1、BRITISH STANDARD BS EN ISO 18330:2003 Incorporating Corrigendum No. 1 Milk and milk products Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues The European Standard EN ISO 18330:2003 has the status of a British Standard ICS 67.
2、100.01 BS EN ISO 18330:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 10 September 2003 BSI 27 October 2003 ISBN 0 580 42600 9 National foreword This British Standard is the official English language version of EN ISO 18330:2003. It is
3、identical with ISO 18330:2003. The UK participation in its preparation was entrusted to 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 S
4、tandards which implement international or European publications referred to in this document 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.
5、This publication does not purport to include all the necessary provisions of a contract. 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 i
6、nternational/European committee any enquiries on the interpretation, or proposals for change, 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
7、EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 12, an inside back cover 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 Comme
8、nts 14815 Corrigendum No. 1 27 October 2003 Correction to EN ISO foreword pageEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO18330 September2003 ICS67.100.01 Englishversion MilkandmilkproductsGuidelinesforthestandardized descriptionofimmunoassaysorreceptorassaysforthe detectionofantimicrobialre
9、sidues(ISO18330:2003) LaitsetproduitslaitiersLignesdirectricespourla descriptionnormalisedesessaisimmunologiquesetdes essaisrcepteurpourladtectiondesrsidus antimicrobiens(ISO18330:2003) MilchundMilchprodukteAnleitungfrdievereinheitlichte BeschreibungvonImmunoassaysoderRezeptorassays zumNachweisvonRc
10、kstndenantimikrobiellwirksamer Stoffe(ISO18330:2003) ThisEuropeanStandardwasapprovedbyCENon7August2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliograp
11、hicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheM
12、anagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPE
13、ANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO18330:2003EINESO81:033200(3E) 2 CORRECTED20031001 Foreword Th
14、isdocument(ENISO18330:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC34 “Agriculturalfoodproducts“incollaborationwithTechnicalCommitteeCEN/TC302“Milkand milkproductsMethodsofsamplingandanalysis“,thesecretariatofwhichisheldbyNEN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypub
15、licationof anidenticaltextorbyendorsement,atthelatestbyMarch2004,andconflictingnational standardsshallbewithdrawnatthelatestbyMarch2004. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech
16、 Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerlandand theUnitedKingdom. Endorsementnotice ThetextofISO18330:2003hasbeenapprovedbyCENasENISO18330:2003withoutany modifications. ENISO18330:2003 Re
17、ference numbers ISO 18330:2003(E) IDF 188:2003(E)INTERNATIONAL STANDARD ISO 18330 IDF 188 First edition 2003-09-01 Milk and milk products Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues Laits et produits laitiers Lignes direc
18、trices pour la description normalise des essais immunologiques et des essais rcepteur pour la dtection des rsidus antimicrobiens ENISO18330:2003IS:03381 O3002(E) ID:881 F3002(E) DPlcsid Fremia ihTs PDF file mya ctnoian emdebt dedyfepcaes. In ccacnadrow eitA hebods licnesilop gnic,y tihs file mirp eb
19、 yatnde iv roweb detu slahl ton ide ebtlnu deess teh typfecaes wihce era hml era deddebicsnede ti dna onstlalde t noeh comuptfrep reromign tide ehtin.g In wodlnidaot gnihs fil,e raptitpecca se tierehn ter ehssnopiiblito yf ton ifnirigngn Aebods licnesign lopic.y ieNtt reheh ISeC Otnrla eScretarain t
20、or hte DIa Fccepts any ailbytili ni htsi area. Ai ebods a tedarmfo kra Aebod SystemI snctaropro.de teDials fo teh sfotwcudorp erats sut deo crtaee tihs PDF file cna f ebi dnuon tlareneG eh Ifnler oatit evt oeh file; tP ehDc-Frtaeino marapteres wtpo ereimizf dero irptni.gn Evyre cneeb sah era tkane t
21、o sneeru ttah teh file is siutlbae fsu roe yb ISO memdob rebeis dna IDF antilano ocmmittees. In the unlikely veent that a problem relating to it is f,dnuo lpsaei efnmro tI ehStneC Olar Scerteirata ta teh serddas igleb nevow. ISO dna ID3002 F All irthgs erse.devr lnUeto sswrehise specified, on trap f
22、o this lbupictaion maeb y cudorperro de tuilizi den yna form ro na ybm ynae,s lecetrinoc ro mceinahcla, incliduntohp gcoiypodna gn micrfoilm, wittuoh repmissii now nritign from eitI rehSro O IDF ta ter ehstcepiev serddas lebwo. ISO cirypothg fofice Itntanreilano iaDtaredeF yrino saCe tsopale 65 eneG
23、 1121-HC 02 av Dimanat Builid gn BoulA draveugust 08 sreyeR e B 0301-Bssurels 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-ifd. groii ENISO18330:2003 iiiForeword ISO (the International
24、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 interested in a subject for which a technical committee has been esta
25、blished 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 standardiza
26、tion. 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 votin
27、g. 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
28、patent rights. ISO 18330IDF 188 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 is being published jointly by ISO and IDF and separately by AOAC Interna
29、tional. ENISO18330:2003iv Foreword IDF (the International Dairy Federation) is a worldwide federation of the dairy sector with a National Committee in every member country. Every National Committee has the right to be represented on the IDF Standing Committees carrying out the technical work. IDF co
30、llaborates with ISO and AOAC International in the development of standard methods of analysis and sampling for milk and milk products. Draft International Standards adopted by the Action Teams and Standing Committees are circulated to the National Committees for voting. Publication as an Internation
31、al Standard requires approval by at least 50 % of the National Committees casting a vote. ISO 18830IDF 188 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.
