1、BS EN 14793:2017Stationary source emissions Demonstration of equivalenceof an alternative method witha reference methodBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 14793:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of
2、EN 14793:2017.It supersedes DD CEN/TS 14793:2005 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee EH/2/1, Stationary source emission.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does
3、not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 85048 6 ICS 13.040.40 Compliance with a British Standard cannot confer immunity from lega
4、l obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 14793:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14793 January 2017 IC
5、S 13.040.40 Supersedes CEN/TS 14793:2005English Version Stationary source emissions - Demonstration of equivalence of an alternative method with a reference method missions de sources fixes - Dmonstration de lquivalence dune mthode alternative avec une mthode de rfrence Emissionen aus stationren Que
6、llen - Nachweis der Gleichwertigkeit eines Alternativverfahrens mit einem Referenzverfahren This European Standard was approved by CEN on 26 September 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
7、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 exists in three official versions (English, French
8、, 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 standards bodies of Austria, Belgium, Bulgaria, C
9、roatia, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, T
10、urkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members
11、. Ref. No. EN 14793:2017 EBS EN 14793:2017EN 14793:2017 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 6 4 Symbols . 9 5 Contents of the demonstration of equivalence 11 5.1 General . 11 5.2 Description of the alternative method .
12、 11 5.3 Determination of performance characteristics 12 5.3.1 General . 12 5.3.2 Manual method . 12 5.3.3 Automatic method . 13 5.4 Calculation of the expanded uncertainty of the AM . 13 5.5 Demonstration of equivalence in the field 14 5.5.1 Coverage of in field demonstration . 14 5.5.2 Evaluation o
13、f repeatability and trueness in relation to the RM 15 6 Report of the demonstration of equivalence . 18 Annex A (informative) Example of comparison of repeatability and trueness of Thorin Method and Ion Chromatography Method for SO2measurement in stack 21 Annex B (informative) Critical values for Gr
14、ubbs test 32 Annex C (normative) Minimum requirements for a test bench 33 Bibliography . 34 BS EN 14793:2017EN 14793:2017 (E) 3 European foreword This document (EN 14793:2017) has been prepared by Technical Committee CEN/TC 264 “Air quality”, the secretariat of which is held by DIN. This document su
15、persedes CEN/TS 14793:2005. 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 July 2017, and conflicting national standards shall be withdrawn at the latest by July 2017. Attention is drawn to the p
16、ossibility 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 standards organizations of the following countrie
17、s 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, Poland
18、, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 14793:2017EN 14793:2017 (E) 4 Introduction Much has been published in the literature concerning method validation by collaborative study. CEN/TC 264 working groups try to follow these me
19、thod validations when a new standard is prepared and the collaborative study is probably the preferred way of carrying out the validation. However, it is not always a suitable option for accredited laboratories. The application for which the method is required can be esoteric to the extent that no o
20、ther laboratories would be interested in collaboration. Those that might be interested can be competitors. This European Standard provides one of possible methods of testing the equivalence of an alternative method (AM) with the standard reference method (SRM) or with a reference method (RM) if the
21、legislator has not defined a standard reference method. NOTE The term “reference method” is used in this standard to cover reference methods as well as standard reference methods. In the framework of certification of automated measuring systems used for the measurement of stationary source emissions
22、 this European Standard can be used in conjunction with EN 15267-4:2017 to demonstrate the equivalence of portable automated measuring systems (P-AMS) based on an AM with the standard reference method (SRM). BS EN 14793:2017EN 14793:2017 (E) 5 1 Scope This European Standard specifies a procedure to
23、demonstrate the equivalence of an alternative method (AM) with the reference method (RM) or the standard reference method (SRM), both implemented to determine the same measurand. In particular, this European Standard provides the statistical tools and different criteria to evaluate the alternative m
24、ethod. This does not release the body performing the equivalence testing from bearing technical and analytical judgement on the evaluation of the different criteria. Three steps are required for demonstration of equivalence: description of the alternative method and setting of the field of applicati
25、on (measurement range and type of gas matrix); determination of the performance characteristics of the alternative method and calculation of the expanded uncertainty where appropriate and check of compliance with the maximum expanded uncertainty allowed for the reference method; check of repeatabili
26、ty and lack of systematic deviation of the alternative method in the field or on a recognized test bench in comparison with the reference method for the type of matrix defined in the field of equivalence. This European Standard requires that a reference method has been defined and validated. This Eu
27、ropean Standard only considers the case of linear quantitative methods. This European Standard is applicable to manual and automated methods. This European Standard has been drawn up for laboratories working in air quality measurements and consequently an example taken from this sector are presented
28、 in Annex A. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includ
