BAS EN ISO 14971:2013
Medicinska sredstva – Primjena upravljanja rizikom kod medicinskih sredstava
Opće informacije
Status: Povučen
Broj strana: 98
Jezik: Engleski
Izdanje: 4.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 21.11.2013
Tehnički komitet:
Direktiva:
90/385/EEC, Aktivna ugradiva medicinska sredstva
93/42/EEC, Medicinska sredstva;
98/79/EC, Medicinska sredstva u in vitro dijagnostici;
93/42/EEC, Medicinska sredstva;
98/79/EC, Medicinska sredstva u in vitro dijagnostici;
...
Apstrakt
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 14971:2012, identičan
- ISO 14971:2007, identičan