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.
| Original language | English |
|---|---|
| Journal | Perfusion (United Kingdom) |
| DOIs | |
| Publication status | Accepted/In press - Apr 1 2018 |
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Keywords
- centrifugal pumps
- ECLS
- ECMO
- ISO
- oxygenators
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Safety Research
- Cardiology and Cardiovascular Medicine
- Advanced and Specialised Nursing
Cite this
A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe. / Di Nardo, Matteo; Vercaemst, Leen; Swol, Justyna; Barret, Nicholas; Taccone, Fabio S.; Malfertheiner, Maximilian V.; Broman, Lars M.; Pappalardo, Federico; Belohlavek, Jan; Mueller, Thomas; Lorusso, Roberto; Lonero, Margherita; Belliato, Mirko.
In: Perfusion (United Kingdom), 01.04.2018.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe
AU - Di Nardo, Matteo
AU - Vercaemst, Leen
AU - Swol, Justyna
AU - Barret, Nicholas
AU - Taccone, Fabio S.
AU - Malfertheiner, Maximilian V.
AU - Broman, Lars M.
AU - Pappalardo, Federico
AU - Belohlavek, Jan
AU - Mueller, Thomas
AU - Lorusso, Roberto
AU - Lonero, Margherita
AU - Belliato, Mirko
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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.
AB - 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.
KW - centrifugal pumps
KW - ECLS
KW - ECMO
KW - ISO
KW - oxygenators
UR - http://www.scopus.com/inward/record.url?scp=85047398434&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85047398434&partnerID=8YFLogxK
U2 - 10.1177/0267659118772452
DO - 10.1177/0267659118772452
M3 - Article
AN - SCOPUS:85047398434
JO - Perfusion
JF - Perfusion
SN - 0267-6591
ER -