International Standard
ISO 15194:2009
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
Reference number
ISO 15194:2009
Edición 2
2009-05
International Standard
Vista previa
ISO 15194:2009
42022
No disponible en español
Publicado (Edición 2, 2009)
Esta norma se revisó y confirmó por última vez en 2015. Por lo tanto, esta versión es la actual.

ISO 15194:2009

ISO 15194:2009
42022
Idioma
Formato
CHF 96
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

Informaciones generales

  •  : Publicado
     : 2009-05
    : Norma Internacional para revisar [90.92]
  •  : 2
     : 16
  • ISO/TC 212
    11.100.10 
  • RSS actualizaciones

Próxima versión en desarrollo

Draft International Standard
ISO/DIS 15194
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
Reference number
ISO/DIS 15194
Edición 1
Draft
International Standard

ISO/DIS 15194

In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation

ISO/DIS 15194

ISO/DIS 15194
82666
Idioma
Formato
CHF 63
Convertir Franco suizo (CHF) a tu moneda

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