ISO/TR 19024:2016 recommends acceptable methodology for conducting gaseous microemboli (GME) testing and discusses limitations of current test methods. Tests described in ISO/TR 19024:2016 are limited to those conducted using an in vitro circulatory system.
It is applicable to all devices intended for extracorporeal circulatory support during cardiopulmonary bypass (CPB). It outlines approaches currently used to assess the ability of CPB devices to handle GME.