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Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
Translate name
STANDARD published on 1.6.2020
Designation standards: ČSN EN ISO 16140-6
Classification mark: 560078
Catalog number: 509731
Publication date standards: 1.6.2020
SKU: NS-994079
The number of pages: 40
Approximate weight : 120 g (0.26 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
This document specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e.g. whole genome sequencing).
This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated microorganisms in:
Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:
This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case basis.
Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140 4)
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