EN 14793:2017

Stationary source emissions - Demonstration of equivalence of an alternative method with a reference method

This European Standard specifies a procedure to 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 method. 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 application (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 repeatability 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 European Standard only considers the case of linear quantitative 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 in Annex A.

Emissionen aus stationären Quellen - Nachweis der Gleichwertigkeit eines Alternativverfahrens mit einem Referenzverfahren

Diese Europäische Norm legt ein Verfahren zum Nachweis der Gleichwertigkeit eines Alternativverfahrens (AM) mit dem Referenzverfahren (RM) oder dem Standardreferenzverfahren (SRM) fest, wobei beide zur Bestimmung derselben Messgröße eingesetzt werden.
Diese Europäische Norm enthält insbesondere die statistischen Methoden und verschiedene Kriterien zur Bewertung des Alternativverfahrens. Das entbindet aber nicht die für den Nachweis der Gleichwertigkeit zuständige Stelle von der Aufgabe, die Auswertung der verschiedenen Kriterien technisch und analytisch zu beurteilen.
Der Nachweis der Gleichwertigkeit beinhaltet drei Schritte:
   Beschreibung des Alternativverfahrens und Festlegung des Anwendungsbereichs (Messbereich und Art der Abgasmatrix);
   Bestimmung der Verfahrenskenngrößen des Alternativverfahrens und gegebenenfalls Berechnung der erweiterten Unsicherheit sowie Überprüfung der Einhaltung der maximal zulässigen erweiterten Unsicherheit für das Referenzverfahren;
   Überprüfung der Wiederholpräzision und des Fehlens systematischer Abweichungen des Alternativverfahrens beim Einsatz im Feld oder an einem anerkannten Prüfstand durch Vergleich mit dem Referenzverfahren für die Art der Abgasmatrix, die im Äquivalenzbereich festgelegt ist.
Diese Europäische Norm setzt voraus, dass das Referenzverfahren eindeutig festgelegt und validiert wurde.
Diese Europäische Norm ist nur bei linearen quantitativen Verfahren anwendbar.
Diese Europäische Norm ist auf manuelle und automatische Verfahren anwendbar.
Diese Europäische Norm wurde für Laboratorien erstellt, die Messungen im Bereich der Luftreinhaltung durchführen. Anhang A zeigt deshalb ein entsprechendes Beispiel aus diesem Bereich.

Émissions de sources fixes - Démonstration de l'équivalence d'une méthode alternative avec une méthode de référence

Emisije nepremičnih virov - Dokazovanje enakovrednosti alternativne metode z referenčno metodo

Ta evropski standard določa postopek za dokazovanje enakovrednosti alternativne metode z referenčno metodo ali standardno referenčno metodo (SRM), pri čemer sta obe uporabljeni za določanje istih merjenih veličin.
Ta evropski standard podaja predvsem statistična orodja in različna merila za ovrednotenje alternativne metode. S tem organ za izvajanje enakovrednega preskušanja ni oproščen tehnične in analitične presoje pri ocenjevanju različnih meril.
Za prikaz enakovrednosti so zahtevani trije koraki:
opis alternativne metode in določitev področja uporabe (merilno območje in vrsta plinske matrike);
določitev lastnosti zmogljivosti alternativne metode in izračun razširjene negotovosti, kjer je to ustrezno, ter preverjanje skladnosti pri največji razširjeni negotovosti, ki je dovoljena za referenčno metodo;
preverjanje ponovljivosti in pomanjkanje sistematičnega odstopanja alternativne metode na terenu ali v priznanem preskusnem okolju v primerjavi z referenčno metodo za vrsto matrike, opredeljeno za enakovredno področje.
Ta evropski standard zahteva opredelitev in potrditev referenčne metode.
Ta evropski standard zajema samo linearne kvantitativne metode.
Ta evropski standard je bil pripravljen za laboratorije, ki izvajajo meritve kakovosti zraka, zato je primer za ta sektor na voljo v dodatku A.

General Information

• Status: Published
• Publication Date: 10-Jan-2017
• Withdrawal Date: 30-Jul-2017
• ICS: 13.040.40 - Stationary source emissions
• Technical Committee: CEN/TC 264 - Air quality
• Drafting Committee: CEN/TC 264 - Air quality
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 15-Sep-2022
• Completion Date: 14-Apr-2025
• Ref Project: SIST EN 14793:2017 - Stationary source emissions - Demonstration of equivalence of an alternative method with a reference method

Relations

• Replaces: CEN/TS 14793:2005 - Stationary source emission - Intralaboratory validation procedure for an alternative method compared to a reference method
• Effective Date: 18-Jan-2017

Overview - EN 14793:2017 (CEN)

EN 14793:2017 specifies a standardized procedure to demonstrate the equivalence of an alternative method (AM) with a reference method (RM) or a standard reference method (SRM) for measuring the same measurand in stationary source emissions. Published by CEN and intended for air quality and emissions measurements, the standard focuses on linear quantitative methods (both manual and automated) and supplies the statistical tools and criteria needed to evaluate an AM against an established RM.

