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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

Publication date:   Aug 12, 2016

General information

60.60 Standard published   Aug 12, 2016

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

Technical Report

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

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PUBLISHED
ISO/TR 19024:2016
60.60 Standard published
Aug 12, 2016