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

ISO-16140-2 - 1ST EDITION - CURRENT


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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).

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07.100.30 (Food microbiology Including microbiology of animal feeding stuffs Animal feeding stuffs, see 65.120 General methods of tests and analysis for food products, see 67.050)

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Document Number

ISO 16140-2:2016

Revision Level

1ST EDITION

Status

Current

Publication Date

June 15, 2016

Committee Number

ISO/TC 34/SC 9