NF EN ISO 16140-3

NF EN ISO 16140-3

February 2021
Standard 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)

This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory.This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing 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.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.The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2021

Number of pages

86 p.

Reference

NF EN ISO 16140-3

ICS Codes

07.100.30   Food microbiology

Classification index

V08-103-3

Print number

1

International kinship

ISO 16140-3:2021

European kinship

EN ISO 16140-3:2021
Sumary
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)

This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory.

This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing 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.

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.

The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principes généraux de vérification des méthodes qualitatives (recherche) et des méthodes quantitatives
  • 5 Méthodes qualitatives - Protocole technique de vérification
  • 6 Méthodes quantitatives - Protocole technique de vérification
  • 7 Méthodes alternatives validées de confirmation et de typage - Protocole technique de vérification
  • 8 Résumé des limites d'acceptabilité applicables à la vérification des méthodes validées
  • Annexe A (informative) Classification des catégories (d'aliments) et suggestions de combinaisons cibles pour les études de vérification
  • Annexe B (informative) Recommandations sur la façon de choisir une matrice (d'aliment) difficile ou des matrices (d'aliments) difficiles (challenging) pour la vérification des matrices (d'aliments)
  • Annexe C (informative) Vérification de la méthode qualitative - Exemple
  • Annexe D (informative) Vérification de la méthode quantitative - Exemple
  • Annexe E (informative) Vérification de la méthode alternative validée de confirmation ou de typage - Exemple
  • Annexe F (normative) Protocole pour la vérification dans un seul laboratoire de méthodes de référence non validées
  • Bibliographie
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