EN ISO 13969-2004 en Milk and milk products - Guidelines for a standardized description of microbial inhibitor tests《奶和奶制品 微生物抑制剂试验的标准化描述指南 ISO 13969-2003》.pdf

1、BRITISH STANDARD BS EN ISO 13969:2004 Milk and milk products Guidelines for a standardized description of microbial inhibitor tests The European Standard EN ISO 13969:2004 has the status of a British Standard ICS 07.100.30 BS EN ISO 13969:2004 This British Standard was published under the authority

2、of the Standards Policy and Strategy Committee on 25 August 2004 BSI 25 August 2004 ISBN 0 580 44339 6 National foreword This British Standard is the official English language version of EN ISO 13969:2004. It is identical with ISO 13969:2003. The UK participation in its preparation was entrusted to

3、Technical Committee AW/5, Milk and milk products, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this docu

4、ment may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract.

5、 Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for ch

6、ange, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank

7、page, pages 1 to 13 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO13969 August2004 ICS07.100.30 Englishversion Milkandmil

8、kproductsGuidelinesforastandardized descriptionofmicrobialinhibitortests(ISO13969:2003) LaitetproduitslaitiersLignesdirectricespourune descriptionnormalisedesmthodesmicrobiologiquesde dpistagedinhibiteursmicrobiens(ISO13969:2003) MilchundMilchprodukteAnleitungfreinevereinheitlichte Beschreibungmikro

9、biologischerHemmstofftests(ISO 13969:2003) ThisEuropeanStandardwasapprovedbyCENon1October2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalrefe

10、rencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralS

11、ecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain

12、,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO13969:2004:E I NES

13、O 31:9692004 (E) 2 Foreword The text of ISO 13969:2003 has been prepared by Technical Committee ISO/TC 34 “Agricultural food products“ of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13969:2004 by Technical Committee CEN/TC 302 “Milk and milk products -

14、Methods of sampling and analysis“, the secretariat of which is held by NEN. 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 2005, and conflicting national standards shall be withdrawn at

15、the latest by February 2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Icelan

16、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 13969:2003 has been approved by CEN as EN ISO 13969:2004 without any modifications. ENISO13969:2004 Re

17、ference numbers ISO 13969:2003(E) IDF 183:2003(E) OSI DI dnaF 3002INTERNATIONAL STANDARD ISO 13969 IDF 183 First edition 2003-10-01 Milk and milk products Guidelines for a standardized description of microbial inhibitor tests Lait et produits laitiers Lignes directrices pour une description normalis

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23、B-1 030Brssuels leT. 14 + 20 947 2111 eTl. 23 + 29 337 888 aFx0 947 22 14 + 974 aFx0 337 2 23 + 431 -Email copyrightisoo.rg -Emailni off-lidif.org We bwww.is.o gro We bwww.fil-idf.o gr Plbuisdehi n Switlrez dnaii ISO dnaID 3002 FA ll rihgtsser edevrENISO13969:2004IS:96931 O3002(E) ID:381 F3002(E) I

24、SO dna ID 3002 F All irhgts seredevr iiiForeword 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 bo

25、dy interested 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 Electrot

26、echnical 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 b

27、y the technical 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 ri

28、ghts. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13969IDF 183 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products, and the International Dairy Federation (IDF), in collaboration with AOAC International. It

29、is being published jointly by ISO and IDF and separately by AOAC International. ENISO13969:2004IS:96931 O3002(E) ID:381 F3002(E) iv I SO dna ID 3002 F All irhgts seredevrForeword IDF (the International Dairy Federation) is a worldwide federation of the dairy sector with a National Committee in every

30、 member country. Every National Committee has the right to be represented on the IDF Standing Committees carrying out the technical work. IDF collaborates with ISO and AOAC International in the development of standard methods of analysis and sampling for milk and milk products. Draft International S

31、tandards adopted by the Action Teams and Standing Committees are circulated to the National Committees for voting. Publication as an International Standard requires approval by at least 50 % of IDF National Committees casting a vote. Attention is drawn to the possibility that some of the elements of

32、 this International Standard may be the subject of patent rights. IDF shall not be held responsible for identifying any or all such patent rights. ISO 13969IDF 183 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products, and the International Dairy Fed

