Valve Durability

According to the ISO 5840 standard, valve durability testing, also know as Accelerated Wear Testing (AWT), is performed to ensure that the heart valve substitute remains functional for at least 200 million in vitro test cycles. The samples to be tested shall be manufactured (including sterilization) according to the final design and manufacturing specifications. Prior to testing, the samples shall be subjected to Simulated Use: Crimp (load into delivery system), Tracking simulation and Deployment. The standard also requires verification of the test setup parameters by use of appropriate reference valve with known clinical data (control sample). Hydrodynamic pulsatile flow testing and visual inspection of the samples shall be performed prior to the test, at least every 50 million cycles during the test and after completing the test.

Ylabs uses BDC VDT-3600i heart valve durability testers to provide short term (from 5-10 and up to 30-40 million cycles) testing service, for fast turnaround design iteration feedback, as well as long term 200 million cycles testing service for regulatory submission. Sample size can be from one single valve and up to 24 samples (depending on customer needs). Testing can be performed on all types of heart valve substitutes (aortic, mitral, pulmonary, tricuspid) at frequencies from 1 to 50 Hz and with a Max. differential pressure of 500 mmHg.