DIN EN ISO 16140:2011-12

The need for the food industry to rapidly assess the microbiological quality of raw materials and finished products and the microbiological status of manufacturing procedures has led to the development and refinement of alternative microbiological methods of analysis that are quicker and/or easier to perform than the corresponding reference methods; some can also be automated. Among these alternative methods, some can yield results that are equivalent to those provided by the reference method, while others can lead to results that differ appreciably. The suppliers/producers of the alternative methods, the food and drink industry, the public health services and other authorities need a reliable common protocol for the validation of such alternative methods. The data generated can also be the basis for the certification of a method by an independent organisation. Because of the extent of the methods comparative study described in this standard for use by the organising laboratory, the procedure is sometimes not appropriate for use as an "in house" method for the validation of an alternative method by an individual laboratory. This document establishes the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuff and environmental and veterinary samples for the following: - the validation of alternative methods which can be used in particular in the framework of the official control of foodstuffs; - the international acceptance of the results obtained by the alternative method. It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in this standard EN ISO 16140. With respect to DIN EN ISO 16140:2003-09, subclause 6.3 "Interlaboratory study" and Annex Q "Calculation of Rousseeuw's scale estimator Q_n" have been fundamentally revised. Furthermore, Annex V "Indicators for Mandel's robust h- and k-statistics" and Annex W "Example: Determination of E. coli" have been added and the Bibliography has been updated. The committee responsible for this standard is NA 057-01-12 AA "Validierung mikrobiologischer Verfahren" ("Validation of microbiological methods") at DIN.