Standard Swedish standard · SS-EN ISO 16140-2:2016/A1:2024

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 (ISO 16140-2:2016/Amd 1:2024, IDT)

Status: Valid

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Standard Swedish standard · SS-EN ISO 16140-2:2016/A1:2024

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 (ISO 16140-2:2016/Amd 1:2024, IDT)
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Scope
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).

Subjects

Food microbiology (07.100.30)


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Standard Swedish standard · SS-EN ISO 16140-2:2016/A1:2024

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 (ISO 16140-2:2016/Amd 1:2024, IDT)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

Price: 1 843,20 SEK
standard ikon pdf + standard ikon

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-82089936

Edition: 1

Approved: 9/11/2024

No of pages: 40

Amendment: SS-EN ISO 16140-2:2016