Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
ISO 16140-1:2016 defines general terms and definitions relating to method validation of microbiology in the food chain. 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.

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016)
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).

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - Amendment 1:

Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO/FDIS 16140-3:2020)
This document deals with verification of methods for the detection and/or the enumeration of microorganisms, with particular emphasis on the implementation of a reference/alternative method in the user laboratory and verification of a reference/alternative method using items included in the scope of the method and tested routinely but not tested in the original validation study

Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study. This document is applicable to single-laboratory validation of: — 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; — samples from the primary production stage; — methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G). 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. Single-laboratory validation is required if an interlaboratory validation in accordance with ISO 16140-2 is not appropriate. Possib

Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory - Amendment 1: Validation of a larger test portion size for qualitative methods (ISO 16140-4:2020/Amd 1:2024)

Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
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 gene

Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
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 production, handling; — 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; — 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

Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024)
This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used. This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from: —     products intended for human consumption; —     products for feeding animals; —     environmental samples in the area of food and feed production and handling; —     samples from the primary production stage. Identification methods only validated in accordance with this document cannot be used instead of confirmation described in: —     the reference method; —     an alternative method validated in accordance with ISO 16140-2; —     an alternative method validated in accordance with I