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BS EN ISO 16140-6:2019

BS EN ISO 16140-6:2019

$167.15

Microbiology of the food chain. Method validation – Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

Published By Publication Date Number of Pages
BSI 2019 36
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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:

  • 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 alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:

  • the reference method;

  • an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars specified in the validation study of the alternative confirmation method is used.

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).

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
13 4 General principles for the validation of confirmation and typing methods
14 5 Strains
6 Method comparison study
6.1 General
6.2 Selection of test strains
6.3 Inclusivity study
6.3.1 Testing of target strains
15 6.3.2 Family level (non-Salmonella)
6.3.3 Genus level (non-Salmonella)
6.3.4 Species level (non-Salmonella)
6.3.5 Microbial (sub)type level (non-Salmonella)
6.3.6 Salmonella genus or species level
16 6.3.7 Salmonella serovar level
6.4 Exclusivity study
6.4.1 Testing of non-target strains
6.4.2 Family level (non-Salmonella)
6.4.3 Genus level (non-Salmonella)
6.4.4 Species level (non-Salmonella)
6.4.5 Microbial (sub)type level (non-Salmonella)
17 6.4.6 Salmonella genus or species level
6.4.7 Salmonella serovar level
6.5 Expression and interpretation of results
19 6.6 Evaluation
20 7 Interlaboratory study
7.1 General
7.2 Data sets to be obtained
21 7.3 Protocol
22 7.4 Expression of results
7.5 Interpretation and evaluation
24 Annex A (normative) Points to be considered when selecting strains for testing inclusivity and exclusivity
26 Annex B (informative) Example of the validation of an alternative confirmation method to the species level (Listeria monocytogenes)
29 Annex C (informative) Example of the validation of an alternative typing method to the Salmonella serovar level (15 different serovars claimed)
33 Annex D (normative) Overview of the various options for validation under this document and the acceptability limits
35 Bibliography

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BS EN ISO 16140-6:2019
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