Typically, it is recommended to include (but not limited to) the following indicators in animal testing of ECMO products: blood-related laboratory test indicators; pathology-related indicators; vital signs and hemodynamic monitoring indicators; monitoring and recording of the main therapeutic parameters during the operation of the ECMO, observing changes in the appearance of the device, and monitoring for possible device malfunctions; regularly checking the cannulation site of the experimental animal for mechanical injury and signs of infection Signs of mechanical damage and infection at the intubation site of experimental animals; during animal testing, it is appropriate to record and analyze any safety events/abnormalities; during the necropsy of experimental animals, changes in the appearance of devices should be observed at the same time, and in-vitro performance testing can also be conducted on the recovered devices.

If it is necessary to verify some special functions and/or performance of the declared products, specific evaluation indexes for the relevant functions and/or performance can be selected, and the basis for determining the relevant evaluation indexes can be provided at the same time.

Evaluation Department V