I.S. EN ISO 16140-6:2019
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Microbiology of the food chain - Method validation - Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (ISO 16140-6:2019)
Hardcopy , PDF
English
22-12-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles for the validation of confirmation and typing methods
5 Strains
6 Method comparison study
7 Interlaboratory study
Annex A (normative) Points to be considered when selecting strains for testing inclusivity and exclusivity
Annex B (informative) Example of the validation of an alternative confirmation method to the species level (Listeria monocytogenes)
Annex C (informative) Example of the validation of an alternative typing method to the Salmonella serovar level (15 different serovars claimed)
Annex D (normative) Overview of the various options for validation under this document and the acceptability limits
Bibliography
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