DIN EN ISO 7218-2014 Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinations (ISO 7218 2007 + Amd 1 2013) German version.pdf

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1、September 2014Translation by DIN-Sprachendienst.English price group 31No 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).I

2、CS 07.100.30!%;$s“2240180www.din.deDDIN EN ISO 7218Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations(ISO 7218:2007 + Amd 1:2013, Corrected version 2014-04-15);English version EN ISO 7218:2007 + A1:2013,English translation of DIN EN ISO

3、7218:2014-09Mikrobiologie von Lebensmitteln und Futtermitteln Allgemeine Anforderungen und Leitlinien fr mikrobiologische Untersuchungen(ISO 7218:2007 + Amd 1:2013, korrigierte Fassung 2014-04-15);Englische Fassung EN ISO 7218:2007 + A1:2013,Englische bersetzung von DIN EN ISO 7218:2014-09Microbiolo

4、gie des aliments Exigences gnrales et recommendations (ISO 7218:2007 + Amd 1:2013, Versioncorrige 2014-04-15);Version anglaise EN ISO 7218:2007 + A1:2013,Traduction anglaise de DIN EN ISO 7218:2014-09SupersedesDIN EN ISO 7218:2014-02www.beuth.deIn case of doubt, the German-language original shall be

5、 considered authoritative.Document comprises 95 pages09.14 DIN EN ISO 7218:2014-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 7218:2007 + A1:2013, Corrected version 2014-04-15) has been prepared by Technical Committee ISO/TC 34 “Food products”, Subcommittee SC 9

6、 “Microbiology” in collaboration with Technical Committee CEN/TC 275 “Food analysis Horizontal methods” (Secretariat: DIN, Germany), Working Group WG 6 “Microbiology of the food chain”, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). The responsible

7、German body involved in its preparation was the DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Committee NA 057-01-06 AA Mikrobiologische Lebensmitteluntersuchung einschlielich Schnellverfahren. This standard includ

8、es Amendment A1 approved by CEN on 2013-06-15. This document includes the corrected 2014-04-15 version of ISO 7218:2007 Amendment 1:2013. The start and finish of text introduced or altered by Amendment 1 is indicated in the text by tags !“. The DIN Standards corresponding to the International Standa

9、rds referred to in Clause 2 of this standard are as follows: ISO 835 DIN EN ISO 835 ISO 6887 (all parts) DIN EN ISO 6887 (all parts) ISO 8655 (all parts) DIN EN ISO 8655 (all parts) ISO 11133 DIN EN ISO 11133 ISO 16140-2 DIN EN ISO 16140-2 ISO 22174 DIN EN ISO 22174 Amendments This standard differs

10、from DIN EN ISO 7218:2007-11 as follows: a) Clause 5 “Apparatus and equipment” has been modified; b) Clause 6 “Preparation of glassware and other laboratory materials” has been modified; c) Clause 10 “Enumeration” has been modified; d) Annexes B, C and D have been modified; e) the document has been

11、editorially revised; f) the Bibliography has been supplemented. Compared with DIN EN ISO 7218:2014-02, the following corrections have been made: a) values in columns 4, 5, 7 and 8 in Table C.5 have been corrected; b) values in columns 4, 5, 6, 7, 8 and 9 in Table C.6 have been corrected; c) values i

12、n columns 4 and 9 in Table C.7 have been corrected. Previous editions DIN EN ISO 7218: 2007-11, 2014-02 DIN EN ISO 7218:2014-09 3 National Annex NA (informative) Bibliography DIN EN ISO 835, Laboratory glassware Graduated pipettes DIN EN ISO 6887 (all parts), Microbiology of food and animal feeding

13、stuffs Preparation of the test samples, of initial suspension and of decimal dilutions for microbiological examination DIN EN ISO 8655 (all parts), Piston-operated volumetric apparatus DIN EN ISO 11133, Microbiology of food, animal feed and water Preparation, production, storage and performance test

14、ing of culture media DIN EN ISO 16140-2, Microbiology of food and animal feed Method validation Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method DIN EN ISO 22174, Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the

