Microbiologia lanţului alimentar. Validarea metodelor. Partea 1: Vocabular
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.

Microbiologia lanţului alimentar. Validarea metodelor. Partea 2: Protocol pentru validarea metodelor alternative (supuse dreptului de proprietate) în raport cu o metodă de referinţă
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).

Microbiologia lanţului alimentar. Validarea metodelor. Partea 2: Protocol pentru validarea metodelor alternative (supuse dreptului de proprietate) în raport cu o metodă de referinţă. Amendament 1: Revizuirea evaluării datelor din studiile de comparare a metodelor calitative, a calculului nivelului de detecție din studiul interlaboratoare și a interpretării studiului de corectitudine relativă, precum și adăugarea unui protocol pentru determinarea sterilității comerciale pentru produse specifice

Microbiologia lanțului alimentar. Validarea metodelor. Partea 3: Protocol pentru verificarea într-un singur laborator a metodelor de referință și a metodelor alternative validate
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

Microbiologia lanțului alimentar. Validarea metodelor. Partea 3: Protocol pentru verificarea într-un singur laborator a metodelor de referință şi a metodelor alternative validate. Amendament 1: Protocol pentru verificarea metodelor validate de identificare a microorganismelor

Microbiologia lanţului alimentar. Validarea metodelor. Partea 4: Protocol pentru validarea metodei într-un singur laborator
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

Microbiologia lanţului alimentar. Validarea metodelor. Partea 4: Protocol pentru validarea metodei într-un singur laborator. Amendamentul 1: Validarea unei porțiuni de testare mai mari pentru metodele calitative

Microbiologia lanţului alimentar. Validarea metodelor. Partea 4: Protocol pentru validarea metodelor într-un singur laborator. Amendament 2: Protocol pentru validarea într-un singur laborator a metodelor de identificare a microorganismelor

Microbiologia lanţului alimentar. Validarea metodelor. Partea 5: Protocol pentru validarea interlaboratoare a metodelor nesupuse dreptului de proprietate prin plan cu factori
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