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AS 16140.3:2022
[Current]Microbiology of the food chain — Method validation, Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021, MOD)
AS 16140.3:2022 adopts and modifies ISO 16140 3:2021, which specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory
Published: 29/04/2022
Pages: 72
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles of verification of qualitative (detection) methods and quantification methods
4.1 General
4.2 Implementation verification
4.3 (Food) item verification
4.4 Requirements for implementation verification and (food) item verification
4.5 Performance characteristics
5 Qualitative methods — Technical protocol for verification
5.1 Estimated LOD50 (eLOD50) determination
5.2 Experimental design
5.3 Selection of (food) items
5.4 Artificial contamination
5.4.1 Selection of strains
5.4.2 Inoculation of the test portions
5.5 Evaluation of results
5.5.1 Determination of eLOD50 using protocol 1
5.5.2 Determination of eLOD50 using protocol 2
5.5.3 Use of protocol 3
5.6 Acceptability limits
5.7 Root cause analysis
6 Quantitative methods — Technical protocol for verification
6.1 Intralaboratory reproducibility standard deviation determination
6.1.1 General
6.1.2 Experimental design
6.1.3 Selection of the (food) item
6.1.4 Natural contamination
6.1.5 Artificial contamination
6.1.5.1 Selection of the strain
6.1.5.2 Inoculation of the test portion
6.1.6 Evaluation of results
6.1.7 Acceptability limit
6.1.8 Root cause analysis
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
6.2.4.1 Selection of strains
6.2.4.2 Inoculation of the test portions
6.2.5 Evaluation of results
6.2.6 Acceptability limit
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
7.3.2 Strain selection
7.4 Evaluation of results
7.5 Acceptability limit
7.6 Root cause analysis
8 Summary of acceptability limits for the verification of validated methods
Annex A
Annex B
B.1 General
B.2 Matrix effects to consider
B.2.1 Microbial characteristics
B.2.2 Physical and chemical characteristics
B.2.3 Food process induced characteristics
B.3 Selection of (food) items for verification
Annex C
C.1 Method to be verified
C.2 Preparation for verification
C.3 Verification
Annex D
D.1 Determination of intralaboratory reproducibility standard deviation — Example
D.2 Determination of eBias — Example
D.2.1 Preparation for verification
D.2.2 Verification
Annex E
E.1 Alternative confirmation method verification — Example
E.2 Alternative typing method verification — Example
Annex F
F.1 General
F.2 (Food) item verification
F.3 Requirements for (food) item verification
F.4 Performance characteristics
F.5 Qualitative methods — Technical protocol for verification of a non-validated reference method
F.5.1 Estimated LOD50 (eLOD50) determination
F.5.2 Experimental design
F.5.3 Selection of (food) items
F.5.4 Artificial contamination
F.5.4.1 Selection of strains
F.5.4.2 Inoculation of the test portions
F.5.5 Evaluation of results
F.5.6 Acceptability limits
F.5.7 Root cause analysis
F.6 Quantitative methods — Technical protocol for verification of a non-validated reference method
F.6.1 Intralaboratory reproducibility standard deviation determination
F.6.2 Estimated bias (eBias) determination
F.7 Summary of acceptability limits
Bibliography
Appendix ZZ
ZZ.1 Scope
ZZ.2 Modifications
Cited references in this standard