15、 detection of food-borne pathogens General requirements and definitions DIN EN ISO 7218:2014-09 4 This page is intentionally blank EN ISO 7218 August 2007 + A1 August 2013 ICS 07.100.30 English Version Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiolog

16、ical examinations - Amendment 1 (ISO 7218:2007 + Amd 1:2013, Corrected version 2014-04-15) Microbiologie des aliments - Exigences gnrales et recommandations Amendement 1 (ISO 7218:2007 + Amd 1:2013, Version corrige 2014-04-15) Mikrobiologie von Lebensmitteln und Futtermitteln - Allgemeine Anforderun

17、gen und Leitlinien fr mikrobiologische Untersuchungen nderung 1 (ISO 7218:2007 + Amd 1:2013, korrigierte Fassung 2014-04-15) EN ISO 7218:2007 was approved by CEN on 2007-04-19 and Amendment A1:2013 on 2013-06-15. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipula

18、te 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 to the CEN-CENELEC Management Centre or to any CEN member. This European Sta

19、ndard 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 Centre has the same status as the official versions. CEN members are the na

20、tional 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, S

21、lovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7218:2007 + A1:2013 EEUROPEAN COMMITTEE FOR STA

22、NDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page Foreword to EN ISO 7218:2007 5 !Foreword to EN ISO 7218:2007/A1:2013 .5 Introduction .6 1 Scope 7 2 Normative references 7 3 Premises .8 3.1 General 8 3.2 Safety consi

23、derations .8 3.3 Laboratory design8 3.4 Laboratory areas 9 3.5 Layout and fittings of the premises .10 3.6 Cleaning and disinfection .11 4 Staff .11 4.1 General 11 4.2 Competence .12 4.3 Verification of on-going staff competence 12 4.4 Hygiene .12 5 Apparatus and equipment 12 5.1 General 12 5.2 Prot

24、ective cabinets 13 5.3 Balances and gravimetric diluters .14 5.4 Homogenizers, blenders and mixers .15 5.5 pH meter .16 5.6 Autoclave 17 5.7 Media preparator 18 5.8 Incubator .19 5.9 Refrigerator, cold-storage room .20 5.10 Freezer and deep freezer 21 5.11 Thermostatically controlled bath .21 5.12 S

25、teamers, including boiling-water baths 23 5.13 Sterilizing oven 23 5.14 Microwave oven .24 5.15 Glass washer 25 5.16 Optical microscope25 5.17 Gas burner or wire incinerator .2 5.18 Dispenser for culture media and reagents 26 5.19 Vortex mixer .27 5.20 Colony-counting device 27 5.21 Equipment for cu

26、lture in a modified atmosphere .28 5.22 Centrifuge .28 5.23 Hotplate and heating mantle .29 5.24 Spiral plater 29 5.25 Stills, deionizers and reverse-osmosis units 30 5.26 Timers and timing devices 31 5.27 Pipettes and pipettors .31 5.28 Thermometers and temperature-monitoring devices, including aut

27、omatic recorders 32 5.29 Immunomagnetic separator 33 5.30 Filtration system 34 6DIN EN ISO 7218:2014-09 EN ISO 7218:2007 + A1:2013 (E) 2 5.31 Other equipment and software 34 6 Preparation of glassware and other laboratory materials . 34 6.1 Preparation . 34 6.2 Sterilization or decontamination 34 6.

28、3 Disposable equipment and materials 35 6.4 Storage of clean glassware and materials 35 6.5 Management of sterile glassware and materials 35 6.6 Decontamination and disinfection . 35 6.7 Waste management . 36 6.8 Washing 36 7 Preparation and sterilization of culture media . 36 8 Laboratory samples 3

29、6 8.1 Sampling 36 8.2 Transport 37 8.3 Receipt 37 8.4 Storage . 38 8.5 Test portion 38 9 Examination . 39 9.1 Hygienic precautions during analysis . 39 9.2 Preparation of initial suspension and dilutions . 40 10 Enumeration . 41 10.1 General . 41 10.2 Enumeration using a solid medium . 41 10.3 Calcu

30、lation and expression of results obtained with solid media . 44 10.4 Enumeration of yeasts and moulds . 51 10.5 Enumeration using a liquid medium . 52 11 Detection method (qualitative method) . 58 11.1 General . 58 11.2 Principle . 58 11.3 Measurement of uncertainty 59 12 Confirmation methods 59 12.

