MDA 0306

Material REF: Reliable documents on Extracorporeal circulation devices (non-implantable) quality control, safety and efficacy requirements based on conformity assessment approach, specific standards and guidelines.

The below devices and other devices that can be categorized in this topic shall be considered in the training material. 

Haemodialysis machine and equipment, Cardiopulmonary bypass pump, Infusion pumps, Feeding pumps, Jet injectors for vaccination, Blood pumps for heart-lung machines, Anaesthesia machines and other devices.