Norm

NEN-EN-ISO 15194:2007 Ontw. en

In-vitro diagnostische systemen - Meting van grootheden in monsters van biologische oorsprong - Eisen voor gecertificeerde referentiematerialen en de inhoud van de ondersteunende documentatie

  • Deze norm is ingetrokken sinds 13-05-2009

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 18
Commissie In vitro diagnostica
Gepubliceerd op 01-02-2007
Taal Engels
This International Standard specifies requirements for certified reference materials (CRM) and the content of their supporting documentation for them to be considered of higher metrological order according to ISO 17511. It is applicable to CRMs classifiable as primary measurement standards, secondary measurement standards, and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how data shall be collected for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to CRMs with assigned values of differential or rational quantities. For nominal properties and ordinal quantities, see Annex A.

Details

ICS-code 11.100.10
Nederlandse titel In-vitro diagnostische systemen - Meting van grootheden in monsters van biologische oorsprong - Eisen voor gecertificeerde referentiematerialen en de inhoud van de ondersteunende documentatie
Engelse titel In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
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Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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