Durability and particulate testing system and method

A medical device durability and particulate tester system comprising:

• a durability tester component fluidically connected to a particulate counting component and a fluid management component;
• a simulated blood fluid for circulation through said system;
• said durability tester component comprising one or more testing chambers each configured for selectively housing a medical device to be tested;
• said one or more testing chambers fluidically connected to said fluid management component via a fluid inflow line;
• said durability tester component further comprising one or more compressible bellows each fluidically connected to one of said testing chambers;
• each said bellows attached to a pivotable swash plate;
• a drive motor having a rotatable rod, said rod comprising a coupling configured for engaging with said swash plate such that rotation of said rod tilts said swash plate in an oscillating pattern;
• wherein said tilting of said swash plate is configured for alternatingly compressing and expanding said one or more bellows;
• wherein said alternating compression and expansion of said one or more bellows is configured for actuating said medical device within each said testing chamber;
• each said bellows comprising a fluid outflow line to said particulate counting component;
• wherein said particulate counting component is configured for counting particles within fluid downstream of said one or more testing chambers;
• said fluid management component comprising a fluid pump;
• a controller having a processor configured for controlling actuation of said motor and said fluid pump;
• and
• wherein said system is configured for continuous flow of simulated blood fluid through said system and simultaneously testing durability and particulate shed of said medical device within each said testing chamber for a simulated expected use time frame for said medical device.