DIN EN ISO 16140-6:2018-02

This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, confirmation methods in the field of microbiological analysis of food, animal feed, and environmental and primary production stage samples. This procedure is limited to the validation of alternative (proprietary) confirmation methods that are intended to replace (partly or completely) the confirmatory procedure described in the standard method for the enumeration or detection of specific (group of) microorganisms. The 'sample' to be used for confirmation shall be a suspected colony that has been obtained following the reference or alternative culture method procedure. It is however not intended for confirmation using a (pure) colony from an unknown origin. Validation studies according to this standard are intended to be performed by organizations involved in method validation.