1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21199-8 SANS 7218:2008 Edition 2 ISO 7218:2007 Edition 3SOUTH AFRICAN NATIONAL STANDARD Microbiology of food and animal feeding stuffs Gen
4、eral requirements and guidance for microbiological examinations This national standard is the identical implementation of ISO 7218:2007 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan road groenkloof private b
5、ag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 7218:2008 Edition 2 ISO 7218:2007 Edition 3 Table of changes Chang
6、e No. Date Scope National foreword This South African Standard was approved by National Committee StanSA TC 5140.26, Microbiological evaluation of foods, feeds and beverages, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This SANS docum
7、ent was published in May 2008. This SANS document supersedes SANS 7218:1996 (edition 1, ISO amendment 1, and national amendment 1). This standard may only be used and printed by approved subscription and freemailing clients of the SABS. Reference number ISO 7218:2007(E) ISO 2007INTERNATIONAL STANDAR
8、D ISO 7218 Third edition 2007-08-15 Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations Microbiologie des aliments Exigences gnrales et recommendations SANS 7218:2008This standard may only be used and printed by approved subscription and
9、freemailing clients of the SABS.ISO 7218:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer p
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12、al Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission
13、in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reservedSAN
14、S 7218:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 7218:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Premises 2 3.1 General. 2 3.2 Safety consideration
15、s. 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 5 Apparatus and equipment . 6 6 Preparation of glassware and other
16、laboratory materials 28 6.1 Preparation 28 6.2 Sterilization/decontamination 28 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 Waste management 29
17、6.8 Washing . 30 7 Preparation and sterilization of culture media 30 8 Laboratory samples 30 8.1 Sampling 30 8.2 Transport . 31 8.3 Receipt . 31 8.4 Storage. 32 8.5 Test portion . 32 9 Examination. 32 9.1 Hygienic precautions during analysis 32 9.2 Preparation of initial suspension and dilutions 34
18、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 11.2 Pr
19、inciple. 50 11.3 Measurement of uncertainty 50 SANS 7218:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 7218:2007(E) iv ISO 2007 All rights reserved12 Confirmatory methods 50 12.1 General . 50 12.2 Preparation of a pure culture. 50 12.
20、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 Serological methods. 53 13 Test report 53 14 Validation of microbiological methods. 54 14.1 Validation of reference methods . 54 14.2 Validati
21、on of alternative methods 54 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 Reference strains 54 15.3 External quality assessment (proficiency testing) 55 Annex A (informative) Properties of some disi
22、nfectants 56 Annex B (normative) Determination of most probable number (MPN). 57 Bibliography . 64 SANS 7218:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 7218:2007(E) ISO 2007 All rights reserved v Foreword ISO (the International Org
23、anization 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 establi
24、shed 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 standardizatio
25、n. 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 technical committees are circulated to the member bodies for voting.
26、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 shall not be held responsible for identifying any or all such pat
27、ent 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 and replaces the second edition (ISO 7218:1996), which has been t
28、echnically revised. It also incorporates the Amendment ISO 7218:1996/Amd.1:2001. SANS 7218:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 7218:2007(E) vi ISO 2007 All rights reservedIntroduction When conducting microbiological examinat
29、ions, 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 techniques which ensu
30、re, 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 microorganisms involv
31、ed 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 the head of t
32、he 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 or her techniqu
33、e. 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 to specify all
34、 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 contribute towa
35、rds 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). SANS 7218:2008Th
36、is standard may only be used and printed by approved subscription and freemailing clients of the SABS.INTERNATIONAL STANDARD ISO 7218:2007(E) ISO 2007 All rights reserved 1 Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations 1 Scope This
37、International Standard gives general requirements and guidance/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 la
38、boratories (the purpose is not to detail them in this International 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
39、accreditation of a microbiological laboratory by national organizations). 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 Internati
40、onal Standard covers examination for bacteria, yeasts and moulds 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 m
41、icrobiology of food, animal feeding stuffs, the food production 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 th
42、ese examinations are the same in all laboratories, to help achieve 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 app
43、lication 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 835 (all parts), Laboratory glassware Graduated pipettes ISO 6887 (all parts), Microbiology of food and anima
44、l feeding stuffs Preparation of test samples, initial suspension 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, init
45、ial suspensions and decimal dilutions for microbiological examination SANS 7218:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 7218:2007(E) 2 ISO 2007 All rights reservedISO 8655-1, Piston-operated volumetric apparatus Part 1: Terminol
46、ogy, general requirements and user recommendations ISO/TS 11133 (all parts), Microbiology of food and animal feeding stuffs Guidelines on preparation and production of culture media ISO 16140, Microbiology of food and animal feeding stuffs Protocol for the validation of alternative methods ISO/TS 19
47、036, Microbiology of food and animal feeding stuffs Guidelines for the estimation of measurement uncertainty for quantitative determinations ISO 22174, Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and de
48、finitions 3 Premises 3.1 General This clause gives general requirements, e.g. the principles of design and organization, for the layout of a microbiological laboratory. Examination of primary production stage samples (especially for sample reception and sample preparation) shall be separated from ex
49、amination of other samples to reduce the risks of cross-contamination. 3.2 Safety considerations The laboratory design shall comply with safety requirements which will depend on the type of microorganism. To this end, microorganisms are classified in four risk categories: Risk category 1 (no or very low risk to the individual and to the community). A microorganism that is unlikely to cause human or animal disease. Risk category 2 (moderate risk to the individual, low risk to the community). A pathogen that
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