DIN EN ISO 16140-6:2020-04
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); German version EN ISO 16140-6:2019
| Fecha edición: |
2020-04-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e. g. whole genome sequencing). This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated microorganisms in: foodstuffs, feeding stuffs, environmental samples and samples from primary production stage. This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method or a molecular method. This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms. Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4). |
| Keywords: | Acknowledgements|Analysis|Animal feed|Copyright|Definitions|Evaluations|Food inspection|Food products|Food testing|Identification|Instructions|Laboratory testing|Methods|Methods of analysis|Microbiological analysis|Microbiology|Microorganisms|Reference methods|Regulations|Sequence of operations|Test specification|Testing|Type tests|Typing procedures|Validation|Verification|Works |
| ICS: | 07.100.30 - Microbiología de los alimentos |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 16140-6:2019 Idéntica ISO 16140-6:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 16140-6:2018-02 |
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