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DIN EN 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 16140-2:2016)

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Organization: DIN
Publication Date: 1 November 2016
Status: active
Page Count: 75
ICS Code (Food microbiology): 07.100.30
scope:

This part of ISO 16140 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 this part of ISO 16140 are intended to be performed by organizations involved in method validation.

This part of ISO 16140 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.

This part of ISO 16140 is in particular applicable to bacteria and fungi. Some clauses of this part of ISO 16140 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 either this part or a separate part of ISO 16140.

Document History

August 1, 2023
Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - AMENDMENT 1: Revision of qualitative MCS data evaluation, RLOD calculations in the ILS, calculation and interpretation of the RT study, and inclusion of a commercial sterility testing protocol for specific products (ISO 16140-2:2016/DAM 1:2023); German and English version EN ISO 16140-2:2016/prA1:2023
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DIN EN ISO 16140-2
November 1, 2016
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)
This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies...

References

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