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

Jazyk:	angličtina
Rok vydání:	2018
Předmět:	oxygenators centrifugal pumps ISO DP3 ECMO ECLS
Zdroj:	Perfusion. 33(7):553-561
ISSN:	1477-111X 0267-6591
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=od________83::0c77c45bfda572be560c2c99ea4d8be4 https://cris.maastrichtuniversity.nl/en/publications/c1759b98-32c5-4abb-8c2e-e5467292799e Zobrazit plný text záznamu