NEN - NPR-CEN/TR 14060
Medical device traceability enabled by unique device identification (UDI)
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 February 2014 |
| Status: | inactive |
| Page Count: | 14 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
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.
Document History
NPR-CEN/TR 14060
February 1, 2014
Medical device traceability enabled by unique device identification (UDI)
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...