Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
07.100.30 - Food microbiology
EN ISO 16140-6
This document specifies the general principle and the technical
protocol for the validation of alternative confirmation methods for
microbiology in the food chain. This document compares the result
of the alternative confirmation method against the confirmation
procedure of a reference method or, if needed, a reference
confirmation method (e.g. whole genome sequencing).
This document is applicable to the validation of alternative
confirmation methods used for the analysis (detection or
quantification) of isolated microorganisms in:
products intended for human consumption;
products intended for animal feeding;
environmental samples in the area of food and feed
samples from the primary production stage.
Validated alternative confirmation methods can be used to
replace (partly or completely) the confirmation procedure described
the reference method;
an alternative method validated in accordance with
ISO 16140-2 only if one of
the isolation agars specified in the validation study of the
alternative confirmation method is used.
This document is also applicable to the validation of
alternative typing methods, where the reference method can be, for
example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga
toxin-producing E. coli).
This document 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 in accordance with this document are
primarily intended to be performed by organizations or expert
laboratories involved in method validation, but can also be used by
a single laboratory, especially when performing in-house validation
under certain conditions (see ISO 16140-4).
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