1、November 2016 English price group 12No 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 01.040.07; 07.100.30!%uh“258826
2、9www.din.deDIN EN ISO 16140-1Microbiology of the food chain Method validation Part 1: Vocabulary (ISO 161401:2016);English version EN ISO 161401:2016,English translation of DIN EN ISO 16140-1:2016-11Mikrobiologie der Lebensmittelkette Verfahrensvalidierung Teil 1: Terminologie (ISO 161401:2016);Engl
3、ische Fassung EN ISO 161401:2016,Englische bersetzung von DIN EN ISO 16140-1:2016-11Microbiologie de la chane alimentaire Validation des mthodes Partie 1: Vocabulaire (ISO 161401:2016);Version anglaise EN ISO 161401:2016,Traduction anglaise de DIN EN ISO 16140-1:2016-11Together with DIN EN ISO 16140
4、2:201611,supersedesDIN EN ISO 16140:201112www.beuth.deDocument comprises 21 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.16 DIN EN ISO 16140-1:2016-11 2 A comma is used as the decimal marker. National foreword This docume
5、nt (EN ISO 16140-1:2016) 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”, Working Group 6 “Microbiology of the food chain” (Secretariat: AFNOR, France). The re
6、sponsible 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 AA Validierung mikrobiologischer Verfahren. The DIN Standards corresponding to the Internat
7、ional Standards referred to in this document are as follows: ISO 3534-1 DIN ISO 3534-1 ISO 3534-2 DIN ISO 3534-2 ISO 5725 DIN ISO 5725 ISO 7218 DIN EN ISO 7218 ISO 17468 DIN EN ISO 17468 ISO 17511 DIN EN ISO 17511 Amendments This standard differs from DIN EN ISO 16140:2011-12 as follows: a) the stan
8、dard has been subdivided into several parts; b) Part 1 deals with vocabulary and Part 2 with the method validation; c) the standard has been technically revised; d) the standard has been editorially revised. Previous editions DIN EN ISO 16140: 2003-09, 2011-12 DIN EN ISO 16140-1:2016-11 3 National A
9、nnex NA (informative) Bibliography DIN ISO 3534-1:2006, Statistics Vocabulary and symbols Part 1: General statistical terms and terms used in probability (ISO 3534-1:2006) DIN ISO 3534-2:2006, Statistics Vocabulary and symbols Part 2: Applied statistics (ISO 3534-2:2006) DIN ISO 5725 (all parts), Ac
10、curacy (trueness and precision) of measurement methods and results DIN EN ISO 7218:2007, Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations (ISO 7218:2007) DIN EN ISO 17468, Microbiology of food and animal feed Technical requirements and
11、 guidance on establishment or revision of standard methods DIN EN ISO 17511:2003, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) DIN EN ISO 16140-1:2016-11 4 This p
12、age is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16140-1 July 2016 ICS 07.100.30 Supersedes EN ISO 16140:2003English Version Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016) Microbiologie de la chane alimentaire - Validatio
13、n des mthodes - Partie 1: Vocabulaire (ISO 16140-1:2016)Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 1: Terminologie(ISO16140-1:2016) This European Standard was approved by CEN on 12 May 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipu
14、late 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 Management Centre or to any CEN member. This European S
15、tandard 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 status as the official versions. CEN members are the
16、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, Malta, Netherlands, Norway, Poland, Portugal, Romania,
17、 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 All rights of exploitation in any form and by any
18、means reserved worldwide for CEN national Members. Ref. No. EN ISO 16140-1:2016 EEuropean foreword .3Introduction 51 Scope . 62 Terms and definitions . 6Bibliography . 17Contents PageForeword 4DIN EN ISO 16140-1:2016-11 EN ISO 16140-1:2016 (E) 2 European foreword This document (EN ISO 16140-1:2016)
19、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 shall be given the status of a national standard, either by publication of an i
20、dentical 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 document may be the subject of patent rights. CEN and/or CENELEC shall not be h
21、eld responsible for identifying any or all such patent rights. This document supersedes EN ISO 16140:2003. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cro
22、atia, 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, Sweden, Switzerland, Turkey and
23、the United Kingdom. Endorsement notice The text of ISO 16140-1:2016 has been approved by CEN as EN ISO 16140-1:2016 without any modification. DIN EN ISO 16140-1:2016-11 EN ISO 16140-1:2016 (E) 3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national st
24、andards 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 o
25、rganizations, 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 i
26、ts 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/d
27、irectives).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
28、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 terms and expressions rela
29、ted 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
30、.This first edition of ISO 16140-1, together with ISO 16140-2, cancels and replaces ISO 16140:2003, which has been technically revised. It also incorporates the Amendment ISO 16140:2003:Amd.1:2011.ISO 16140 consists of the following parts, under the general title Microbiology of the food chain Metho
