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Normas DIN – AENOR
DIN EN ISO 16140-5:2018-02

DIN EN ISO 16140-5:2018-02

Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation of non-proprietary methods (ISO/DIS 16140-5:2017); German and English version prEN ISO 16140-5:2017 / Note: Date of issue 2018-01-05

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 5: Protocole pour la validation interlaboratoires de méthodes non propriétaires par plan factoriel (ISO/DIS 16140-5:2017); Version allemande et anglaise prEN ISO 16140-5:2017 / Attention: Date de parution 2018-01-05

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 5: Arbeitsvorschrift für eine faktorielle Ringversuch-Verfahrensvalidierung (ISO/DIS 16140-5:2017); Deutsche und Englische Fassung prEN ISO 16140-5:2017 / Achtung: Erscheinungsdatum 2018-01-05

Fecha Anulación:
2020-12 /Withdrawn
Equivalencias internacionales:

ISO/DIS 16140-5 (2017-12)

prEN ISO 16140-5 (2017-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 16140-5:2020-12

Resumen:
The proposed deliverable specifies an alternative technical protocol for the validation of mostly non-proprietary methods in the field of microbiological analysis of food, animal feed, and environmental and primary production stage samples. It is closely related to ISO 16140-2. The latter specifies the technical protocol for the validation of proprietary methods, including a classical interlaboratory study and a method comparison study to be conducted in one laboratory. The realization of classical interlaboratory studies demands a sufficient number of participating laboratories (at least 8 laboratories are required). There are many occasions where a sufficient number of participating laboratories is not available (e. g. when a new method is required quickly after an outbreak of a new microorganism). In this case, the validation cannot be considered as reliable any longer. The proposed deliverable uses a modified protocol based on orthogonal, factorial studies. By selection of suitable influencing factors (technician, nutrient media, sample preparation, temperature, duration) a high certainty of the determined method validation parameters is obtained, so that the number of required collaborating laboratories can be reduced up to a minimum of 4. This validation protocol can be used in different ways. If the 4 collaborators can be considered a "random sample" of independent and competent laboratories and from different organizations, the test method can be considered as being validated in the sense that accurate and precise measurements are to be expected from any competent laboratory. If the 4 collaborators can be considered a "random sample" of independent and competent laboratories from one organization, the test method can be considered as being validated in the sense that accurate and precise measurements are to be expected from any competent laboratory in this organization.
Keywords:
Analysis, Animal feed, Definitions, Evaluations, Factors, Food inspection, Food products, Food testing, Instructions, Inter-laboratory tests, Laboratory testing, Methods, Methods of analysis, Microbiological analysis, Microbiology, Microorganisms, Reference methods, Regulations, Sequence of operations, Test specification, Testing, Validation, Verification, Works
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