1、November 2016 English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 07.100.30!%ui“2588270www.din.de
2、DIN EN ISO 17468Microbiology of the food chain Technical requirements and guidance on establishment or revision of a standardized reference method (ISO 17468:2016);English version EN ISO 17468:2016,English translation of DIN EN ISO 17468:2016-11Mikrobiologie der Lebensmittelkette Technische Anforder
3、ungen und Leitfaden zur Einfhrung oder berarbeitung eines genormten Referenzverfahrens (ISO 17468:2016);Englische Fassung EN ISO 17468:2016,Englische bersetzung von DIN EN ISO 17468:2016-11Microbiologie de la chane alimentaire Exigences et recommandations techniques pour le dveloppement ou la rvisio
4、n dune mthode de rfrence normalise (ISO 17468:2016);Version anglaise EN ISO 17468:2016,Traduction anglaise de DIN EN ISO 17468:2016-11www.beuth.deDocument comprises 12 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.16 DIN E
5、N ISO 17468:2016-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17468:2016) has been prepared by Technical Committee ISO/TC 34 “Food products”, Subcommittee SC 9 “Microbiology” in collaboration with Technical Committee CEN/TC 275 “Food analysis Horizontal methods
6、”, Working Group WG 6 “Microbiology of the food chain” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Committee NA 057-01-12
7、AA Validierung mikrobiologischer Verfahren. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 16140-1 DIN EN ISO 16140-1 ISO 16140-2 DIN EN ISO 16140-2 National Annex NA (informative) Bibliography DIN EN ISO 16140-1, Microbiology of food
8、and animal feed Method validation Part 1: Vocabulary DIN EN ISO 16140-2, Microbiology of food and animal feed Method validation Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17468 July 2016
9、 ICS 07.100.30 English Version Microbiology of the 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
10、 mthode de rfrence normalise (ISO 17468:2016) Mikrobiologie der Lebensmittelkette - Technische Anforderungen und Leitfaden zur Einfhrung oder berarbeitung eines genormten Referenzverfahrens(ISO 17468:2016) This European Standard was approved by CEN on 20 June 2015. CEN members are bound to comply wi
11、th the CEN/CENELEC Internal Regulations which stipulate the 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 Mana
12、gement Centre or to any CEN member. This European Standard exists 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 st
13、atus as the official versions. CEN members are the national 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, Mal
14、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, 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
15、 All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17468:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Technical procedure for standardizing a new reference method . 74.1 Gene
16、ral . 74.2 Technical steps 74.2.1 Step 1: Method(s) selection 74.2.2 Step 2: Method(s) evaluation study . 74.2.3 Step 3: “Real life”/multilaboratory study . 84.2.4 Step 4: Selection of method for further validation . 84.2.5 Step 5: Interlaboratory study 85 Technical procedure for revising a standard
17、ized reference method 95.1 General . 95.2 Impact of reference method revision on the existing validation of alternative methods . 9Annex A (normative) Flow chart on technical steps for the establishment or revision of a standardized reference method 10Contents PageDIN EN ISO 17468:2016-11 EN ISO 174
18、68:2016 (E)2Foreword .4European 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 - Horizontal methods” the secretariat of which is held by DIN. This European Standard shal
19、l 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 January 2017. Attention is drawn to the possibility that some of the elements of this docu
20、ment 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 standards organizations of the following countries are bound to implement this European Standard:
21、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, Slovenia, Spain, S
22、weden, 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. DIN EN ISO 17468:2016-11 EN ISO 17468:2016 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide fed
23、eration 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 established has the right to be represented on that comm
24、ittee. 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 standardization.The procedures used to develop this document an
25、d those intended for its 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, Par
26、t 2 (see www.iso.org/directives).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 th
27、e document will be in the 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 term
28、s and expressions related 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, Subcommit
29、tee SC 9, Microbiology.DIN EN ISO 17468:2016-11 EN ISO 17468:2016 (E)4 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, Microb
30、iology, 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/acc
31、eptability values. These values are not set in the present edition of this International Standard, due to the lack of available data.DIN EN ISO 17468:2016-11 EN ISO 17468:2016 (E)5 1 ScopeThis International Standard gives technical requirements and guidance on the establishment or revision of standa
32、rdized reference methods for the analysis (detection or quantification) of microorganisms in products intended for human consumption and for the feeding of animals, environmental samples in the area of food/feed production and food/feed handling, and samples from the primary production stage.This In
33、ternational Standard defines the technical stage (or early stage) of the establishment of a new standardized reference method or of the revision of an existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method.This Internati
34、onal 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 Horizontal methods, Working Group 6, Microbiology of the food chain.2 Normative referencesThe following documents, in whole or in part, are normatively
35、referenced in this document and are indispensable to its application For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 16140-1, Microbiology of the food chain Method validation Part 1: Vo
36、cabularyISO 16140-2:2016, Microbiology of the food chain Method validation Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 16140-1 and the following app
37、ly.3.1candidate reference methodmethod selected and likely to become the standardized reference method (3.5)3.2multilaboratory studystudy of one or several methods conducted in different laboratories, using their own samples analysed in routine3.3prestandardization stagetechnical stage prior to stan
38、dardization stage and comprising different steps described in this International StandardNote 1 to entry: Standardization stage starts with voting on a New Work Item Proposal for inclusion of the Work Item in the work programme.DIN EN ISO 17468:2016-11 EN ISO 17468:2016 (E)6 3.4“real life” studystud
39、y of one or several methods, using a wide range of samples and with preference given to naturally 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 standardiz
40、ing a new reference method4.1 GeneralIn the frame of this International Standard, five technical 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”/mult
41、ilaboratory study; step 4: selection of the proposed reference method for further validation; 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 standardizat
42、ion process.A flow chart on the technical steps for the establishment of a new standardized 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 evaluatio
43、n data, evaluation/validation reports on methods, practicability of the method) shall be made 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.
44、2 Step 2: Method(s) evaluation studyAn evaluation study of the candidate reference method(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
45、scope of the method applicability to the range of food categories or environmental sample 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
46、in ISO 16140-2:2016, 5.1.3.1). For each food category/sample type, at least one food type 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
47、of the method.DIN EN ISO 17468:2016-11 EN ISO 17468:2016 (E)7 This evaluation 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,
48、inclusivity and exclusivity (in accordance with ISO 16140-2:2016, 5.1); 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 alterna