33、eration (IDF), in collaboration with AOAC International. It is being published jointly by ISO and IDF and separately by AOAC International. All work was carried out by the Joint ISO/IDF/AOAC Action Team Antimicrobials and other veterinary medical residues, of the Standing Committee on Analytical met

34、hods for additives and contaminants, under the aegis of its project leader, Mrs G. Suhren (DE). ENISO13969:2004IS:96931 O3002(E) ID:381 F3002(E) I SO dna ID 3002 F All irhgts seredevr vIntroduction The parameters outlined in this International Standard may not need to be evaluated completely for eve

35、ry test, depending on a) the field of application of the test under study (e.g. screening or reference method, type of milk, i.e. animal species or raw/heat treated milk), b) the information needed e.g. the introduction of a new substance with fixed maximum residue limit (MRL), and c) the detection

36、pattern (e.g. sensitivity of the test microorganism to a broad or narrow variety of antimicrobial compounds). Thus “the terms of reference” between the producer and user of a certain test should be agreed upon in the context of these guidelines omitting, for example, those aspects that are not relev

37、ant to the intended field of application. A general disadvantage related to the interpretation of microbial inhibitor tests is that they are usually evaluated in a subjective way and in very few steps, i.e. negative, questionable, and positive by comparison with positive and/or negative control samp

38、les. In cases where the medium contains an indicator, the type of the resultant colour change can depend upon the type of antimicrobial present. This sometimes makes it difficult to obtain a clear distinction between positive and negative results. Test interpretation in few steps also means that sma

39、ll alterations or minor colour developments, which may be of importance in a validation programme, need major experimental effort. ENISO13969:20044002:96931OSINENITERNATNOIAL STANDARD IS:96931 O3002(E) ID:381 F002(3)EI SO dna ID 3002 F All irhgts seredevr 1Milk and milk products Guidelines for a sta

40、ndardized description of microbial inhibitor tests 1 Scope This International Standard gives guidance for a standardized description of microbial inhibitor tests for milk and milk products. It is intended to give a framework and basis for the evaluation/validation of microbial inhibitor tests, allow

41、ing the comparison of data obtained from different tests and experimental studies. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 false positives percentage of positive results when testing negative samples 2.2 false negatives percentage of

42、negative results at the claimed detection level(s) 2.3 limit of detection concentration level at which a defined percentage of samples is detected EXAMPLE 95 % together with the respective confidence level. 3 Information needed from the developer/manufacturer 3.1 Methodology The developer or manufac

43、turer of the test should provide information regarding methodology by mentioning the following: a) description of the method; b) principle of the method; c) technical design of the procedure (e.g. degree of automation, data processing); d) evaluation of test results (e.g. scores, scale and definitio

44、n of what to consider “positive” or “negative”); e) capacity (e.g. sample throughput); f) special requirements for sampling, preservation and testing; ENISO13969:2004IS:96931 O3002(E) ID:381 F3002(E) 2 I SO dna ID 3002 F All irhgts seredevrg) procedure for the purpose of quality assurance by the dev

45、eloper/manufacturer; h) field of application concerning 1) the intended test use (e.g. screening or confirmation), and 2) the substrate or matrix (e.g. milk from cows or other animals, milk powder or other foods). 3.2 Operating requirements The following information should be given regarding operati

46、ng requirements: a) requirements for user experience and training; b) requirements for safety and special laboratory service (e.g. electric power, S1-lab, waste disposal and maximum concentration level); c) requirements for quality control by the manufacturer and/or user. 3.3 Test specifications The

47、 following information should be given regarding test definitions: limit of detection: see 2.3. 3.4 Documentation The following information should be given regarding documentation: a) user manual, including a trouble-shooting guide; b) suppliers of instruments, reagents, standards, technical service

48、s and customer support; c) status of official recognition/general introduction in specified countries; d) availability of reference material; e) availability of internationally recognized/validated reference from ISO, IDF and AOAC International, or others; f) availability of, for example, literature and practical experiences. 4 Evaluation of the attributes of the microbiological inhibitor test 4.1 General The validation of a method should always be carried out under controlled conditions, i.e. based on defined t