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
1 Pediatric Intensive Care Unit, Children's Hospital Bambino Gesù, IRCCS, Rome, Italy.
2 Department of Perfusion, University Hospital Gasthuisberg, Louvain, Belgium.
Perfusion. 2018 Oct;33(7):553-561. doi: 10.1177/0267659118772452. Epub 2018 May 24.
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.
本综述总结了欧洲在引入新产品时控制市场的规则。特别是，它展示了获得欧洲合格认证（CE标志）的所有步骤，所有新的医疗产品在欧洲使用前都必须获得该认证。体外膜肺氧合（ECMO）设备也需遵循相同的程序。在此，我们提出一些关于泵和氧合器的监管问题，并提供制造商在其网站和信息图表上发布的技术细节。
