《BS-EN-ISO-7218-2007.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-7218-2007.pdf（76页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 7218:2007 Incorporating corrigendum May 2009 Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations ICS 07.100.30 ? Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI BS EN I
2、SO 7218:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2008 BSI 2009 ISBN 978 0 580 66968 2 National foreword This British Standard is the UK implementation of EN ISO 7218:2007. It supersedes BS 4285-2.1:1984, BS 4285-2.3:1984,
3、 BS 4285-2.6:1984 and BS 5763-0:1996, which are withdrawn.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. BS EN ISO 7218 describes the requirements and
4、 recommendations for good laboratory practice in a microbiology laboratory that help to ensure the general quality of food testing. Laboratories would be expected to take account of the principles described in BS EN ISO 7218 in order to demonstrate competence in accordance with ISO/IEC 17025. This p
5、ublication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication Date Comments Correction to the Super
6、session details in the National Foreword 31 May 2009 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7218 August 2007 ICS 07.100.30 English Version Microbiology of food and animal feeding stuffs - Gen
7、eral requirements and guidance for microbiological examinations (ISO 7218:2007) Microbiologie des aliments - Exigences gnrales et recommendations (ISO 7218:2007) Mikrobiologie von Lebensmitteln und Futtermitteln - Allgemeine Anforderungen und Anleitung fr mikrobiologische Untersuchungen (ISO 7218:20
8、07) This European Standard was approved by CEN on 19 April 2007. 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 r
9、eferences concerning such national standards may be obtained on application to the CEN 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
10、ber into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
11、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050
12、 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7218:2007: E Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 7218:2007) has been prepared b
13、y 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 status of a national standard, either by publication of an identic
14、al text or by endorsement, at the latest by February 2008, and conflicting national standards shall be withdrawn at the latest by February 2008. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Sta
15、ndard: Austria, Belgium, 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
16、. Endorsement notice The text of ISO 7218:2007 has been approved by CEN as a EN ISO 7218:2007 without any modification. BS EN ISO 7218:2007 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 2 Normativ
17、e references. 1 3 Premises 2 3.1 General. 2 3.2 Safety considerations. 2 3.3 Laboratory design. 2 3.4 Laboratory areas. 3 3.5 Layout and fittings of the premises 4 3.6 Cleaning and disinfection 5 4 Staff 5 4.1 General. 5 4.2 Competence 6 4.3 Verification of on-going staff competence. 6 4.4 Hygiene 6
18、 5 Apparatus and equipment . 6 5.1 General. 6 5.2 Protective cabinets. 7 5.3 Balances and gravimetric diluters 8 5.4 Homogenizers, blenders and mixers 9 5.5 pH meter 10 5.6 Autoclave. 11 5.7 Media preparator. 12 5.8 Incubator 12 5.9 Refrigerator, cold-storage room 13 5.10 Freezer and deep freezer .
19、14 5.11 Thermostatically controlled bath 15 5.12 Steamers, including boiling-water baths 16 5.13 Sterilizing oven . 17 5.14 Microwave oven 17 5.15 Glass washer. 18 5.16 Optical microscope. 19 5.17 Gas burner or wire incinerator 19 5.18 Dispenser for culture media and reagents. 20 5.19 Vortex mixer 2
20、0 5.20 Colony-counting device. 21 5.21 Equipment for culture in a modified atmosphere 22 5.22 Centrifuge 22 5.23 Hotplate and heating mantle 23 5.24 Spiral plater . 23 5.25 Stills, deionizers and reverse-osmosis units. 24 5.26 Timers and timing devices. 24 5.27 Pipettes and pipettors 25 5.28 Thermom
21、eters and temperature-monitoring devices, including automatic recorders. 26 5.29 Immunomagnetic separator. 27 5.30 Filtration system. 27 5.31 Other equipment and software 28 BS EN ISO 7218:2007 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI iv 6 Preparatio
22、n of glassware and other laboratory materials 28 6.1 Preparation 28 6.2 Sterilization/decontamination28 6.3 Disposable equipment and materials .28 6.4 Storage of clean glassware and materials .28 6.5 Management of sterile glassware and materials .29 6.6 Use of decontamination and disinfection.29 6.7
23、 Waste management 29 6.8 Washing .30 7 Preparation and sterilization of culture media.30 8 Laboratory samples30 8.1 Sampling30 8.2 Transport31 8.3 Receipt .31 8.4 Storage.32 8.5 Test portion32 9 Examination.32 9.1 Hygienic precautions during analysis 32 9.2 Preparation of initial suspension and dilu
24、tions.34 10 Enumeration 34 10.1 General.34 10.2 Enumeration using a solid medium 35 10.3 Calculation and expression of results obtained with solid media.37 10.4 Enumeration of yeasts and moulds 43 10.5 Enumeration using a liquid medium.44 11 Detection method (qualitative method) 49 11.1 General.49 1
25、1.2 Principle.50 11.3 Measurement of uncertainty50 12 Confirmation methods50 12.1 General.50 12.2 Preparation of a pure culture.50 12.3 Grams stain (modified Hucker technique).50 12.4 Use of biochemical galleries for identification 52 12.5 Use of nucleic probes for identification .52 12.6 Serologica
