Norm

NPR-CEN/CLC/TR 14060:2014 en

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

49,30

Over deze norm

Status Definitief
Aantal pagina's 12
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-12-2014
Taal Engels
NPR-CEN/CLC/TR 14060 identifies key elements needed for a European system that would provide 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)
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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