32、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 Analytical methods for additives and contaminants, under the aegis of its
33、project leader, Mr E. Mrtlbauer (DE) ENISO18330:2003 vIntroduction Because of the method of detection, the tests described in this International Standard may have limitations so that they cannot be used for quantification. For example, receptor assays have group-specific detection and not chemical-s
34、pecific detection. Consequently, positive results cannot be subject to quantitation without knowledge of the identity of the specific contaminant. Moreover, assays based on a visual evaluation of colour development may not measure the degree of colour and thus may not provide a quantitative value. W
35、ithin an integrated system for antimicrobial residue detection, immunoassays and receptor assays may be used as primary-screening methods (e.g. for screening of compounds which can not be detected at regulatory levels by microbiological inhibition assays). These methods may also be used as post-scre
36、ening methods for preliminary identification and quantification of compounds in samples with a positive result in a microbiological inhibition assay. Depending on whether a certain test complies with the specifications given, immunoassays and receptor assays may be used for routine quality control,
37、especially if the absence/presence of a certain compound in concentrations exceeding a certain level e.g. maximum residue limit (MRL) has to be determined. Substances which are not approved or for which no MRLs have been fixed, may require specific consideration. For legal purposes in many countries
38、, positive results obtained by immunoassays or receptor assays require confirmation by an accepted physico-chemical method. ENISO18330:2003 1Milk and milk products Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues 1 Scope This
39、International Standard gives guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues in milk and milk products. It is intended to provide a framework and basis for the evaluation/validation of tests based on the binding of an antimic
40、robial compound to its specific antibody or to other types of detecting molecules. In addition to immunoassays e.g. enzyme-immunoassay (EIA) and radio-immunoassay (RIA), there are several quantitative, semi-quantitative and qualitative test formats based on the binding of antimicrobial compounds to
41、microbial receptors or to receptor proteins. Enzymatic assays and particle-based assays based on receptor proteins are referred to as receptor assays in this International Standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For
42、dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 13969, Milk and milk products Guidance for a standardized description of microbial inhibitor tests 3 Terms and definitions For the purposes
43、of this document, the following terms and definitions apply. 3.1 false positives percentage of positive results when testing negative samples 3.2 false negatives percentage of negative results at the claimed detection level(s) 3.3 specificity extent to which the presence of substances with chemical
44、structures similar to that of the target analyte will result in a positive result (cross-reaction) 3.4 limit of detection for qualitative tests concentration level at which a defined percentage of samples is detected, e.g. 95 % together with the respective confidence level. ENISO18330:20032 3.5 limi
45、t of detection for quantitative tests concentration level which gives a final result that is statistically different from that of negative milk 4 Information needed from the developer/manufacturer 4.1 Methodology The developer or manufacturer of the test should provide information regarding methodol
46、ogy by mentioning the following: a) description of the method (e.g. sample preparation and test performance); b) principle of the method (e.g. competitive direct enzyme-immunoassay); c) evaluation of test results (e.g. visual or instrumental reading, criteria for positive or negative result); d) cap
47、acity (e.g. sample throughput); e) special requirements for sampling, preservation and testing; f) procedure for the purpose of quality assurance, including the use of positive/negative control samples; g) field of application concerning the intended test use e.g. screening for milk quality payment
48、or for regulatory purposes (detection of banned substances), the substrate or matrix (e.g. raw tanker bulk milk or heat-treated milk), and the limitations with respect to sample composition (e.g. cell count and bacteriological quality). 4.2 Test kit reagents The following information should be given regarding test kit reagents. a) In the case of immunoassays: 1) ty
