Norm

NPR-CEN/TR 14060:2014 Ontw. en

Herleidbaarheid van medische hulpmiddelen door middel van unique device identification (UDI)

  • Deze norm is ingetrokken sinds 12-12-2014

23,50

Over deze norm

Status Ingetrokken
Aantal pagina's 12
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-02-2014
Taal Engels
This Technical Report describes the current situation for medical device traceability in Europe and identifies key elements to establish a comprehensive European traceability system that would provide full traceability to the individual patient level. This Technical Report applies to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories. Other devices which are custom-made or intended for clinical investigations and those in vitro diagnostic medical devices which are manufactured in health institutions and for performance evaluation are out of the scope of this document.

Details

ICS-code 11.040.01
Nederlandse titel Herleidbaarheid van medische hulpmiddelen door middel van unique device identification (UDI)
Engelse titel Medical device traceability enabled by unique device identification (UDI)
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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