NF EN 12287

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.

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Main informations

Collections

National standards and national normative documents

Publication date

October 1999

Number of pages

22 p.

Reference

NF EN 12287

ICS Codes

11.100.10   In vitro diagnostic test systems

Classification index

S92-020

Print number

1 - 30/09/2004

European kinship

EN 12287:1999
Sumary
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.
Standard replaced by (1)
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

<p>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.</p> <p>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.</p> <p>ISO 15194:2009 does not apply to reference materials that are parts of an <i>in vitro</i> diagnostic measuring system, although it is possible that many elements are helpful.</p>

Table of contents
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  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Termes et définitions
    5
  • 4 Classification et désignation des matériaux de référence
    6
  • 5 Description d'un matériau de référence
    8
  • 6 Étiquetage
    17
  • 7 Certificat
    17
  • 8 Notice d'accompagnement
    17
  • Annexe A (informative) Matériaux avec des propriétés autres que les grandeurs
    18
  • Annexe B (informative) Bibliographie
    19
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    20
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