1、BS EN ISO 17468:2016Microbiology of the food chain Technical requirements andguidance on establishmentor revision of a standardizedreference method (ISO17468:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 17468:2016 BRITISH STANDARDNational forewordTh
2、is British Standard is the UK implementation of EN ISO17468:2016.The UK participation in its preparation was entrusted to TechnicalCommittee AW/9, Microbiology.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to includ
3、e all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 80476 2ICS 07.100.30Compliance with a British Standard cannot confer immunity fromlegal obligations.This British
4、 Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17468 July 2016 ICS 07.100.30 English Version Microbiology of t
5、he food chain - Technical requirements and guidance on establishment or revision of a standardized reference method (ISO 17468:2016) Microbiologie de la chane alimentaire - Exigences et recommandations techniques pour le dveloppement ou la rvision dune mthode de rfrence normalise (ISO 17468:2016) Mi
6、krobiologie der Lebensmittelkette - Technische Anforderungen und Leitfaden zur Einfhrung oder berarbeitung von Standardverfahren (ISO 17468:2016) This European Standard was approved by CEN on 20 June 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
7、conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard e
8、xists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national
9、standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia
10、, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means res
11、erved worldwide for CEN national Members. Ref. No. EN ISO 17468:2016 EBS EN ISO 17468:2016EN ISO 17468:2016 (E) 3 European foreword This document (EN ISO 17468:2016) has been prepared by Technical Committee ISO/TC 34 “Food products“ in collaboration with Technical Committee CEN/TC 275 “Food analysis
12、 - 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 identical text or by endorsement, at the latest by January 2017, and conflicting national standards shall be withdrawn at the latest by
13、 January 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standar
14、ds organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxe
15、mbourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17468:2016 has been approved by CEN as EN ISO 17468:2016 without any modification. BS EN ISO 17468:2016ISO 17468:2016(E)For
16、eword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Technical procedure for standardizing a new reference method . 24.1 General . 24.2 Technical steps 24.2.1 Step 1: Method(s) selection 24.2.2 Step 2: Method(s) evaluation study . 24.2.3 Step 3: “Real life”/multilabo
17、ratory study . 34.2.4 Step 4: Selection of method for further validation . 34.2.5 Step 5: Interlaboratory study 35 Technical procedure for revising a standardized reference method 45.1 General . 45.2 Impact of reference method revision on the existing validation of alternative methods . 4Annex A (no
18、rmative) Flow chart on technical steps for the establishment or revision of a standardized reference method . 5 ISO 2016 All rights reserved iiiContents PageBS EN ISO 17468:2016ISO 17468:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national sta
19、ndards 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 established has the right to be represented on that committee. International or
20、ganizations, 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 standardization.The procedures used to develop this document and those intended for it
21、s further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/di
22、rectives).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 patent rights. Details of any patent rights identified during the development of the document will be in t
23、he Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions relat
24、ed to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 34, Food products, Subcommittee SC 9, Microbiology.
25、iv ISO 2016 All rights reservedBS EN ISO 17468:2016ISO 17468:2016(E)IntroductionThis International Standard has been developed in order to set common rules for the validation of reference methods standardized in the field of food microbiology by ISO/TC 34, Food products, Subcommittee SC 9, Microbiol
26、ogy, and its corresponding structure at CEN level (CEN/TC 275, Food analysis Horizontal methods, Working Group 6, Microbiology of the food chain).This International Standard refers to the complete process of method validation, including comparison of performance data to predetermined criteria/accept
27、ability values. These values are not set in the present edition of this International Standard, due to the lack of available data. ISO 2016 All rights reserved vBS EN ISO 17468:2016BS EN ISO 17468:2016Microbiology of the food chain Technical requirements and guidance on establishment or revision of
28、a standardized reference method1 ScopeThis International Standard gives technical requirements and guidance on the establishment or revision of standardized reference methods for the analysis (detection or quantification) of microorganisms in products intended for human consumption and for the feedi
29、ng of animals, environmental samples in the area of food/feed production and food/feed handling, and samples from the primary production stage.This International Standard defines the technical stage (or early stage) of the establishment of a new standardized reference method or of the revision of an
30、 existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method.This International Standard is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding structure at CEN level, CEN/TC 275, Food analysis Ho
