EN ISO 18593-2018 Microbiology of the food chain - Horizontal methods for surface sampling.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Microbiology of the food chain - Horizontal methods for surface samplingBS EN ISO 18593:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18593 July 2018 ICS 07.100.30 English Version Microbiology of the food

2、 chain - Horizontal methods for surface sampling (ISO 18593:2018) Microbiologie de la chane alimentaire - Mthodes horizontales pour les prlvements de surface (ISO 18593:2018) Mikrobiologie der Lebensmittelkette - Horizontales Verfahren fr Probenahmetechniken von Oberflchen mittels Abklatschplatten u

3、nd Tupfer (ISO 18593:2018)This European Standard was approved by CEN on 30 May 2018. 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 a

4、nd 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 (English, French, German). A version in any other language made by translation under the

5、 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, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugosl

6、av 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT E

7、UROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18593:2018 ENational forewordThis British Standard

8、 is the UK implementation of EN ISO 18593:2018. It is identical to ISO 18593:2018. It supersedes BS ISO 18593:2004, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee AW/9, Microbiology.A list of organizations represented on this committee can be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

9、 on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 94561 8ICS 07.100.30Compliance with a

10、British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 18593:2018EUROPEAN STANDARD

11、 NORME EUROPENNE EUROPISCHE NORM EN ISO 18593 July 2018 ICS 07.100.30 English Version Microbiology of the food chain - Horizontal methods for surface sampling (ISO 18593:2018) Microbiologie de la chane alimentaire - Mthodes horizontales pour les prlvements de surface (ISO 18593:2018) Mikrobiologie d

12、er Lebensmittelkette - Horizontales Verfahren fr Probenahmetechniken von Oberflchen mittels Abklatschplatten und Tupfer (ISO 18593:2018)This European Standard was approved by CEN on 30 May 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions

13、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 to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in th

14、ree 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 Centre has the same status as the official versions. CEN members are the national standards b

15、odies of 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, Serbia, Slovakia, S

16、lovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means r

17、eserved worldwide for CEN national Members. Ref. No. EN ISO 18593:2018 EBS EN ISO 18593:2018EN ISO 18593:2018 (E) 3 European foreword This document (EN ISO 18593:2018) has been prepared by Technical Committee ISO/TC 34 “Food products“ in collaboration with Technical Committee CEN/TC 275 “Food analys

18、is - 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 text or by endorsement, at the latest by January 2019, and conflicting national standards shall be withdrawn at the latest

19、by January 2019. 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 identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizati

20、ons 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, Malta

21、 Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 18593:2018 has been approved by CEN as EN ISO 18593:2018 without any modification. BS EN ISO 18593:2018ISO 18593:2018(E)Foreword

22、 ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 25 Culture media and reagents 26 Equipment and consumables 37 Sampling procedure 37.1 General . 37.2 Sampling location . 37.3 Sampling area . 47.4 Time of sampling and frequency . 47.5 Sampling techniques 47.5

23、1 General 47.5.2 Contact plate method . 57.5.3 Stick swab method . 57.5.4 Sponge/cloth method 58 Storage and transport . 68.1 Contact plate . 68.2 Stick swab, sponge/cloth . 69 Microbiological analysis of samples . 69.1 Contact plate method 69.2 Stick swab/cloth/sponge method 610 Expression of resu

24、lts and calculation . 710.1 General . 710.2 Contact plate method 710.3 Method using stick swab, cloth or sponge. 711 Test report . 7Annex A (informative) Neutralizers 9Bibliography .11 ISO 2018 All rights reserved iiiContents PageBS EN ISO 18593:2018ISO 18593:2018(E)ForewordISO (the International Or

25、ganization 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 establ

26、ished 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 standardizati

27、on. 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

28、 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. Details of any

29、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

30、 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:

31、www .iso .org/iso/foreword .html.This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9, Microbiology.This second edition cancels and replaces the first edition (ISO 18593:2004), which has been technically revised. The main changes are as follows: recommendatio

32、ns on sampling procedure have been added, including information on sampling location, area and sampling time; examples of neutralizers have been added as Annex A.iv ISO 2018 All rights reservedBS EN ISO 18593:2018ISO 18593:2018(E)IntroductionIt can be important to determine the presence of, or the n

