DIN EN ISO 22118:2011-11

Molecular detection methods have been developed during the last few decades, and are now available for the majority of food-borne pathogens. Some of these methods have the potential for quantitative analysis. Although until now most methods are based on Polymerase Chain Reaction (PCR) and real-time PCR, other molecular detection and quantification principles should be kept under consideration. To compare molecular methods with conventional methods or with other principles, it is necessary to generate minimum requirements for performance characteristics of the methods to be developed. This International Standard DIN EN ISO 22118 specifies minimum requirements of performance characteristics for the detection of nucleic acid sequences (DNA or RNA) by molecular (detection) methods. This International Standard applies to the detection of food-borne pathogens in foodstuffs and isolates obtained from them using molecular detection methods based on the polymerase chain reaction (PCR). This standard can be used in all fields of foodstuff production and monitoring. This standard deals in particular with product safety and health-related consumer protection. The committee responsible for this standard is NA 057-01-06-01 AK "Polymerase-Kettenreaktion zum Nachweis von Mikroorganismen" ("Polymerase chain reaction for the detection of microorganisms") at DIN.