31、rizontal methods, Working Group 6, Microbiology of the food chain.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable to its application For dated references, only the edition cited applies. For undated references, the
32、 latest edition of the referenced document (including any amendments) applies.ISO 16140-1, Microbiology of the food chain Method validation Part 1: VocabularyISO 16140-2:2016, Microbiology of the food chain Method validation Part 2: Protocol for the validation of alternative (proprietary) methods ag
33、ainst a reference method3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 16140-1 and the following apply.3.1candidate reference methodmethod selected and likely to become the standardized reference method (3.5)3.2multilaboratory studystudy of one or se
34、veral methods conducted in different laboratories, using their own samples analysed in routine3.3prestandardization stagetechnical stage prior to standardization stage and comprising different steps described in this International StandardNote 1 to entry: Standardization stage starts with voting on
35、a New Work Item Proposal for inclusion of the Work Item in the work programme.INTERNATIONAL STANDARD ISO 17468:2016(E) ISO 2016 All rights reserved 1BS EN ISO 17468:2016ISO 17468:2016(E)3.4“real life” studystudy of one or several methods, using a wide range of samples and with preference given to na
36、turally contaminated samples3.5standardized reference methodreference method described in a standardNote 1 to entry: See ISO 16140-1 for the definition of “reference method”.4 Technical procedure for standardizing a new reference method4.1 GeneralIn the frame of this International Standard, five tec
37、hnical steps (see 4.2) are required for the validation of a method in view of its standardization as a reference method: step 1: method(s) selection; step 2: method(s) evaluation study; step 3: “real life”/multilaboratory study; step 4: selection of the proposed reference method for further validati
38、on; step 5: interlaboratory study.Except for step 5 in certain cases (see 4.2.5), these five technical steps correspond to a prestandardization stage (see 3.3), being performed before launching the standardization process.A flow chart on the technical steps for the establishment of a new standardize
39、d reference method is given in Annex A.4.2 Technical steps4.2.1 Step 1: Method(s) selectionInformation from different sources (national/regional standardized methods, scientific papers on methods with evaluation data, evaluation/validation reports on methods, practicability of the method) shall be m
40、ade available for the choice of a candidate reference method (see 3.1). Based on the information available, the group in charge of developing the standard selects one or several candidate reference methods.4.2.2 Step 2: Method(s) evaluation studyAn evaluation study of the candidate reference method(
41、s) (see 4.2.1) is conducted, normally by one laboratory, but more than one laboratory may also be involved.The evaluation of the candidate reference method/each candidate reference method aims at assessing the scope of the method applicability to the range of food categories or environmental sample
42、type to which the method applies. If the method is to be applied to a broad range of foods (general case for standardized reference methods), then at least five categories of food shall be studied (see details in ISO 16140-2:2016, 5.1.3.1). For each food category/sample type, at least one food type
43、and one suitable strain shall be selected. This evaluation study should be conducted in artificial contamination conditions, in order that step 2 and step 3 (see 4.2.3) are complementary to assessing the scope of the method.2 ISO 2016 All rights reservedBS EN ISO 17468:2016ISO 17468:2016(E)This eval
44、uation study should also enable estimation of performance parameters and fulfil the requirements of the method comparison study, as stated in ISO 16140-2: for qualitative methods: sensitivity and specificity, level of detection, inclusivity and exclusivity (in accordance with ISO 16140-2:2016, 5.1);
45、 for quantitative methods: relative trueness (see next paragraph), accuracy profile, inclusivity and exclusivity, and optionally, limit of quantification (in accordance with ISO 16140-2:2016, 6.1).ISO 16140-2:2016, 5.1 and 6.1 describe a method validation study, comparing an alternative method to a
46、reference method. The methodology described in these subclauses may be used to compare the different candidate reference methods. If one candidate reference method has been selected (see 4.2.1), these subclauses need to be adapted to the case of validating a method alone, without comparison to anoth
47、er method. In particular, reference materials or artificially contaminated samples may be used instead of the reference method to assess the sensitivity and specificity/trueness of the candidate reference method.NOTE For further details on the procedure for preparing samples, see of ISO 16140-2:2016
48、, Annex C.If several candidate reference methods have been evaluated at this step, the outcome of this evaluation study should enable the relevant group in charge of developing the standard to reduce the number of candidate reference methods.4.2.3 Step 3: “Real life”/multilaboratory studyThe “real l
49、ife” study (see 3.4) shall be conducted on the candidate reference method(s) (see 4.2.1), using a wide range of samples with preference given to naturally contaminated samples. This study is a multilaboratory study (see 3.2) conducted in different laboratories, preferably located in different countries/different parts of the world to cover the largest diversity possible of:a) matrices where the target microorganism can naturally be found;b) strains of the target microorganism.In particular, each laboratory shall use its own reag
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