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BS EN ISO 16140-3:2021

BS EN ISO 16140-3:2021

$215.11

Microbiology of the food chain. Method validation – Protocol for the verification of reference methods and validated alternative methods in a single laboratory

Published By Publication Date Number of Pages
BSI 2021 88
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This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory.

This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing 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.

This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.

The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
Endorsement notice
9 Foreword
10 Introduction
17 1 Scope
2 Normative references
3 Terms and definitions
21 4 General principles of verification of qualitative (detection) methods and quantification methods
4.1 General
4.2 Implementation verification
22 4.3 (Food) item verification
4.4 Requirements for implementation verification and (food) item verification
25 4.5 Performance characteristics
5 Qualitative methods — Technical protocol for verification
5.1 Estimated LOD50 (eLOD50) determination
5.2 Experimental design
26 5.3 Selection of (food) items
5.4 Artificial contamination
5.4.1 Selection of strains
27 5.4.2 Inoculation of the test portions
29 5.5 Evaluation of results
5.5.1 Determination of eLOD50 using protocol 1
32 5.5.2 Determination of eLOD50 using protocol 2
33 5.5.3 Use of protocol 3
34 5.6 Acceptability limits
5.7 Root cause analysis
35 6 Quantitative methods — Technical protocol for verification
6.1 Intralaboratory reproducibility standard deviation determination
6.1.1 General
6.1.2 Experimental design
37 6.1.3 Selection of the (food) item
6.1.4 Natural contamination
6.1.5 Artificial contamination
38 6.1.6 Evaluation of results
39 6.1.7 Acceptability limit
40 6.1.8 Root cause analysis
41 6.2 Estimated bias (eBias) determination
6.2.1 General
6.2.2 Experimental design
6.2.3 Selection of (food) items
6.2.4 Artificial contamination
43 6.2.5 Evaluation of results
6.2.6 Acceptability limit
44 6.2.7 Root cause analysis
7 Validated alternative confirmation and typing methods — Technical protocol for verification
7.1 General
7.2 Implementation verification
7.3 Experimental design
7.3.1 General
45 7.3.2 Strain selection
7.4 Evaluation of results
46 7.5 Acceptability limit
7.6 Root cause analysis
8 Summary of acceptability limits for the verification of validated methods
47 Annex A (informative) Classification of (food) categories and suggested target combinations for verification studies
61 Annex B (informative) Guidance on how to choose challenging (food) item(s) for (food) item verification
63 Annex C (informative) Qualitative method verification — Example
71 Annex D (informative) Quantitative method verification — Example
76 Annex E (informative) Validated alternative confirmation or typing method verification — Examples
79 Annex F (normative) Protocol for the verification of non-validated reference methods in a single laboratory
86 Bibliography

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BS EN ISO 16140-3:2021
$215.11