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 ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.It 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.It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 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 ISO 16140:2016 (all parts).
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 ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.
It 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.
It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 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 ISO 16140:2016 (all parts).
ISO 16140:2003 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuffs and environmental and veterinary samples for the validation of alternative methods which can be used in particular in the framework of the official control, and the international acceptance of the results obtained by the alternative method. It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003. Where an alternative method is used on a routine basis for internal laboratory use without the requirement to meet (higher) external criteria of quality assurance, a less stringent comparative validation of the alternative method than that set in ISO 16140:2003 may be appropriate.
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