BS EN ISO 16140-2:2016 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 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in either this part or a separate part of ISO 16140.


Cross References:
ISO 16140-1
ISO 5725-2
ISO 11133
ISO 16297
ISO/TS 22117
79/373/EEC


Together with BS EN ISO 16140-1:2016, it supersedes BS EN ISO 16140:2003+A1:2011 which is withdrawn

All current amendments available at time of purchase are included with the purchase of this document.