This document specifies the general principles and the technical protocols (based on orthogonal, factorial studies) for the validation of non-proprietary methods for microbiology of the food chain.
This document is applicable to the validation of methods used 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;
— samples from the primary production stage.
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.
This document specifies protocols for the validation against a reference method for both quantitative and qualitative methods. This document also provides a protocol for the validation of quantitative methods without a reference method. Qualitative methods cannot be validated without a reference method in accordance with this document.
NOTE ISO 16140-2 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods against a reference method.
This document is only applicable to the validation of methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.
Methods that have been validated in accordance with this document can be used by the laboratories of the specified population of laboratories.