ISO DIS 16140-6

Description / Abstract: This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, confirmation methods for microbiology in the food chain. This part of ISO 16140 compares the result of the alternative confirmation method against that of the reference confirmation procedure.

This part of ISO 16140 is applicable to the validation of alternative confirmation methods used in 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.

Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:

-the reference method; and

-an alternative method validated according to part 2 of ISO 16140 [5] as long as one of the isolation agars specified in the validation study of the alternative confirmation method is used.

This part of ISO 16140 is also applicable to the validation of alternative typing methods, where the reference method for example can be a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).

This part of ISO 16140 is in particular applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case-basis.

Validation studies according to this part of ISO 16140 are intended to be performed by organizations involved in method validation and not by single user laboratories.