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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | DRAFT FOR DEVELOPMENT DD ENV ISO 11133-1:2
2、000 ICS 03.120.10; 07.100.30 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Microbiology of food and animal feeding stuffs Guidelines on quality assurance and performance testing of culture media Part 1: General guidelines on quality assurance of culture media in the laborato
3、ry Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This Draft for Development, having been prepared under the direction of the Consumer Products and Services Sector Committee, was published under the authority
4、of the Standards Committee and comes into effect on 15 September 2000 BSI 09-2000 ISBN 0 580 32986 0 DD ENV ISO 11133-1:2000 Amendments issued since publication Amd. No.DateComments National foreword This Draft for Development is the English language version of ENV ISO 11133-1:2000. This publication
5、 is not to be regarded as a British Standard. It is being isued in the Draft for Development series of publications and is of a provisional nature because of the need to determine the extent to which this horizontal method can be followed and also the reasons for deviations from this method that may
6、 be necessary in the case of particular products. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the Eu
7、ropean organization responsible for its conversion into a European Standard. A review of this publication will be initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of its three-year life. The commencement of the review perio
8、d will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments should
9、 be sent in writing to the Secretary of BSI Technical Committee AW/9, Microbiology, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can
10、be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Fin
11、d facility of the BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, the ENV ISO title page, pages 2 to 17 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy:
12、 London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN PRESTANDARD PRNORME EUROPENNE EUROPISCHE VORNORM ENV ISO 11133-1 June 2000 ICS 01.040.07; 07.100.30 English version Microbiology of food and animal feeding stuffs - Gu
13、idelines on preparation and production of culture media - Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory (ISO/TR 11133-1:2000) Microbiologie des aliments - Guide pour la prparation et la production des milieux de culture - Partie 1: Guide gnral
14、 pour lassurance de la qualit pour la prparation des milieux de culture en laboratoire (ISO/TR 11133-1:2000) Mikrobiologie von Lebensmitteln und Futtermitteln - Anleitungen fr die Zubereitung und Herstellung von Nhrmedien - Teil 1: Allgemeine Anleitungen fr die Qualittssicherung bei der Zubereitung
15、von Nhrmedien im Laboratorium (ISO/TR 11133-1:2000) This European Prestandard (ENV) was approved by CEN on 1 August 1999 as a prospective standard for provisional application. The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested
16、 to submit their comments, particularly on the question whether the ENV can be converted into a European Standard. CEN members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly at national level in an appropriate form. It is permis
17、sible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible conversion of the ENV into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Icelan
18、d, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitatio
19、n in any form and by any means reserved worldwide for CEN national Members. Ref. No. ENV ISO 11133-1:2000 E Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 ENV ISO 11133-1:2000 Contents Foreword. 3 1Scop
20、e. 3 2Normative references. 4 3Terminology 4 3.1General. 4 3.2Terminology of quality assurance 4 3.3Terminology of culture media. 5 3.4Terminology for test organisms 7 4Practices for quality control of culture media. 8 4.1Documentation. 8 4.2Storage. 8 4.3Laboratory preparation of media 9 4.4Prepara
21、tion for use. 11 4.5Disposal of media. 12 5Quality control of finished product. 12 5.1Physical quality control. 12 5.2Microbiological quality control 12 Annex A (informative) Designation of the components of the culture media in standards on microbiological analysis of food and animal feeding stuffs
22、 products. 14 Annex B (informative) Guidance on preservation and maintenance of control strains 15 Annex C (informative) Quality assurance of culture media troubles-shooting 16 Bibliography. 17 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2
23、006, Uncontrolled Copy, (c) BSI Page 3 ENV ISO 11133-1:2000 Foreword The text of ENV ISO 11133-1:2000 has been prepared by Technical Committee CEN/TC 275 “Food analysis - Horizontal methods“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 34 “Agricultural f
24、ood 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 2000, and conflicting national standards shall be withdrawn at the latest by December 2000. This draft European standard “Mi
25、crobiology of food and animal feeding stuffs Guidelines on preparation and production of culture media” consists of two parts : -Part 1 : General guidelines on quality assurance for the preparation of culture media in the laboratory -Part 2 : Practical guidelines on performance testing of culture me
26、dia in the laboratory Annexes designated as “informative” are given for information only. In this standard Annexes A, B and C are informative. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stand
27、ard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Introduction In the microbiology laboratory many tests and procedures depend upon culture media bei
28、ng consistent and providing reproducible results. Culture media are used in all traditional cultural techniques and also for many alternative techniques. Many formulae of dehydrated culture media are commercially available and many more, designed for specific growth purposes, are described in the li
