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

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

10 Citations (Web of Science)

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 languageEnglish
Pages (from-to)553-561
Number of pages9
JournalPerfusion
Volume33
Issue number7
DOIs
Publication statusPublished - 1 Oct 2018

Keywords

  • ISO
  • ECLS
  • ECMO
  • oxygenators
  • centrifugal pumps
  • DP3

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