BS ISO 8196-1-2009 Milk - Definition and evaluation of the overall accuracy of alternative methods of milk analysis - Analytical attributes of alternative methods《牛乳 牛乳分析变异法总准确度的定义.pdf

1、BS ISO8196-1:2009ICS 67.100.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMilk Definitionand evaluation of theoverall accuracy ofalternative methods ofmilk analysisPart 1: Analytical attributes ofalternative methodsThis British Standardwas published underthe

2、 authority of theStandards Policy andStrategy Committee on 30November 2009. BSI 2009ISBN 978 0 580 58447 3Amendments/corrigenda issued since publicationDate CommentsBS ISO 8196-1:2009National forewordThis British Standard is the UK implementation of ISO 8196-1:2009.The UK participation in its prepar

3、ation was entrusted to TechnicalCommittee AW/5, Chemical analysis of milk and milk products.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible f

4、or its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS ISO 8196-1:2009Reference numbersISO 8196-1:2009(E)IDF 128-1:2009(E)ISO and IDF 2009INTERNATIONAL STANDARD ISO8196-1IDF128-1Second edition2009-10-01Milk Definition and evaluation of the overa

5、ll accuracy of alternative methods of milk analysis Part 1: Analytical attributes of alternative methods Lait Dfinition et valuation de la prcision globale des mthodes alternatives danalyse du lait Partie 1: Attributs analytiques des mthodes alternatives BS ISO 8196-1:2009ISO 8196-1:2009(E) IDF 128-

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9、 the ISO Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO and IDF 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfil

10、m, without permission in writing from either ISO or IDF at the respective address below. ISO copyright office International Dairy Federation Case postale 56 CH-1211 Geneva 20 Diamant Building Boulevard Auguste Reyers 80 B-1030 Brussels Tel. + 41 22 749 01 11 Tel. + 32 2 733 98 88 Fax + 41 22 749 09

11、47 Fax + 32 2 733 04 13 E-mail copyrightiso.org E-mail infofil-idf.org Web www.iso.org Web www.fil-idf.org Published in Switzerland ii ISO and IDF 2009 All rights reservedBS ISO 8196-1:2009ISO 8196-1:2009(E) IDF 128-1:2009(E) ISO and IDF 2009 All rights reserved iiiContents Page Foreword iv Foreword

12、 .v Introductionvi 1 Scope1 2 Normative references1 3 Terms and definitions .1 3.1 General terms and definitions1 3.2 Terms and definitions on precision.2 3.3 Terms and definitions on accuracy .3 3.4 Other analytical characteristics .3 4 Explanation of the definitions 4 4.1 Accuracy.4 4.2 Precision.

13、5 4.3 Trueness.6 5 Assessment of precision and accuracy7 5.1 General .7 5.2 Precision: Interlaboratory trial .7 5.3 Accuracy.9 Annex A (normative) Illustration of the various criteria involved in the overall accuracy of an alternative method.12 Bibliography13 BS ISO 8196-1:2009ISO 8196-1:2009(E) IDF

14、 128-1:2009(E) iv ISO and IDF 2009 All rights reservedForeword ISO (the International 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.

15、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 with ISO, also take part in the work. ISO collaborates closely with the Internat

16、ional Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 Stand

17、ards adopted by the technical committees are circulated to the member bodies for voting. 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 subjec

18、t of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8196-1|IDF 128-1 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products, and the International Dairy Federation (IDF). It is being published joint

19、ly by ISO and IDF. This second edition of ISO 8196-1|IDF 128-1 cancels and replaces the first edition (ISO 8196-1:2000) which has been technically revised. ISO 8196|IDF 128 consists of the following parts, under the general title Milk Definition and evaluation of the overall accuracy of alternative

20、methods of milk analysis: Part 1: Analytical attributes of alternative methods Part 2: Calibration and quality control in the dairy laboratory Part 3: Protocol for the evaluation and validation of alternative quantitative methods of milk analysis BS ISO 8196-1:2009ISO 8196-1:2009(E) IDF 128-1:2009(E

21、) ISO and IDF 2009 All rights reserved vForeword IDF (the International Dairy Federation) is a non-profit organization representing the dairy sector worldwide. IDF membership comprises National Committees in every member country as well as regional dairy associations having signed a formal agreement

22、 on cooperation with IDF. All members of IDF have the right to be represented at the IDF Standing Committees carrying out the technical work. IDF collaborates with ISO in the development of standard methods of analysis and sampling for milk and milk products. The main task of Standing Committees is

23、to prepare International Standards. Draft International Standards adopted by the Action Teams and Standing Committees are circulated to the National Committees for voting. Publication as an International Standard requires approval by at least 50 % of IDF National Committees casting a vote. Attention

24、 is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IDF shall not be held responsible for identifying any or all such patent rights. ISO 8196-1|IDF 128-1 was prepared by the International Dairy Federation (IDF) and Technical Committee ISO/TC 3

25、4, Food products, Subcommittee SC 5, Milk and milk products. It is being published jointly by ISO and IDF. All work was carried out by the Joint IDF-ISO Action Team on Automated methods of the Standing Committee on Quality assurance, statistics of analytical data and sampling under the aegis of its

26、project leader, Mr. O. Leray (FR). This edition of ISO 8196-1|IDF 128-1, together with ISO 8196-2|IDF 128-2 and ISO 8196-3|IDF 128-3, cancels and replaces IDF 128:1985, which has been technically revised. ISO 8196|IDF 128 consists of the following parts, under the general title Milk Definition and e

27、valuation of the overall accuracy of alternative methods of milk analysis: Part 1: Analytical attributes of alternative methods Part 2: Calibration and quality control in the dairy laboratory Part 3: Protocol for the evaluation and validation of alternative quantitative methods of milk analysis BS I