31、d validation: Part 1: Vocabulary Part 2: Protocol for the validation of alternative (proprietary) methods against a reference methodThe following parts are under preparation: Part 3: Protocol for the verification of reference and validated alternative methods implemented in a single laboratory Part
32、4: Protocol for single-laboratory (in-house) method validation Part 5: Protocol for factorial interlaboratory validation of non-proprietary methods Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typingDIN EN ISO 16140-1:2016-11 EN ISO 16
33、140-1:2016 (E) 4 IntroductionThe use of validated methods is an important requirement for obtaining reliable results with a specific method. It also facilitates the comparability of results obtained with the same method in different laboratories. Validation procedures covered by ISO 16140 (all parts
34、) involve various aspects of validation, such as validation of alternative (proprietary) methods, single laboratory validation, validation of (alternative) methods using a limited number of laboratories, and verification of methods (demonstration of a laboratory to correctly apply a validated method
35、). In addition, there is a close link to ISO 17468 describing the procedure for the validation of the standard methods themselves.DIN EN ISO 16140-1:2016-11 EN ISO 16140-1:2016 (E) 5 1 ScopeThis part of ISO 16140 defines general terms and definitions relating to method validation of microbiology in
36、the food chain.This part of ISO 16140 is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in products intended for human consumption, products intended for animal feeding, environmental samples in the area of food and feed production, handling,
37、 and samples from the primary production stage.2 Terms and definitions2.1acceptability limitALmaximum positive or negative acceptable difference between the reference value (2.60) (or if not known, the accepted reference value) of a sample (2.69) and an individual result obtained when applying the o
38、perating procedure of an analytical methodNote 1 to entry: Because accuracy (2.2) is defined as the closeness of agreement between a measured quantity value and an assigned quantity value of a measurand, acceptability limits can be interpreted as the maximum measure of the lack of accuracy for quant
39、itative methods (2.57).2.2accuracymeasurement accuracycloseness of agreement between a measured quantity value and an assigned quantity value of a measurandNote 1 to entry: The concept measurement accuracy is not a quantity and is not given a numerical quantity value. A measurement is said to be mor
40、e accurate when it offers a smaller measurement error.Note 2 to entry: The term measurement accuracy should not be used for measurement trueness (2.77) and the term measurement precision (2.51) should not be used for measurement accuracy, which, however, is related to both these concepts.Note 3 to e
41、ntry: Measurement accuracy is sometimes understood as closeness of agreement between measured quantity values that are being attributed to the measurand.SOURCE: JCGM, 2012, modifiedDIN EN ISO 16140-1:2016-11 EN ISO 16140-1:2016 (E) 6 2.3accuracy profilegraphical representation of the capacity of mea
42、surement of the quantitative method (2.57), obtained by combining acceptability intervals and -expectation tolerance intervals (2.8), both reported to different levels of the reference value (2.60)Note 1 to entry: For a given measurement method, different accuracy profiles can be drawn, depending on
43、 the experimental design where data were collected: under repeatability conditions (2.64) or reproducibility conditions (2.67), for different matrices, etc.Note 2 to entry: Calculations of accuracy profile elements depend on experimental design.2.4alternative methodmethod submitted for validationmet
44、hod of analysis that detects or quantifies, for a given category of products, the same analyte (2.6) as is detected or quantified using the corresponding reference method (2.59)Note 1 to entry: The method can be proprietary. The term alternative is used to refer to the entire test procedure and reac
45、tion system. This term includes all ingredients, whether material or otherwise, required for implementing the method.2.5alternative method resultfinal result of the qualitative or quantitative analysis for the alternative method (2.4)2.6analytecomponent represented in the name of a measurable quanti
46、tySOURCE: ISO 17511:2003, 3.2Note 1 to entry: For food microbiology, this means a microorganism, group of microorganisms, or its products (e.g. toxins) quantified or detected by the method of analysis.Note 2 to entry: Possible targets of the techniques that are used for detection or enumeration of t
47、he analyte can be DNA/RNA, proteins, lipopolysaccharides, or others.2.7assigned valuevalue that serves as an agreed-upon reference for comparisonNote 1 to entry: It is normally derived from or based on experimental work.2.8-expectation tolerance interval-ETIrange of values within which a stated prop
48、ortion of the population is expected to lieNote 1 to entry: The stated proportion represents the probability that a value falls between an upper and lower bound of a distribution.Note 2 to entry: Tolerance intervals tend towards a fixed value as the sample (2.69) size increases.2.9biasmeasurement biasestimate of a systematic measureme
