This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.
A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe
Pappalardo, Federico;
2018-01-01
Abstract
This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.File in questo prodotto:
| File | Dimensione | Formato | |
|---|---|---|---|
|
A narrative review of the technical standards for.pdf
solo gestori archivio
Tipologia:
PDF editoriale (versione pubblicata dall'editore)
Licenza:
Tutti i diritti riservati
Dimensione
111.08 kB
Formato
Adobe PDF
|
111.08 kB | Adobe PDF | Visualizza/Apri Richiedi una copia |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