28、SO 8196-1:2009ISO 8196-1:2009(E) IDF 128-1:2009(E) vi ISO and IDF 2009 All rights reservedIntroduction The main purpose of this part of ISO 8196|IDF 128 is to provide definitions of the relevant performance characteristics for quantitatively evaluating the overall accuracy of an analytical method, t

29、hrough the application of proper experimental designs and recommended statistical procedures. Performance characteristics of an analytical method can be defined as a set of quantitative and experimentally determined values, or criteria, of fundamental importance in assessing the suitability of a met

30、hod for any given purpose. The general concepts apply to all analytical methods, but special emphasis is given to rapid physico-chemical methods which are currently in use for compositional testing of milk. In analytical methods where measurements result from combinations of multiple output signals

31、of measurement channels either in series or in parallel (e.g. methods in which multivariate mathematical models are applied), the process of combining the primary raw information is considered as a full part of the method itself. For the purpose of ISO 8196|IDF 128 (all parts), this process is consi

32、dered as a closed device (“black box”). As such, this process is assumed to be optimized prior to the assessments and evaluations done within the scope of ISO 8196|IDF 128 (all parts). ISO 8196-2|IDF 128-2 provides practical details and recommendations for the calibration of instruments and quality

33、control in routine dairy laboratories including checking compliance with a specification value or limit. ISO 8196-3|IDF 128-3 is intended to complement this part of ISO 8196|IDF 128 as an alternative to the evaluation of new methods to which this part of ISO 8196|IDF 128 cannot apply, e.g. when the

34、organization of interlaboratory studies is hampered by the number of new instruments available, which is too small for such a protocol. While this part of ISO 8196|IDF 128 and ISO 8196-3|IDF 128-3 are mainly intended for experts to assess new methods of analysis, ISO 8196-2|IDF 128-2 aims to be a gu

35、ide for routine laboratories using these methods. ISO 8196|IDF 128 (all parts) only specifies the single linear regression model as a simplified approach to allow users to determine equivalence of an alternative method with a reference method. However, the linear regression approach is valid as a de

36、termination of method equivalence only in limited circumstances or if a high correlation between the results of the reference method and the routine method is achieved. If a high correlation is not achieved, recourse should be made to other data handling and measurement error modelling techniques. A

37、lthough these techniques are referred to, they are not specified in ISO 8196|IDF 128 (all parts). BS ISO 8196-1:2009INTERNATIONAL STANDARD ISO 8196-1:2009(E)IDF 128-1:2009(E) ISO and IDF 2009 All rights reserved 1Milk Definition and evaluation of the overall accuracy of alternative methods of milk a

38、nalysis Part 1: Analytical attributes of alternative methods 1 Scope This part of ISO 8196|IDF 128 specifies various performance characteristics that constitute and serve to characterize the overall accuracy of an analytical method. It furthermore establishes general principles for the design of exp

39、eriments and gives guidelines for the procedures to be used to evaluate these characteristics quantitatively. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references

40、, the latest edition of the referenced document (including any amendments) applies. ISO 3534 (all parts), Statistics Vocabulary and symbols ISO 5725 (all parts), Accuracy (trueness and precision) of measurement methods and results 3 Terms and definitions For the purposes of this part of ISO 8196|IDF

41、 128, the terms and definitions given in ISO 3534 (all parts) and ISO 5725-1 apply, together with the following. 3.1 General terms and definitions 3.1.1 true quantity value true value of a quantity true value quantity value consistent with the definition of a quantity NOTE 1 In the Error Approach to

42、 describing measurement, a true quantity value is considered unique and, in practice, unknowable. The Uncertainty Approach is to recognize that, owing to the inherently incomplete amount of detail in the definition of a quantity, there is not a single true quantity value but rather a set of true qua

43、ntity values consistent with the definition. However, this set of values is, in principle and in practice, unknowable. Other approaches dispense altogether with the concept of true quantity value and rely on the concept of metrological compatibility of measurement results for assessing their validit

44、y. NOTE 2 In the special case of a fundamental constant, the quantity is considered to have a single true quantity value. BS ISO 8196-1:2009ISO 8196-1:2009(E) IDF 128-1:2009(E) 2 ISO and IDF 2009 All rights reservedNOTE 3 When the definitional uncertainty associated with the measurand is considered

45、to be negligible compared to the other components of the measurement uncertainty, the measurand may be considered to have an “essentially unique” true quantity value. This is the approach taken by ISO/IEC Guide 98-3:20083and associated documents, where the word “true” is considered to be redundant.

46、ISO/IEC Guide 99:20074, 2.11 3.1.2 reference method anchor method method of analysis internationally recognized by experts or by agreement between the parties NOTE 1 Adapted from ISO 21187|IDF 196:20041, 3.2. NOTE 2 A reference method gives the “true value” or “assigned value” of the quantity of the

47、 measurand. 3.1.3 alternative method routine method method of analysis allowing quantification of the status of a test sample NOTE 1 Adapted from ISO 21187|IDF 196:20041, 3.1. NOTE 2 An alternative method demonstrates or estimates, for a given category of products, the same measurand as determined u

48、sing the corresponding reference method (3.1.2). NOTE 3 The alternative method can be either an indirect method i.e. one not measuring directly the component or the characteristic that it is intended to quantify, but instead one or more quantities or properties which are functionally linked to that

49、component or a direct method. It can have specific adaptations for user convenience (e.g. speed, automation, miniaturization, cost) that can introduce deviation into the analytical process (e.g. incomplete component or characteristic measurement) and thus prevent direct estimation and give different accuracy. 3.2 Terms and definitions on precision 3.2.1 precision closeness of agreement between independent test/measurement results obtained under stipulated conditions ISO 3534-2:2006, 3.3.4 3.2.2 repe