Mikrobiologi

Ämnesområden: Livsmedelsmikrobiologi
Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: CEN
Svarsdatum: den 28 feb 2018
Se merSe mindre
 

This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, confirmation methods for microbiology in the food chain. This part of ISO 16140 compares the result of the alternative confirmation method against that of the reference confirmation procedure.

This part of ISO 16140 is applicable to the validation of alternative confirmation 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, and

- 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; and

- an alternative method validated according to part 2 of ISO 16140 [5] as long as one of the isolation agars specified in the validation study of the alternative confirmation method is used.

This part of ISO 16140 is also applicable to the validation of alternative typing methods, where the reference method for example can be a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).

This part of ISO 16140 is in particular applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case-basis.

Validation studies according to this part of ISO 16140 are intended to be performed by organizations involved in method validation and not by single user laboratories.

Ämnesområden: Livsmedelsmikrobiologi
Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: CEN
Svarsdatum: den 28 feb 2018
Se merSe mindre
 

This part of ISO 16140 describes the protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this part of ISO 16140 only validate the method for the laboratory conducting the study.

This part of ISO 16140 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, and

- samples from the primary production stage.

This part of ISO 16140 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 according to ISO 16140-2 is not appropriate, e.g. for in-house methods. Possible applications are:

- validation of new in-house method;

- the first step in the validation process according to ISO 17468[2];

- extension of the scope of an ISO 16140-2 validated method: e.g. category extension or test portion size;

- modifications of existing methods.

Within ISO 17468[2], single-laboratory validation is the first step in the standardization of a method. It can be applied only for methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and which have already been optimised.

Ämnesområden: Livsmedelsmikrobiologi
Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: CEN
Svarsdatum: den 28 feb 2018
Se merSe mindre
 

This part of ISO 16140 describes the protocol for the verification of reference methods, standardized reference methods and validated alternative methods for implementation in the user laboratory. Method verification does not apply to non-validated alternative methods.

This part of ISO 16140 is applicable to the verification of methods used for the analysis (detection and/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 can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.

The verification focuses on those (food) items that are within the scope of validation and are tested in the user laboratory.

Ämnesområden: Livsmedelsmikrobiologi
Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: CEN
Svarsdatum: den 28 feb 2018
Se merSe mindre
 

This part of ISO 16140 describes the general principle and the technical protocol (based on orthogonal, factorial studies) for the validation of non-proprietary methods for microbiology of the food chain.

This part of ISO 16140 is applicable to the validation of non-proprietary 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, and

- samples from the primary production stage.

This part of ISO 16140 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 part of ISO 16140 only applies 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 which have already been optimised.