DIN EN 14793

Abstract

Scope: 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 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.