NF EN ISO 16140

NF EN ISO 16140

October 2003
Standard Cancelled

Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods

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. It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003. 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.

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National standards and national normative documents

Publication date

October 2003

Number of pages

74 p.

Reference

NF EN ISO 16140

ICS Codes

07.100.30   Food microbiology

Classification index

V08-103

Print number

1 - 24/12/2003

International kinship

ISO 16140:2003

European kinship

EN ISO 16140:2003
Sumary
Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods

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.

It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003.

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.

Standard replaced by (2)
NF EN ISO 16140-1
September 2016
Standard Current
Microbiology of the food chain - Method validation - Part 1 : vocabulary

ISO 16140-1:2016 defines general terms and definitions relating to method validation of microbiology in the food chain. 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.

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).

Table of contents
  • Avant-propos
    4
  • Introduction
    5
  • 1
    Domaine d'application 5
  • 2
    Références normatives 5
  • 3
    Termes et définitions 6
  • 4
    Principes généraux de la validation et de la certification des méthodes alternatives 7
  • 5
    Méthodes qualitatives - Protocole technique de validation 8
  • 6
    Méthodes quantitatives - Protocole technique de validation 17
  • Annexe A (normative) Règles spécifiques relatives à l'acceptation de résultats externes obtenus dans le cadre d'un programme de validation antérieur
    30
  • Annexe B (informative) Classification des types d'échantillons pour les études de validation
    31
  • Annexe C (normative) Utilisation d'échantillons naturellement contaminés et préparation d'échantillons artificiellement contaminés dans les études de validation
    34
  • Annexe D (normative) Duplication des échantillons pour la détermination de l'exactitude relative et du niveau de détection relatif des méthodes qualitatives
    35
  • Annexe E (normative) Calcul des intervalles de confiance associés au nombre d'échantillons soumis à essai
    37
  • Annexe F (normative) Essai utilisé pour l'examen des résultats discordants
    38
  • Annexe G (normative) Aspects à prendre en compte lors du choix des souches pour établir la sélectivité
    39
  • Annexe H (normative) Lignes directrices relatives à l'organisation et à la gestion des études collaboratives
    41
  • Annexe I (normative) Détermination de l'absence de l'analyte cible dans les témoins négatifs
    43
  • Annexe J (normative) Réplication des échantillons pour les études interlaboratoires des méthodes qualitatives
    44
  • Annexe K (normative) Examen des données
    46
  • Annexe L (informative) Étude interlaboratoire de méthodes qualitatives critères d'accord, de concordance et de ratio de chances de concordance
    47
  • Annexe M (normative) Réplication des échantillons pour la détermination de l'exactitude relative des méthodes quantitatives
    52
  • Annexe N (normative) Exemples de répartitions acceptables et inacceptables et domaines de mesures pour l'estimation de la droite de régression dans le cadre des méthodes quantitatives
    54
  • Annexe 0 (normative) Évaluation de la linéarité des méthodes quantitatives par représentation graphique
    55
  • Annexe P (normative) Limites de détection et de quantification des dénombrements
    56
  • Annexe Q (normative) Estimateur robuste de la dispersion sur la base de la médiane récursive Sn de Rousseeuw [6]
    58
  • Annexe R (normative) Calculs avec la méthode de régression
    59
  • Annexe S (normative) Exemples de calculs pour les méthodes quantitatives
    63
  • Annexe T (normative) Étude collaborative - Résultats d'essai circulaire avec réplicats
    68
  • Annexe U (informative) Liste des symboles
    69
  • Bibliographie
    70
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