NF EN ISO 16140-4

NF EN ISO 16140-4

August 2020
Standard Current

Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory

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 ISO 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 ISO 17468;— extension of the scope of an ISO 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 ISO 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.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

August 2020

Number of pages

63 p.

Reference

NF EN ISO 16140-4

ICS Codes

07.100.30   Food microbiology

Classification index

V08-103-4

Print number

1

International kinship

ISO 16140-4:2020

European kinship

EN ISO 16140-4:2020
Sumary
Microbiology of the food chain - Method validation - Part 4 : protocol for method validation in a single laboratory

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 ISO 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 ISO 17468;

— extension of the scope of an ISO 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 ISO 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.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principes généraux de la validation dans un seul laboratoire de méthodes de détection et de quantification
  • 5 Protocole technique de validation - Approche factorielle
  • 6 Protocole technique de validation - Approche conventionnelle
  • 7 Résumé des limites d'acceptabilité
  • Annexe A Liste des facteurs et niveaux de facteurs relatifs à la validation de la méthode factorielle
  • Annexe B Calcul de la reproductibilité interne applicable aux méthodes qualitatives d'après l'étude LOD50 décrite en 6.1.2.3
  • Annexe C Exemple d'étude factorielle de validation de méthodes dans un seul laboratoire pour une méthode quantitative par rapport à une méthode de référence
  • Annexe D Exemple d'étude factorielle de validation de méthodes dans un seul laboratoire pour une méthode qualitative par rapport à une méthode de référence
  • Annexe E Exemple d'étude factorielle de validation de méthodes dans seul un laboratoire pour la variabilité du LOD50 d'une méthode qualitative sans méthode de référence
  • Annexe F Détermination de la fidélité en cas d'échantillons artificiellement contaminés instables
  • Annexe G Protocole pour la validation dans un seul laboratoire de méthodes alternatives pour la confirmation microbiologique et le typage
  • Bibliographie
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