NF ISO 8196-3
Milk - Definition and evaluation of the overall accuracy of alternative methods of milk analysis - Part 3 : protocol for the evaluation and validation of alternative quantitative methods of milk analysis
ISO 8196-3¦IDF 128-3:2009 specifies a protocol for the evaluation and validation of alternative quantitative methods of milk analysis.The protocol is applicable to all milk components including somatic cells. For microbiological parameters other standards, such as ISO 16140, apply. ISO 8196-3¦IDF 128-3:2009 is also applicable to the validation of new alternative methods where a limited number of analysts does not allow the organization of an interlaboratory study and ISO 8196-1¦IDF 128-1, therefore, does not apply.ISO 8196-3¦IDF 128-3:2009 also establishes general principles of a procedure for granting international approvals of these alternative methods. These principles are based on the validation protocol defined in ISO 8196-3¦IDF 128-3:2009.
ISO 8196-3¦IDF 128-3:2009 specifies a protocol for the evaluation and validation of alternative quantitative methods of milk analysis.
The protocol is applicable to all milk components including somatic cells. For microbiological parameters other standards, such as ISO 16140, apply. ISO 8196-3¦IDF 128-3:2009 is also applicable to the validation of new alternative methods where a limited number of analysts does not allow the organization of an interlaboratory study and ISO 8196-1¦IDF 128-1, therefore, does not apply.
ISO 8196-3¦IDF 128-3:2009 also establishes general principles of a procedure for granting international approvals of these alternative methods. These principles are based on the validation protocol defined in ISO 8196-3¦IDF 128-3:2009.
This document specifies a protocol for the evaluation and validation of alternative quantitative methods of milk analysis. This document is also applicable for the validation of new alternative methods where, due to a limited number of operational instruments, the execution of an interlaboratory study and ISO 8196-1 | IDF 128-1 is not feasible. The protocol is applicable to milk parameters such as, for example, fat, protein, lactose, urea and somatic cells in milk. It can also be extended to other parameters. This document also establishes the general principles of a procedure for granting international approvals for the performance of the alternative methods. These principles are based on the validation protocol defined in this document.
- Avant-proposiv
- Avant-proposv
- IntroductionVI
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions2
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4 Principes généraux relatifs à la validation des méthodes alternatives3
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4.1 Protocole de validation3
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4.2 Domaine de validité de l'agrément3
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5 Protocole technique de validation4
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5.1 Déroulement des opérations4
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5.2 Étude comparative des méthodes4
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5.3 Rapport et délivrance d'un agrément17
- Annexe A (informative) Processus de mesure et précision globale19
- Annexe B (informative) Limites relatives aux caractéristiques de performance avec un lait cru20
- Annexe C (informative) Exemples de calcul23
- Annexe D (informative) Résumé des formules statistiques relatives aux évaluations des méthodes38
- Annexe E (informative) Mode opératoire de préparation d'une série d'échantillons lors de l'évaluation de la linéarité43
- Bibliographie47
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