Key topics and technical requirements

• Three-step equivalence demonstration
  • Describe the AM and define its field of application (measurement range and gas matrix/type of sample).
  • Determine performance characteristics of the AM and calculate the expanded uncertainty, including checking compliance with the RM’s maximum allowed uncertainty.
  • Verify repeatability and absence of systematic deviation (trueness) by comparing AM and RM results in the field or on a recognized test bench.
• Statistical tools and tests
  • Use of repeatability, variance, bias/trueness evaluation and regression comparisons to assess agreement with the RM.
  • Outlier tests and lack-of-fit/linearity checks for linear quantitative methods.
• Reporting and documentation
  • Comprehensive report including method description, field of application, uncertainty budget, test design, statistical analysis and conclusions.
• Scope limits and responsibilities
  • Applicable only where a validated RM/SRM exists.
  • The standard provides statistical criteria but requires the assessing body to exercise technical and analytical judgement.
• Supporting material in the standard
  • Annex A: practical example from air quality (SO2 comparison).
  • Annex C: minimum test bench requirements.

Practical applications and users

• Who uses EN 14793:2017
  • Accredited testing laboratories and conformity assessment bodies.
  • Environmental regulators and agencies assessing alternative measurement methods for emissions compliance.
  • Instrument manufacturers and developers validating alternative analytical methods or portable automated measuring systems (P-AMS) (in conjunction with EN 15267-4:2017).
  • Consultants and QA/QC specialists preparing equivalence dossiers.
• Why it’s useful
  • Enables method substitution where appropriate, permitting simpler or automated AMs while ensuring measurement quality and legal defensibility.
  • Supports method validation workflows for stack gas monitoring, multi-component analysers (e.g., FTIR), and periodic compliance testing.

Related standards (normative/informative)

• EN ISO 14956 - suitability vs. required uncertainty
• ISO 5725-1 / ISO 5725-2 - accuracy, repeatability and reproducibility principles
• ISO/IEC Guide 98-3 (GUM) - expression of measurement uncertainty
• EN 15267-4:2017 - certification framework for automated measuring systems

Keywords: EN 14793:2017, alternative method equivalence, stationary source emissions, reference method, expanded uncertainty, repeatability, trueness, air quality measurements, CEN.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Emissionen aus stationären Quellen - Nachweis der Gleichwertigkeit eines Alternativverfahrens mit einem ReferenzverfahrenÉmissions de sources fixes - Démonstration de l'équivalence d'une méthode 'alternative' avec une méthode de référenceStationary source emissions - Demonstration of equivalence of an alternative method with a reference method13.040.40Stationary source emissionsICS:Ta slovenski standard je istoveten z:EN 14793:2017SIST EN 14793:2017en,fr,de01-julij-2017SIST EN 14793:2017SLOVENSKI
STANDARDSIST-TS CEN/TS 14793:20051DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14793
January
t r s y English Version
Stationary source emissions æ Demonstration of equivalence of an alternative method with a reference method Émissions de sources fixes æ Démonstration de l 5équivalence d 5une méthode alternative avec une méthode de référence
Emissionen aus stationären Quellen æ Nachweis der Gleichwertigkeit eines Alternativverfahrens mit einem Referenzverfahren This European Standard was approved by CEN on
t x September
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s v y { uã t r s y ESIST EN 14793:2017

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 . 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 of 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 SO2 measurement in stack . 21 Annex B (informative)
Critical values for Grubbs test . 32 Annex C (normative)
Minimum requirements for a test bench . 33 Bibliography . 34
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 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).
In particular, this European Standard provides the statistical tools and different criteria to evaluate the alternative method. 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 application (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 repeatability 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 European 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 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 (including 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 definitions 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 uncertainty in measurement (GUM:1995) SIST EN 14793:2017

SRM reference method prescribed by European or national legislation
[SOURCE: EN 15259:2007] Note 1 to entry: 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 accepted 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] 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 procedure 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 specified 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, provided by the reference method or standard reference method
combination of 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 method 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 measurement. 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, 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 of substances, with a known concentration within specified limits, or a device of known characteristics SIST EN 14793:2017

