Reference number
ISO 16140-2:2016
© ISO 2025
International Standard
ISO 16140-2:2016
Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
Edition 1
2016-06
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Published (Edition 1, 2016)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.
This standard has 1 amendment.

ISO 16140-2:2016

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CHF 199
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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).

General information

  • Status
     : Published
    Publication date
     : 2016-06
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 1
    Number of pages
     : 66
  • Technical Committee :
    ISO/TC 34/SC 9
    ICS :
    07.100.30 
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 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

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

Edition 2024

Language
Format
CHF 132
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