33、umber of microbes on, the surfaces of utensils, work surfaces and other equipment in the food chain environment in order to estimate the level of contamination in the food chain environment.This document describes horizontal methods for surface sampling. ISO 2018 All rights reserved vBS EN ISO 18593

34、2018Microbiology of the food chain Horizontal methods for surface sampling1 ScopeThis document specifies horizontal methods for sampling techniques using contact plates, stick swabs, sponges and cloths on surfaces in the food chain environment in order to detect and enumerate culturable microorgani

35、sms such as pathogenic or non-pathogenic bacteria or yeasts and moulds.NOTE The term “environment” means any item in contact with the food product or likely to represent a contamination or recontamination source; for example, material, premises or operators.This document does not apply to the valida

36、tion of cleaning and disinfection procedures.This document does not apply to sampling techniques for primary production samples, which are covered by ISO 13307. Sampling techniques for carcasses are covered by ISO 17604. Sampling techniques for analysis of noroviruses and hepatitis A viruses are cov

37、ered by ISO 15216-1.This document does not give advice on sampling frequency, the number of sampling points, or the need to rotate sampling points, as these are chosen on a case-by-case basis.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of

38、their content constitutes requirements 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 6887-1, Microbiology of the food chain Preparation of test samples, initial susp

39、ension and decimal dilutions for microbiological examination Part 1: General rules for the preparation of the initial suspension and decimal dilutionsISO 6887-5, Microbiology of food and animal feeding stuffs Preparation of test samples, initial suspension and decimal dilutions for microbiological e

40、xamination Part 5: Specific rules for the preparation of milk and milk productsISO 7218, Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinationsISO 11133, Microbiology of food, animal feed and water Preparation, production, storage and perfor

41、mance testing of culture mediaISO 16140-2, Microbiology of the food chain Method validation Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method3 Terms and definitionsNo terms and definitions are listed in this document.ISO and IEC maintain terminologic

42、al databases for use in standardization at the following addresses: ISO Online browsing platform: available at https: /www .iso .org/obp IEC Electropedia: available at http: /www .electropedia .org/INTERNATIONAL STANDARD ISO 18593:2018(E) ISO 2018 All rights reserved 1BS EN ISO 18593:2018ISO 18593:2

43、018(E)4 PrincipleSampling schemes aim to evaluate microbial contamination levels of surfaces from the food chain environment in order to implement corrective actions to avoid food contamination by microorganisms. Ineffective sampling programmes or techniques may result in the non-detection of microo

44、rganisms when they are present.This document describes surface sampling methods to detect or enumerate microorganisms from surfaces in the food chain environment. Different sampling techniques are described, including contact plates, stick swabs, cloths and sponges.This document also gives recommend

45、ations on the locations and areas to be sampled and the most appropriate sampling time.According to the device and the microorganism to be detected or enumerated, determination of the microbial contamination of the surface can be performed by sampling of the surface, and analysis according to specif

46、ic standards.5 Culture media and reagentsFollow current laboratory practice as specified in ISO 7218. Follow performance testing of culture media as specified in ISO 11133.5.1 Diluent.In general, the diluent is sterile buffered peptone water, peptone salt as specified in ISO 6887-1, peptone solution

47、 at 1 g/l or quarter-strength Ringers solution as specified in ISO 6887-5, with neutralizer(s) (5.3) added if necessary.NOTE To extend transport time, an appropriate transport diluent can be added, if properly validated.5.2 Medium for contact plate.Plates (6.1) may vary in diameter or area, accordin

48、g to the type of surface to be sampled. The medium is chosen according to the ISO method for the microorganism(s) of concern, with neutralizer(s) (5.3) added if necessary. The medium shall form a convex meniscus with the contact plate.Alternative media formulations shall be supported by a validation

49、 study as specified in ISO 16140-2.5.3 Neutralizer.In cases where residues of disinfectants are expected, appropriate neutralizer(s) should be added to the diluent (5.1) or media (5.2) before sampling, to prevent any inhibitory effect of the disinfectants on the growth of microorganisms.Do not add neutralizer to the diluent when no residual disinfectant is expected9. A neutralizer used to quench residual disinfectant can have a slight deleterious impact on bacterial cells and it is likely that such an impact would be gre