Table 1 — Symbols and formulae Symbol Description Formula
0C intercept of the orthogonal regression line between AM and RM values ()()0sxCxzsz=−
1C slope of the orthogonal regression line between AM and RM values ()()1sxCsz=
dix difference between 1ix and 2ix for each value of i ()12diiixxx=−
ie ratio between dix and ix for each value of i diiixex=
e average value of the values ie 1niieen==∑
iG ratio between ()iee− and ()ise ()iiieeGse−=
DL detection limit
QL quantification limit
p number of trials
in number of parallel measurement for the AM and for the RM for a trial i
N total number of measurements for the AM and for the RM 1piiNn==∑ r correlation coefficient SPD(,)SSD()SSD()xzrxz=×
()ise standard deviation of the population of the ie ()()2111niiiseeen==−−∑
()2sx variance of the AM
()()2SSD1xsxp=−
()rsx repeatability standard deviation of the AM
()2rsx repeatability variance of the AM ()()2112ipnijiijrxxsxNp==−=−∑∑.
()2sz variance of the RM ()()2SSD1zszp=−
()rsz repeatability standard deviation of the RM
()2rsz repeatability variance of the RM
()()2112ipnijiijrzzszNp==−=−∑∑
(),limitrsz maximum allowable repeatability standard deviation for the RM
()Rsz reproducibility standard deviation given in the RM standard
()SPD,xz sum of the products of the deviations for two variables x and z
()()()1SPD,piiixzxxzz==−×−∑
()SSDx sum of the squares of the mean deviations for the AM
()()21SSDpiixxx==−∑
()SSDz sum of the squares of the mean deviations for the RM ()()21SSDpiizzz==−∑.
RMU maximum permissible expanded uncertainty given in the RM standard
ijx concentration obtained by the AM for a trial i and repetition j
ix arithmetic mean of ijx for which in measurements have been taken 1inijjiixxn==∑
x grand average of ijx for which N measurements have been taken 11ipnijijxxN===∑∑
px outlier
ijz concentration obtained by the RM for a trial i and repetition j
iz arithmetic mean of ijz for which in measurements have been taken 1inijjiizzn==∑ SIST EN 14793:2017

z grand average of ijz for which N measurements have been taken 11injpijizzN===∑∑
qz outlier
5 Contents of the demonstration of equivalence
5.1 General The demonstration of equivalence shall include the following items: — description of the alternative method (see 5.2); — determination of performance characteristics (see 5.3); — calculation of the expanded uncertainty of the alternative method (see 5.4); — demonstration of equivalence in the field (see 5.5). WARNING 1
The field of application of an alternative method can partially or completely cover the field of application of the reference method. However, if it covers the fields of application of several reference methods (horizontal method), several evaluations of each reference method shall be performed, e.g. in the case of multi-component measurement methods like FTIR. WARNING 2
The definition of the field of application depends entirely upon the laboratory applying the alternative method and the knowledge acquired during the development of the method. It is sometimes preferable to segment a field of application rather than to attempt to validate an overly general method. In this case, a validation file for each field of application shall be compiled. 5.2 Description of the alternative method The description shall permit all competent persons to use it (including the procedure and the calculations). The following items should be addressed: — title; — warnings and safety precautions (where relevant); — introduction; — purpose and field of application; — standard references; — definitions; — principle (sampling and analysis); — reagents and products (where relevant); — equipment (e.g.: description of the sampling line and measuring device); — procedures for quality checks; — definition of performance characteristics and determination procedures; SIST EN 14793:2017

— response time; — limit of detection and quantification; — lack of fit; — drift on a duration adapted to the measurement purpose; — repeatability; — dependence on sampling gas pressure; — dependence on ambient temperature; — dependence on voltage; — interferences; — leakage of the sampling line; — absorption in the sampling system; — adjustment of the analyser; — reference material (e.g. calibration gas). 5.4 Calculation of the expanded uncertainty of the AM The expanded uncertainty of the AM shall be calculated by building an uncertainty budget according to EN ISO 14956 or ISO/IEC Guide 98-3 (GUM). The maximum expanded uncertainty of the alternative method shall be compared with the reference’s and shall be lower or equal to the maximum expanded uncertainty specified by the reference method at the emission limit value. SIST EN 14793:2017

5.5.1 Coverage of in field demonstration 5.5.1.1 General The demonstration of equivalence in the field shall be performed at suitable plant(s). If necessary, a combination of two sets of data drawn from trials performed on plant(s) and on a test bench recognized by the competent authorities and meeting the requirements in Annex C may be used.
5.5.1.2 Gas matrixes The “in field demonstration” covers the field of application of the method defined under the sole responsibility of the test laboratory. In practice, it is the responsibility of the laboratory to demonstrate that the field of application of the method is correctly covered, in terms of types of matrixes. The laboratory may determine the effect of each of the individual compounds present in the flue gases suspected to have
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