26、l methods.53 13 Test report53 14 Validation of microbiological methods.54 14.1 Validation of reference methods .54 14.2 Validation of alternative methods54 14.3 Validation of in-house methods.54 15 Quality assurance of results/quality control of performance.54 15.1 Internal quality control .54 15.2
27、Reference strains54 15.3 External quality assessment (proficiency testing)55 Annex A (informative) Properties of some disinfectants56 Annex B (normative) Determination of most probable number (MPN).57 Bibliography .64 BS EN ISO 7218:2007 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09
28、, Uncontrolled Copy, (c) BSI v Foreword ISO (the International 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 intere
29、sted 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 liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
30、Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the tec
31、hnical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO
32、 shall not be held responsible for identifying any or all such patent rights. ISO 7218 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9, Microbiology, in collaboration with CEN Technical Committee CEN/TC 275, Food analysis Horizontal methods. This third edition cancels
33、 and replaces the second edition (ISO 7218:1996), which has been technically revised. It also incorporates the Amendment ISO 7218:1996/Amd.1:2001. BS EN ISO 7218:2007 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI vi Introduction When conducting microbiolo
34、gical examinations, it is especially important 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 techniq
35、ues which ensure, as far as possible, exclusion 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 microor
36、ganisms involved is essential. It is important 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
37、 the head of the laboratory to judge whether 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 o
38、r 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 for reasons of hygiene, but also to ensure good reproducibility of the results. It is not possible
39、to specify all the precautions to be taken in all circumstances, but this International Standard at least provides the main measures to be taken when preparing, sterilizing, storing the media, and using the equipment. If the guidance given in this International Standard is followed, this will also c
40、ontribute towards maintaining the health and safety of personnel. Additional information on this subject is to be found in the literature listed in the Bibliography. In order to distinguish the guidance in this International Standard, it has been printed in a different typeface (Times New Roman). BS
41、 EN ISO 7218:2007 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI 1 Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations 1 Scope This International Standard gives general requirements and guidance
42、/options intended for three main uses: implementation of ISO/TC 34/SC 9 or ISO/TC 34/SC 5 standards for detection or enumeration of microorganisms, named hereafter “specific standards”; good laboratory practice for food microbiological laboratories (the purpose is not to detail them in this Internat
43、ional Standard, manuals are available for that purpose); guidance for accreditation of food microbiological laboratories (this International Standard describes the technical requirements according to Annex B of ISO/IEC 17025:2005 for the accreditation of a microbiological laboratory by national orga
44、nizations). The requirements of this International Standard supersede the corresponding ones of existing specific standards. Additional instructions in the field of molecular biology examinations are specified in ISO 22174. This International Standard covers examination for bacteria, yeasts and moul
45、ds and can be used if supplemented with specific guidance for prions, parasites and viruses. It does not cover the examination for toxins or other metabolites (e.g. amines) from microorganisms. This International Standard applies to the microbiology of food, animal feeding stuffs, the food productio
46、n environment and the primary production environment. The purpose of this International Standard is to help to ensure the validity of food microbiology examinations, to assist in ensuring that the general techniques used for conducting these examinations are the same in all laboratories, to help ach
47、ieve homogeneous results in different laboratories, and to contribute towards the safety of the laboratory personnel by preventing risks of infection. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edit
48、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 835 (all parts), Laboratory glassware Graduated pipettes ISO 6887 (all parts), Microbiology of food and animal feeding stuffs Preparation of test samples, initial suspensi
49、on and decimal dilutions for microbiological examination ISO 8199, Water quality General guidance on the enumeration of micro-organisms by culture ISO 8261, Milk and milk products General guidance for the preparation of test samples, initial suspensions and decimal dilutions for microbiological examination BS EN ISO 7218:2007 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:09, Uncontrolled Copy, (c) BSI 2 ISO 8655-1, Piston-operated volumetric apparatus Part 1: Terminolog