DIN EN ISO 16140-2:2016-11

Today, many alternative, mostly proprietary, methods exist that are used to assess the microbiological quality of raw materials and finished products and the microbiological status of manufacturing procedures. These methods are often faster and easier to perform than the corresponding standardized method. The developers, end users, and authorities need a reliable common protocol for the validation of such alternative methods. The data generated will also provide potential end users with performance data for a given method, thus, enabling them to make an informed choice on the adoption of a particular method. The data generated can also be the basis for the certification of a method by an independent organization. This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to this part of ISO 16140 are intended to be performed by organizations involved in method validation. This part of ISO 16140 is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in: - products intended for human consumption, - products intended for animal feeding, - environmental samples in the area of food and feed production, handling, and - samples from the primary production stage. This part of ISO 16140 is in particular applicable to bacteria and fungi. Some clauses of this part of ISO 16140 can be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (for example viruses and parasites) will be included in either this part or a separate part of ISO 16140. The use of this part of ISO 16140 involves expertise on relevant areas such as microbiology, statistical design, and analysis as indicated in the respective sections. The statistical expertise encompasses overview of sampling theory and design of experiments, statistical analysis of (qualitative and quantitative) microbiological data, and overview of statistical concepts on random sampling, sample heterogeneity, sample stability, design of experiments, and variance components. This document has been prepared by Technical Committee ISO/TC 34 "Food products", Subcommittee SC 9 "Microbiology" in collaboration with Technical Committee CEN/TC 275 "Food analysis - Horizontal methods", Working Group 6 "Microbiology in the food chain", the secretariat of which is held by AFNOR (France). Regarding the German collaboration Working Committee NA 057-01-12 AA "Validierung mikrobiologischer Verfahren" ("Validation of microbiological methods") is responsible at DIN Standards Committee Food and Agricultural Products (NAL).