NF EN ISO 15194
NF EN ISO 15194

NF EN ISO 15194

November 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)

Le présent document spécifie des exigences concernant les matériaux de référence certifiés et le contenu de la documentation associée afin qu''ils soient considérés comme étant de niveau métrologique supérieur Il vient à l''appui des exigences essentielles de la Directive 98/79/CE sur les dispositifs médicaux de diagnostic in vitro.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2009

Release date

juillet 2029

Number of pages

27 p.

Reference

NF EN ISO 15194

ICS Codes

11.100.10   In vitro diagnostic test systems

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)

Le présent document spécifie des exigences concernant les matériaux de référence certifiés et le contenu de la documentation associée afin qu''ils soient considérés comme étant de niveau métrologique supérieur Il vient à l''appui des exigences essentielles de la Directive 98/79/CE sur les dispositifs médicaux de diagnostic in vitro.
Replaced standards (1)
NF EN 12287
NF EN 12287
January 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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