| MSI has partnered with Protomed SA to provide heart valve testing services. Tests are performed under Quality System compliant with ISO 9001 & 13485 standards as well as GLP requirements.
Hydrodynamic Testing, Assessment of heart valve hydrodynamic performance is according to ISO/DIS standard 5840. Heart valves are tested under steady and pulsatile flow conditions to determine flow characteristics across the valve with blood analog.
Fatigue Testing, Dynatek M6 testers are used to assess the valve durability. Each M6 allows for up to six samples to be tested in six separate chambers by using a swash plate drive system. As the swash plate rotates, the bellows are compressed or extended causing fluid to flow through the test chamber. This allows for blood analog fluid to be dispersed into separate chambers, which enables independent pressure tuning. Tests are run under controlled and stabilized temperature. |