29、ing any amendments) applies. EN ISO 14956, Air quality - Evaluation of the suitability of a measurement procedure by comparison with a required measurement uncertainty (ISO 14956) ISO 5725-1:1994, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and def
30、initions ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method ISO/IEC Guide 98-3:2008, Uncertainty of measurement Part 3: Guide to the expression of uncertaint
31、y in measurement (GUM:1995) BS EN 14793:2017EN 14793:2017 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 standard reference method SRM reference method prescribed by European or national legislation SOURCE: EN 15259:2007 Note 1 to entr
32、y: Standard reference methods are used e.g. to calibrate and validate automated measuring systems permanently installed at stacks and for periodic measurements to check compliance with limit values. 3.2 reference method RM measurement method taken as a reference by convention, which gives the accept
33、ed reference value of the measurand Note 1 to entry: A reference method is fully described. Note 2 to entry: A reference method can be a manual or an automated method. Note 3 to entry: Alternative methods can be used if equivalence to the reference method has been demonstrated. SOURCE: EN 15259:2007
34、 3.3 alternative method AM measurement method which complies with the criteria given by this European Standard with respect to the reference method Note 1 to entry: An alternative method can consist of a simplification of the reference method. 3.4 measurement method method described in a written pro
35、cedure containing all the means and procedures required to sample and analyse, namely field of application, principle and/or reactions, definitions, equipment, procedures, presentation of results, other requirements and measurement report 3.5 calibration set of operations that establish, under speci
36、fied conditions, the relationship between values of quantities indicated by a measuring method or measuring system, and the corresponding values given by the applicable reference 3.6 accepted reference value value which serves as a reference value (or conventionally true value) of the sample, provid
37、ed by the reference method or standard reference method BS EN 14793:2017EN 14793:2017 (E) 7 3.7 demonstration of equivalence act of subjecting a measurement method to a study, which is based on a standardised and/or recognised protocol and which provides proof that, for its field of application, the
38、 measurement method satisfies pre-established performance criteria Note 1 to entry: In the framework of this European Standard, the demonstration of equivalence of a method is mainly based on an “in field” study that includes comparison to a reference method. 3.8 field of application combination of
39、the different types of matrix and the range of concentrations of the measured component covered, to which the measurement method is applied Note 1 to entry: As well as being an indication of all the satisfactory performance conditions for each factor, the field of application of the measurement meth
40、od can also include warnings concerning known interferences caused by other components, or the inapplicability of certain matrices or conditions. 3.9 matrix all the components of the sample other than the measured component Note 1 to entry: Some components of the matrix can influence the result of m
41、easurement. These components are called interferents. 3.10 measurand particular quantity subject to measurement SOURCE: EN 15259:2007 Note 1 to entry: The measurand is a quantifiable property of the stack gas under test, for example mass concentration of a measured component, temperature, velocity,
42、mass flow, oxygen content and water vapour content. 3.11 measured component constituent of the waste gas for which a defined measurand is to be determined by measurement SOURCE: EN 15259:2007 Note 1 to entry: Measured component is also called determinand. 3.12 reference material substance or mixture
43、 of substances, with a known concentration within specified limits, or a device of known characteristics BS EN 14793:2017EN 14793:2017 (E) 8 3.13 linearity capacity of a measurement method, within certain limits, to provide an instrument response or results proportional to the quantity of the measur
44、and to be determined in the sample Note 1 to entry: This proportionality is expressed through a defined a priori mathematical expression. Note 2 to entry: The linearity limits are the concentration limits in the experiment between which a linear calibration model can be applied with a known level of
45、 confidence. 3.14 lack of fit systematic deviation, within the measurement range, between the accepted value of a reference material applied to the measuring system and the corresponding result of measurement produced by the calibrated measuring system Note 1 to entry: In common language lack of fit
46、 is often called “linearity” or “deviation from linearity”. Lack of fit test is often called “linearity test”. 3.15 detection limit LDsmallest quantity of the measurand which can be detected, but not quantified, in the experiment conditions described for the measurement method 3.16 quantification li
47、mit LQsmallest quantity of the measurand which can be quantified, in the experiment conditions described for the measurement method 3.17 repeatability closeness of agreement between independent test results obtained under stipulated conditions Note 1 to entry: Repeatability depends exclusively upon
48、the distribution of random errors and has no relation with the true or specified value. Note 2 to entry: The measure of repeatability is calculated from the standard deviation of test results. A lower level of repeatability is reflected by a greater standard deviation. Note 3 to entry: The term “ind
49、ependent test results” signifies results obtained in such a way as not to be influenced by a previous result on the same or similar testing equipment. Quantitative measurements of repeatability depend critically upon the stipulated conditions. Repeatability and reproducibility conditions are specific groups of extreme conditions. 3.18 trueness closeness of agreement between the average value obtained from a large series of test results and an accepted reference value SOURCE: ISO 5725-1:1994 Note 1 to entry: The measure of trueness is generally e
