Norm

NEN-EN 14136:2004 en

Gebruik van externe kwaliteitsbeoordelingsschema's in de beoordeling van eigenschappen van in-vitro diagnostische onderzoeksprocedures

49,30

Over deze norm

Status Definitief
Aantal pagina's 11
Commissie In vitro diagnostica
Gepubliceerd op 01-05-2004
Taal Engels
This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: - scheme design and organisation; - identification of procedures (IVD MDs) used by the participant; - classification and evaluation of data. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

Details

ICS-code 11.100.10
Nederlandse titel Gebruik van externe kwaliteitsbeoordelingsschema's in de beoordeling van eigenschappen van in-vitro diagnostische onderzoeksprocedures
Engelse titel Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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