BS EN ISO 16140-1-2016 Microbiology of the food chain Method validation Vocabulary《食品链微生物学 方法验证 词汇》.pdf

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1、BS EN ISO 16140-1:2016Microbiology of the food chain Method validationPart 1: Vocabulary (ISO 16140-1:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 16140-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO

2、16140-1:2016. Together with BS EN ISO 16140-2:2016, it supersedes BS EN ISO 16140:2003+A1:2011 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee AW/9, Microbiology.A list of organizations represented on this committee can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 secr

3、etary.This publication does not purport to include 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 69939 9ICS 07.100.30Compliance with a British Standard cannot c

4、onfer immunity fromlegal obligations.This British 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 16140-1 July 2

5、016 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 - Validation des mthodes - Partie 1: Vocabulaire (ISO 16140-1:2016)Mikrobiologie der Lebensmittelkette - Verf

6、ahrensvalidierung - Teil 1: Terminologie (ISO 16140-1:2016) This European Standard was approved by CEN on 12 May 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without

7、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 exists in three official versions (English, French, German). A version in any other lang

8、uage 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 standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmar

9、k, 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 andUnited Kingdom. EUROPEAN COMMITTEE FO

10、R 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 reserved worldwide for CEN national Members. Ref. No. EN ISO 16140-1:2016 EBS EN ISO 16140

11、-1:2016EN ISO 16140-1:2016 (E) 3 European foreword This document (EN ISO 16140-1:2016) 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 S

12、tandard 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 January 2017. Attention is drawn to the possibility that some of the elements

13、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. This document supersedes EN ISO 16140:2003. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following c

14、ountries 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, Luxembourg, Malta, Netherlands, Norway,

15、 Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and 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. BS EN ISO 16140-1:2016ISO 16140-1:2016(E)Foreword ivIntroduction v1 Sco

16、pe . 12 Terms and definitions . 1Bibliography .12 ISO 2016 All rights reserved iiiContents PageBS EN ISO 16140-1:2016ISO 16140-1:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing I

17、nternational 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 organizations, governmental and non-governmental, in liaison

18、 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 its further maintenance are described in the ISO/IEC Directi

19、ves, 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/directives).Attention is drawn to the possibility that some

20、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 the Introduction and/or on the ISO list of patent declarati

21、ons 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 related to conformity assessment, as well as information about

22、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.This first edition of ISO 16140-1, together with ISO 16140

23、-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 Method validation: Part 1: Vocabulary Part 2: Protocol for the v

24、alidation 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 4: Protocol for single-laboratory (in-house) method validat

25、ion 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 typingiv ISO 2016 All rights reservedBS EN ISO 16140-1:2016ISO 16140-1:2016(E)IntroductionThe use of

26、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) involve various aspects of validation,

27、 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). In addition, there is a close link to

28、 ISO 17468 describing the procedure for the validation of the standard methods themselves. ISO 2016 All rights reserved vBS EN ISO 16140-1:2016BS EN ISO 16140-1:2016Microbiology of the food chain Method validation Part 1: Vocabulary1 ScopeThis part of ISO 16140 defines general terms and definitions

29、relating to method validation of microbiology in 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 i

30、n the area of food and feed production, handling, 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

31、an individual result obtained when applying the operating 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

32、maximum measure of the lack of accuracy for quantitative 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 numerica

33、l quantity value. A measurement is said to be more 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, howev

34、er, is related to both these concepts.Note 3 to entry: Measurement accuracy is sometimes understood as closeness of agreement between measured quantity values that are being attributed to the measurand.SOURCE: JCGM, 2012, modifiedINTERNATIONAL STANDARD ISO 16140-1:2016(E) ISO 2016 All rights reserve

35、d 1BS EN ISO 16140-1:2016ISO 16140-1:2016(E)2.3accuracy profilegraphical representation of the capacity of measurement 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

36、 (2.60)Note 1 to entry: For a given measurement method, different accuracy profiles can be drawn, depending on 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 a

37、ccuracy profile elements depend on experimental design.2.4alternative methodmethod submitted for validationmethod 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 ent

38、ry: The method can be proprietary. The term alternative is used to refer to the entire test procedure and reaction system. This term includes all ingredients, whether material or otherwise, required for implementing the method.2.5alternative method resultfinal result of the qualitative or quantitati

39、ve analysis for the alternative method (2.4)2.6analytecomponent represented in the name of a measurable quantitySOURCE: 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 o

40、f analysis.Note 2 to entry: Possible targets of the techniques that are used for detection or enumeration of the 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

41、or based on experimental work.2.8-expectation tolerance interval-ETIrange of values within which a stated proportion 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 e

42、ntry: Tolerance intervals tend towards a fixed value as the sample (2.69) size increases.2.9biasmeasurement biasestimate of a systematic measurement error, or the systematic difference between the quantitative assigned value (2.7) and the average of measurement replicate (2.65) results2 ISO 2016 All

43、 rights reservedBS EN ISO 16140-1:2016ISO 16140-1:2016(E)2.10blind replicatesset of samples (2.69) submitted to evaluate performance in which the presence and/or concentration of the analyte (2.6) is unknown to the analystNote 1 to entry: Within validation (2.81) studies, blind replicates (2.10) are

44、 used within the interlaboratory study (2.33). The organizing laboratory (2.45) prepares samples (2.69) and sends them to the collaborators (2.13). These samples are labelled (marked) in such a way that the collaborator (2.13) does not know if they contain the analyte (2.6), or not.2.11categorygroup

45、 of sample (2.69) types (2.78) of the same originEXAMPLE Heat-processed milk and dairy products.2.12certified reference materialCRMreference material (2.58) characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of

46、 the specified property, its associated uncertainty, and a statement of metrological traceabilityNote 1 to entry: Adapted from ISO Guide 30 and ISO Guide 35.2.13collaboratorindividual laboratory technician, who works completely independently from other collaborators, using different sets of blind sa

47、mples (2.69) or test portions (2.75)2.14combined standard deviationcombined standard uncertaintystandard measurement uncertainty that is obtained using the individual standard uncertainties associated with the input quantities in a measurement modelSOURCE: JCGM, 2012, modified2.15confidence interval

48、value (1 ) of the probability associated with a confidence interval or a statistical coverage intervalEXAMPLE Confidence intervals can be obtained for arithmetic means, standard deviations, regression coefficients, etc.Note 1 to entry: (1 ) is often expressed as a percentage.2.16confidence levelspec

49、ific probability of obtaining some result from a sample (2.69) if it did not exist in the population as a wholeNote 1 to entry: The usual levels of probability are 95 % or 99 %, but any level can be used.2.17confirmation procedure or testprocedure or test which is carried out to verify a presumptive resultNote 1 to entry: Not all methods have a confirmation procedure. ISO 2016 All rights reserved 3BS EN ISO 16140-1:2016ISO 16140-1:2016(E)2.18countobserved number of objectsEXAMPLE Colonies or plaques.2.19coverage f