Standard

ISO 16140-2:2016

Jun 2016 Current

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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 method comparison study data evaluation, relative level of detection calculations in the interlaboratory study, calculation and interpretation of the relative trueness study, and inclusion of a commercial sterility testing protocol for specific products Withdrawn draft ISO 16140-2:2016/Amd 1:2024 Amendment from Publication date: Sep 2024 Pages: 25 Language: English, French Services: Online, Online + Pdf
Open product
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 method comparison study data evaluation, relative level of detection calculations in the interlaboratory study, calculation and interpretation of the relative trueness study, and inclusion of a commercial sterility testing protocol for specific products Withdrawn draft ISO 16140-2:2016/Amd 1:2024 Amendment from Publication date: Sep 2024 Pages: 27 Language: English, French Services: Online, Online + Pdf
Open product
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 method comparison study data evaluation, relative level of detection calculations in the interlaboratory study, calculation and interpretation of the relative trueness study, and inclusion of a commercial sterility testing protocol for specific products Current ISO 16140-2:2016/Amd 1:2024 Amendment from Publication date: Sep 2024 Pages: 26 Language: English, French Services: Online, Online + Pdf

Abstract

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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Standard from ISO
Published: June 17 2016
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 07.100.30
International TC: ISO/TC 34/SC 9

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Adopted by: SN EN ISO 16140-2:2016
Adopted by: NF EN ISO 16140-2:2016
Revises: ISO 16140:2003

ISO 16140-2:2016

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ISO 16140-2:2016

ISO 16140:2003/Amd 1:2011

ISO 16140:2003

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Version history Related Corrigenda and Amendments (3)

ISO 16140-2:2016/Amd 1:2024

ISO 16140-2:2016/Amd 1:2024

ISO 16140-2:2016/Amd 1:2024

Version history History (3)

ISO 16140-2:2016

ISO 16140:2003/Amd 1:2011

ISO 16140:2003

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