NF EN ISO 15194

NF EN ISO 15194

October 2009
Standard Current

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.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2009

Number of pages

27 p.

Reference

NF EN ISO 15194

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-020

Print number

1 - 19/11/2009

International kinship

ISO 15194:2009

European kinship

EN ISO 15194:2009
Sumary
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.

Replaced standards (1)
NF EN 12287
October 1999
Standard Cancelled
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials

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.

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Présentation systématique des propriétés dans la documentation associée à un matériau de référence certifié
    4
  • 4.1 Présentation des propriétés
    4
  • 4.2 Composition des désignations systématiques
    5
  • 4.3 Noms communs
    5
  • 5 Propriétés, production et caractérisation d'un matériau de référence certifié
    5
  • 5.1 Rang dans la hiérarchie
    5
  • 5.2 Propriétés
    5
  • 5.3 Production et caractérisation
    6
  • 6 Contenu de la documentation associée
    6
  • 6.1 Documentation associée
    6
  • 6.2 Étiquette
    6
  • 6.3 Certificat
    6
  • 6.4 Rapport de certification
    7
  • Annexe A (informative) Matériaux de référence certifiés ayant des propriétés nominales ou des grandeurs ordinales
    16
  • Bibliographie
    17
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