteria 69 Quality control . 610 Expression of results . 711 Confirmation . 712 Performance characteristics of the method . 713 Test report . 9Annex A (inf

28、ormative) Results of interlaboratory studies: 2013.10Annex B (informative) Results of interlaboratory studies: 2014.15Annex C (informative) Note on interferences .21Bibliography .22 ISO 2017 All rights reserved iiiContents PageBS EN ISO 19020:2017ISO 19020:2017(E)ForewordISO (the International Organ

29、ization 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 has been establish

30、ed 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 standardization.

31、 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 accordance with th

32、e 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. Details of any pa

33、tent 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.

34、 For an explanation on the voluntary nature of standards, 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: w

35、ww .iso .org/ iso/ foreword .html.This 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 TC 34, Food products, Subcommittee SC 9, Microbiology, in accordance with t

36、he agreement on technical cooperation between ISO and CEN (Vienna Agreement).iv ISO 2017 All rights reservedBS EN ISO 19020:2017ISO 19020:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of pr

37、eparing 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, i

38、n 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 ISO/I

39、EC 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 possibili

40、ty 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 pat

41、ent 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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to

42、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/ foreword .html.This document was prepared by the European Committee for Standardization (CEN) Techni

43、cal Committee CEN/TC 275, Food Analysis Horizontal methods, in collaboration with ISO Technical Committee TC 34, Food products, Subcommittee SC 9, Microbiology, in accordance with the agreement on technical cooperation between ISO and CEN (Vienna Agreement).iv ISO 2017 All rights reserved ISO 19020:

44、2017(E)IntroductionStaphylococcal enterotoxins (SEs) are proteins that can be produced in foods, by certain strains of the coagulase positive staphylococci (CPS), mainly Staphylococcus aureus. These SEs are heat and acid stable toxins that cause nausea, vomiting, abdominal pain and diarrhoea when in

45、gested. Due to their stability SEs might still be present even when coagulase positive staphylococci cannot be detected. SEs consist of a family of more than 20 structurally-related globular monomeric proteins with molecular weights of 19 kDa to 30 kDa.1 These proteins are relatively stable under ch

46、anging environmental conditions, such as heat treatment, freezing and change in pH; moreover, they are resistant to proteolytic digestion. Typically, and depending on the sensitivity of affected individuals, nanogram (ng) amounts of enterotoxin can cause intoxication with the symptoms described abov

47、e. Due to the influence of SEs on human health, the European Union has adopted legislation in order to increase consumer protection by defining microbiological criteria for foodstuffs, such as CPS enumeration and detection of SEs.2Several methods have been developed for the detection and/or quantifi

48、cation of SEs. Some of these methods are based on enzyme immunoassay (EIA). Other methods are based on the chemical analysis using liquid chromatography with tandem mass spectrometry (LC-MS/MS) for the detection and quantification of SEs. As these latter methods are currently under development, EIA

49、methods have been chosen as the starting point for standardization of a detection method for SEs.The aim is to detect SEs using commercially available test kits. This document describes the protocol for the extraction of SEs from food samples. Moreover, criteria for the performance of the kits have been evaluated on five types of food matrices before use based on the criteria given in this document.Response rates of different staphylococcal food poisoning outbreaks were modelled as a function of ingested doses.3For this purpose, data f