NF EN ISO 15194
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
Le présent document spécifie les prescriptions et les présentations requises pour la description des matériaux de référence. Il ne traite pas de la fabrication des matériaux de référence.
- Avant-proposiv
- Introductionv
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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 Présentation systématique des propriétés dans la documentation associée à un matériau de référence certifié4
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4.1 Présentation des propriétés4
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4.2 Composition des désignations systématiques5
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4.3 Noms communs5
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5 Propriétés, production et caractérisation d'un matériau de référence certifié5
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5.1 Rang dans la hiérarchie5
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5.2 Propriétés5
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5.3 Production et caractérisation6
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6 Contenu de la documentation associée6
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6.1 Documentation associée6
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6.2 Étiquette6
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6.3 Certificat6
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6.4 Rapport de certification7
- Annexe A (informative) Matériaux de référence certifiés ayant des propriétés nominales ou des grandeurs ordinales16
- Bibliographie17
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