Standard Tekniska rapporter · SIS-CEN/CLC/TR 14060:2016

Spårbarhet för medicintekniska produkter genom unik produktidentifiering (UDI)

Status: Gällande

This Technical Report 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.


Dokumentation av tekniska produkter (01.110) Medicinsk utrustning allmänt (11.040.01) Medicintekniska kvalitetssystem (11.110.10) Farmakopéprodukter allmänt (11.120.01)


Språk: Engelska

Framtagen av: Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik, SIS/TK 355

Internationell titel: Medical device traceability enabled by unique device identification (UDI)

Artikelnummer: STD-8019366

Utgåva: 1

Fastställd: 2016-03-09

Antal sidor: 24