NF EN ISO 16140-2

NF EN ISO 16140-2

September 2016
Standard Current

Microbiology of the food chain - Method validation - Part 2 : protocol for the validation of alternative (proprietary) methods against a reference method

ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation. It is applicable to the validation of methods for 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, and - samples from the primary production stage. It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).

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Main informations

Collections

National standards and national normative documents

Publication date

September 2016

Number of pages

74 p.

Reference

NF EN ISO 16140-2

ICS Codes

07.100.30   Food microbiology

Classification index

V08-103-2

Print number

1

International kinship

ISO 16140-2:2016

European kinship

EN ISO 16140-2:2016
Sumary
Microbiology of the food chain - Method validation - Part 2 : protocol for the validation of alternative (proprietary) methods against a reference method

ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.

It is applicable to the validation of methods for 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, and

- samples from the primary production stage.

It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).

Replaced standards (2)
NF EN ISO 16140
October 2003
Standard Cancelled
Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods

<p>ISO 16140:2003 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuffs and environmental and veterinary samples for the validation of alternative methods which can be used in particular in the framework of the official control, and the international acceptance of the results obtained by the alternative method.</p> <p>It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003.</p> <p>Where an alternative method is used on a routine basis for internal laboratory use without the requirement to meet (higher) external criteria of quality assurance, a less stringent comparative validation of the alternative method than that set in ISO 16140:2003 may be appropriate.</p>

NF EN ISO 16140/A1
October 2011
Standard Cancelled
Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1

Le présent amendement porte principalement sur la refonte du paragraphe 6.3 relatif au protocole technique de validation des méthodes quantitatives. Les autres modifications concernent la modification des annexes Q, V et W et de la bibliographie.

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principes généraux de la validation des méthodes alternatives
  • 5 Méthodes qualitatives - Protocole technique de validation
  • 6 Méthodes quantitatives - Protocole technique de validation
  • Annexe A Classification de types d'échantillon et suggestions de combinaisons cibles pour les études de validation
  • Annexe B Ordre de préférence pour l'utilisation d'échantillons naturellement et artificiellement contaminés dans les études de validation
  • Annexe C Protocoles généraux de contamination par mélange et de contamination artificielle d'aliments
  • Annexe D Modèles de calcul de RLOD en utilisant les données provenant de l'étude comparative des méthodes
  • Annexe E Aspects à prendre en compte lors du choix des souches pour les études d'inclusivité et d'exclusivité
  • Annexe F Considérations pour les calculs du niveau de détection relatif (RLOD) entre laboratoires effectués dans le cadre d'une étude interlaboratoires
  • Annexe G Principe du profil d'exactitude pour la validation de modèles quantitatifs
  • Annexe H Application du profil d'exactitude dans l'étude comparative des méthodes
  • Annexe I Exemple d'application du profil d'exactitude pour une étude interlaboratoires
  • Bibliographie
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