31、1 General . 59 12.2 Preparation of a pure culture . 59 12.3 Grams stain (modified Hucker technique) . 59 12.4 Use of biochemical galleries for identification . 61 12.5 Use of nucleic probes for identification 61 12.6 Serological methods . 61 13 Test report 62 14 Validation of microbiological methods

32、 . 63 14.1 Validation of reference methods 63 14.2 Validation of alternative methods 63 14.3 Validation of in-house methods . 63 15 Quality assurance of results/quality control of performance . 63 15.1 Internal quality control 63 15.2 Reference strains 63 15.3 External quality assessment (proficienc

33、y testing) 64 Annex A (informative) Properties of some disinfectants 65 Annex B (informative) Confidence intervals for colony count technique . 66 B.1 Confidence intervals for colony count technique 66 B.2 Special cases with low numbers . 67 Annex C (normative) Determination of most probable number

34、. 71 !DIN EN ISO 7218:2014-09 EN ISO 7218:2007 + A1:2013 (E) 3 Annex D (normative) Counting of colonies with two dishes per dilution 81 D.1 Introduction 8 D.2 Counting of colonies .81 D.3 Method of calculation: General case (counting of total colonies or typical colonies) .82 D.4 Method of calculati

35、on: Case after identification or confirmation .83 D.5 Method of calculation: Estimated counts .84 D.6 Special cases (counting of typical or presumed suspect colonies) 85 D.7 Method of calculation: Special cases 86 Bibliography 9!DIN EN ISO 7218:2014-09 EN ISO 7218:2007 + A1:2013 (E) 4 18Foreword to

36、EN ISO 7218:2007 This document (EN ISO 7218:2007) has been prepared by Technical Committee ISO/TC 34 “Agricultural 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

37、 status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2008, and conflicting national standards shall be withdrawn at the latest by February 2008. Attention is drawn to the possibility that some of the elements of this document may be

38、the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Bel

39、gium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notic

40、e The text of ISO 7218:2007 has been approved by CEN as EN ISO 7218:2007 without any modification. !Foreword to EN ISO 7218:2007/A1:2013 This document (EN ISO 7218:2007/A1:2013) has been prepared by Technical Committee ISO/TC 34 “Food products” in collaboration with Technical Committee CEN/TC 275 “F

41、ood 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 text or by endorsement, at the latest by February 2014, and conflicting national standards shall be withdrawn at th

42、e latest by February 2014. 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 for identifying any or all such patent rights. All proprietary names in this document are given for the co

43、nvenience of users of this International Standard and do not constitute endorsements of these products by ISO. 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,

44、 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey

45、and the United Kingdom. Endorsement notice The text of ISO 7218:2007/Amd 1:2013 has been approved by CEN as EN ISO 7218:2007/A1:2013 without any modification.“ DIN EN ISO 7218:2014-09 EN ISO 7218:2007 + A1:2013 (E) 5 Introduction When conducting microbiological examinations, it is especially importa

46、nt that only those microorganisms which are present in the samples are isolated and enumerated; the microorganisms do not contaminate the environment. In order to achieve this, it is necessary to pay attention to personal hygiene and to use working techniques which ensure, as far as possible, exclus

47、ion of extraneous contamination. Since, in this International Standard, it is possible to give only a few examples of the precautions to be taken during microbiological examinations, a thorough knowledge of the microbiological techniques and of the microorganisms involved is essential. It is importa

48、nt that the examinations are conducted as accurately as possible, including monitoring and recording aspects that may affect results and calculation of the number of microorganisms and the uncertainty of the results. Ultimately, it is the responsibility of the head of the laboratory to judge whether

49、 the manipulations are safe and can be considered to be good laboratory practice. A large number of manipulations can, for example, unintentionally lead to cross-contamination, and the analyst should always verify the accuracy of the results given by his or her technique. In order to conduct the examinations correctly, it is necessary to take certain precautions when constructing and equipping the laboratory. Certain precautions must be taken, not only fo