BS PD ISO/TR 19024:2016 recommends acceptable methodology for conducting gaseous microemboli (GME)testing and discusses limitations of current test methods. Tests described in this document are limitedto those conducted using an in vitro circulatory system.This document is applicable to all devices intended for extracorporeal circulatory support duringcardiopulmonary bypass (CPB). It outlines approaches currently used to assess the ability of CPBdevices to handle GME.
BS PD ISO/TR 19024:2016
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Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
BSI Group , 08/31/2016
Pages: 18
