BAS EN ISO 14155-2:2010
Kliničko ispitivanje medicinskih sredstava za ljude – dio 2: Planovi kliničkog ispitivanja
Opšte informacije
Status: Povučen
Broj strana: 14
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 25.06.2010
Tehnički komitet:
Direktiva:
90/385/EEC, Aktivna ugradiva medicinska sredstva
93/42/EEC, Medicinska sredstva;
93/42/EEC, Medicinska sredstva;
...
Apstrakt
1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 14155-2:2009, identičan
- ISO 14155-2:2003, identičan