PD ISO/TR 19024:2016

This standard PD ISO/TR 19024:2016 Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document recommends acceptable methodology for conducting gaseous microemboli (GME) testing and discusses limitations of current test methods. Tests described in this document are limited to those conducted using an in vitro circulatory system.

This document 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.