A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe

Matteo Di Nardo; Leen Vercaemst; Justyna Swol; Nicholas Barret; Fabio S. Taccone; Maximilian V. Malfertheiner; Lars M. Broman; Federico Pappalardo; Jan Belohlavek; Thomas Mueller; Roberto Lorusso; Margherita Lonero; Mirko Belliato

doi:10.1177/0267659118772452

A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe

Matteo Di Nardo, Leen Vercaemst, Justyna Swol, Nicholas Barret, Fabio S. Taccone, Maximilian V. Malfertheiner, Lars M. Broman, Federico Pappalardo, Jan Belohlavek, Thomas Mueller, Roberto Lorusso, Margherita Lonero, Mirko Belliato

Research output: Contribution to journal › Article › peer-review

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	https://doi.org/10.1177/0267659118772452
Publication status	Accepted/In press - Apr 1 2018

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

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10.1177/0267659118772452

Cite this

Di Nardo, M., Vercaemst, L., Swol, J., Barret, N., Taccone, F. S., Malfertheiner, M. V., Broman, L. M., Pappalardo, F., Belohlavek, J., Mueller, T., Lorusso, R., Lonero, M., & Belliato, M. (Accepted/In press). A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe. Perfusion (United Kingdom). https://doi.org/10.1177/0267659118772452

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AU - Di Nardo, Matteo

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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

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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.

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KW - oxygenators

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A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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