Norm

NEN-EN-ISO 15194:2009 en

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

79,70

Over deze norm

Status Definitief
Aantal pagina's 16
Commissie In vitro diagnostica
Gepubliceerd op 01-05-2009
Taal Engels
This International Standard 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. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard 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.

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
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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