Di Nardo, Matteo and Vercaemst, Leen and Swol, Justyna and Barret, Nicholas and Taccone, Fabio S. and Malfertheiner, Maximilian V. and Broman, Lars M. and Pappalardo, Federico and Belohlavek, Jan and Mueller, Thomas and Lorusso, Roberto and Lonero, Margherita and Belliato, Mirko (2018) A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe. PERFUSION-UK, 33 (7). pp. 553-561. ISSN 0267-6591, 1477-111X
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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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DP3; ISO; ECLS; ECMO; oxygenators; centrifugal pumps |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Petra Gürster |
| Date Deposited: | 10 Jul 2020 08:29 |
| Last Modified: | 10 Jul 2020 08:29 |
| URI: | https://pred.uni-regensburg.de/id/eprint/13808 |
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