ISO 16140-3:2021 Microbiology of the food chain — Method validation —Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory

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Microbiology of the food chain — Method validation —Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory是于2021-01发布的ISO标准，适用于全球。

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Microbiology of the food chain — Method validation —

Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory

1 Scope

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.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 6887 (all parts), Microbiology of the food chain — Preparation of test samples, initial suspension and decimal dilutions for microbiological examination

ISO 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations

ISO 16140-1:2016, Microbiology of the food chain — Method validation — Part 1: Vocabulary

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 16140-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www. iso .org/ obp

— IEC Electropedia: available at http:// www.e lectropedia. org/

3.1

alternative confirmation or typing method

confirmation or typing method submitted for validation

method of analysis that confirms or types the same analyte as is confirmed or typed using the corresponding reference method

Note 1 to entry: The method can be proprietary. The term “alternative” is used to refer to the entire “test procedure and reaction system”. This term includes all ingredients, whether material or otherwise, required for implementing the method.

[SOURCE: ISO 16140-6:2019, 3.2, modified — Note 2 to entry has been deleted.]

3.2

bias

measurement bias

estimate of a systematic measurement error, or the systematic difference between the quantitative assigned value and the average of measurement replicate results

[SOURCE: ISO 16140-1:2016, 2.9]

3.3

(food) category

group of (food) types (3.18) of the same origin

EXAMPLE Food category: heat-processed milk and dairy products. Food type: pasteurized dairy products. Food item: crème brûlée.

Note 1 to entry: The (food) categories are listed in Annex A.

[SOURCE: ISO 16140-1:2016, 2.11, modified — In the term, “(food)” has been added before “category”. In the definition, “(food)” has replaced “sample”. The example has been modified to align with the terms used in Annex A. Note 1 to entry has been added.]

3.4

estimated bias

eBias

determination of the bias (3.2) based on the experimental design described in this document (i.e. ISO 16140-3)

Note 1 to entry: An accurate determination of the bias is not possible as the number of samples tested is small. Therefore, the term “estimated bias” (“eBias”) is used in this document.

3.5

estimated LOD

50

eLOD

50

determination of the LOD (level of detection at 50 % probability of detection) based on the 50

experimental design described in this document

Note 1 to entry: An accurate determination of the LOD is not possible as the number of samples tested is small 50

in comparison to the number of samples required in ISO 16140-2:2016. Therefore, the term “estimated LOD ” 50

(“eLOD ”) is used in this document.

50

Note 2 to entry: LOD is defined in ISO 16140-1:2016, 2.35.

50

3.6

exclusivity study

study involving pure non-target strains (3.11), which can be potentially cross-reactive, but are not expected to be detected or enumerated by the alternative method

[SOURCE: ISO 16140-1:2016, 2.22]

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