Abstract

This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used. This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of microorganisms in: - products intended for human consumption; - products intended for animal feeding; - environmental samples in the area of food and feed production, handling; - samples from the primary production stage. Validated identification methods cannot be used instead of confirmation described in: - the reference method; - an alternative method validated in accordance with ISO 16140-2; - an alternative method validated in accordance with ISO 16140-6. In these instances, the identification method shall be validated in accordance with the ISO 16140-6 to be used as a confirmation method. 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.

Begin

2022-02-15

WI

00463103

Planned document number

DIN EN ISO 16140-7

Project number

05702590

Responsible national committee

NA 057-01-12 AA - Validation of microbiological methods  

Responsible european committee

CEN/TC 463 - Microbiology of the food chain  

Responsible international committee

ISO/TC 34/SC 9/WG 3 - Method validation  

draft standard

Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO/DIS 16140-7:2023); German and English version prEN ISO 16140-7:2023
2023-05
Order from DIN Media