Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-4:2020
International Standard
Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-4:2020
Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory
Edition 1
2020-07
Preview
Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-4:2020
66325
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Publicado (·¡»å¾±³¦¾±Ã³²Ô 1, 2020)
Esta norma tiene 1 modificaciones.

Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-4:2020

Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-4:2020
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Resumen

This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study.

This document is applicable to single-laboratory validation of:

— methods used in the analysis (detection or quantification) 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;

— methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G).

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.

Single-laboratory validation is required if an interlaboratory validation in accordance with Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-2 is not appropriate. Possible applications are:

— validation of an in-house method;

— method evaluation study in the validation process of a reference method in accordance with Ïã¸ÛÁùºÏ²Ê¿ª½± 17468;

— extension of the scope of an Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-2 validated method, e.g. category extension or test portion size;

— modifications of existing methods.

Single-laboratory validation is the second step in the standardization of a reference method (see Ïã¸ÛÁùºÏ²Ê¿ª½± 17468). It is only applicable to methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.

Informaciones generales

  •  : Publicado
     : 2020-07
    : Norma Internacional publicada [60.60]
  •  : 1
     : 46
  • Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 34/SC 9
    07.100.30 
  • RSS actualizaciones

 Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.

Amendment 1

Validation of a larger test portion size for qualitative methods

·¡»å¾±³¦¾±Ã³²Ô 2024

Ïã¸ÛÁùºÏ²Ê¿ª½± 16140-4:2020/Amd 1:2024
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