29、terature. Additionally, in laboratories carrying out the microbiological examination of food, the main objectives are to maintain, resuscitate, grow, detect and / or enumerate a wide variety of microorganisms. The requirements for media are specific to both the sample and the organisms to be detecte
30、d. Culture media meeting established or minimal performance criteria are therefore a pre- requisite for any reliable microbiological work. Sufficient testing should be carried out to demonstrate i) the acceptability of each batch of medium ii) that the medium is fit for purpose and iii) that the med
31、ium can produce consistent results. These three criteria are an essential part of internal quality control procedures and, with appropriate documentation, will permit effective monitoring of culture media and contribute to the production of both accurate and precise data. 1 Scope This European prest
32、andard provides the general terminology related to quality assurance of the preparation of culture media and specifies the minimum requirements to be used for the microbiological analysis of products intended for human consumption or animal feeding. These requirements are applicable to three categor
33、ies of culture media used in laboratories that prepare and/or use culture media for performing microbiological analyses : -commercially manufactured ready-to-use media ; -media prepared from commercially available dehydrated formulations (either complete e.g. plate count agar or basal media to which
34、 supplements are added e.g. Baird-Parker agar) ; -media prepared from its individual components. Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 ENV ISO 11133-1:2000 2 Normative references This European
35、Prestandard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications a
36、pply to this European Prestandard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 1659:1996, In vitro diagnostic systems Culture media for microbiology Terms and definitions. EN 12322:1999, In vitro medical d
37、evices Culture media for microbiology Performance criteria for culture media. ISO 8402:1995, Quality - Vocabulary. 3 Terminology 3.1 General This clause gives the general definitions related to quality assurance and provides different types of terminology related to culture media and to control cult
38、ures. Standards cited between brackets indicate that the text given is identical to that cited. 3.2 Terminology of quality assurance 3.2.1 quality assurance all the planned and systematic activities implemented within the quality system and demonstrated as needed, to provide adequate confidence that
39、 an entity will fulfil the requirements for quality ?ISO 8402? 3.2.2 quality control operational techniques and activities that are used to fulfil the requirements for quality ?ISO 8402? 3.2.3 internal quality control a continuous control programme of the laboratorys work prepared by or for them, an
40、d based on control analysis together with follow-up and, if necessary, corrective actions 3.2.4 batch of culture media ; lot of culture media fully traceable unit of a medium referring to a defined amount of bulk, semi-finished product or end product, which is consistent in type and quality and whic
41、h has passed the requirements of production (in-process control) and quality assurance testing, and which has been produced within one defined production period, having been assigned the same lot number ?EN 12322? 3.2.5 performance of culture media the response of a culture medium to challenge by te
42、st organisms under defined conditions Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 ENV ISO 11133-1:2000 3.3 Terminology of culture media 3.3.1 Culture medium formulation of substances, in liquid, semi
43、-solid or in solid form, which contain natural and/or synthetic constituents intended to support the multiplication, or to preserve the viability, of microorganisms NOTEWhen used in connection with compound words, this term is often shortened into “medium“ (e.g. enrichment medium). ?EN 1659? 3.3.2 C
44、ulture media classified by composition 3.3.2.1 chemically defined culture medium culture medium consisting only of chemically defined constituents (i.e. of known molecular structure and degree of purity) ?EN 1659? 3.3.2.2 chemically incomplete culture medium culture medium consisting entirely or par
45、tly of natural materials, processed or otherwise, the chemical composition of which is not completely defined NOTEFor the various chemically undefined components used in culture media, ISO/TC 34/SC 9 has specified harmonised designations - see Annex A. 3.3.3 Culture media classified by consistency 3
46、.3.3.1 liquid culture medium culture medium consisting of an aqueous solution of one or more constituents (e.g. peptone water, nutrient broth) NOTE 1In some cases, solid particles are added to the liquid culture medium. NOTE 2Liquid media in tubes, flasks or bottles are commonly called “broth“. ?EN
47、1659? 3.3.3.2 solid culture medium and semi-solid culture medium liquid culture medium containing solidifying materials (e.g. agar-agar, gelatine, etc.,) in different concentrations NOTE 1Due to the world-wide use of culture media solidified with agar-agar, the shortened term “agar“ is often used sy
48、nonymously for solid culture media and therefore in connection with nouns, e.g. “Plate count agar“. NOTE 2Solid culture media poured into Petri dishes are commonly called “plates“. Solid culture media poured into tubes that are kept in slanted positions while the media are solidifying are often call
49、ed “slants“. ?EN 1659? 3.3.4 Culture media classified by intent of use 3.3.4.1 transport medium culture medium designed to preserve and maintain the viability of microorganisms for the time period between sample collection and laboratory processing of the sample NOTETransport media usually contain substances that do not permit multiplication of microorganisms but ensure their preservation (e.g. Stuarts or Amies Transport medium). Licensed Copy: London South Bank University, London South Bank University, Sat Dec 09 04:16:36 GMT+00:00 2006, Uncontr