Ylabs provides professional hydrodynamic testing services either for fast turnaround design iteration feedback or for full regulatory approval. Testing is conducted on all types of heart valve substitutes (aortic, mitral, pulmonary, tricuspid) in accordance with the most updated ISO 5840 standard (2015).
Pulsatile Flow Testing
The purpose of the pulsatile flow testing is to obtain key indicators of valve performance including regurgitant fraction, effective orifice area, and numerous others. Ylabs standard test methods include testing at various beat rates, cardiac outputs, and back pressures. In addition to pass/fail information in accordance with ISO 5840, these methods can show design parameters such as closing volume, leakage volume, and forward flow pressure drop. Along with quantitative data, Ylabs can provide video and photography of a device while operating, providing key information on valve performance and leaflets motion.
Using the BDC HDT-500 Pulse Duplicator we are able to document pressure and flow performance characteristics of your device at:
Valve diameter: up to 65 mm
Cardiac Outputs of 1 - 10 L/min
Beat rates of 2-240 BPM
Driving waveform: sinusoidal, arbitrary
Back pressures up to 350 mmHg
Steady Back-Flow Leakage Testing
The purpose of the steady back-flow leakage testing is to provide, in tabular and graphic form, the static leakage volume flow rate as a function of back pressure. Ylabs steady back-flow leakage test apparatus is capable to generate constant back pressures appropriate to the intended device application.
Pulsatile flow and steady back-flow leakage testing shall be performed while the heart valve substitute is deployed in a simulated conduit representing the intended implant site and deployed device diameters. Ylabs provides design, manufacturing and rationale for the simulated conduit required for your device testing.
HEART VALVES DURABILITY TESTING OR ACCELERATED WEAR TESTING (AWT)
According to the ISO 5840 standard, durability testing 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 testing and visual inspection of the samples shall be performed prior to the test, after completing the test and at least every 50 million cycles during 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 testing service for regulatory submission. Sample size can be from one single valve and up to 12 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.
Fatigue testing is used for the characterisation of material properties and behavior during cyclic loading. Understanding the durability and limits of the device allows medical device manufacturers to bring safe and reliable products to market.
Due to the regulation and risk of medical device applications, fatigue testing must be performed to the appropriate stress levels, sample size, and standards according to well-defined test protocols.
Simultaneously testing up to 6 specimens
Up to 120 Hz. Amplitude up to ±10mm
Independent force measurement for each specimen with high statistical confidence level
Ylabs consulting services include:
Building the design verification and validation (V&V) test plan
Perform literature review and analyze test data to determine and justify boundary conditions
Development of test methods and equipment
Design (using CAD) and manufacturing of test jigs and fixtures
Design and manufacturing of dedicated testing and/or control systems
Writing of software code required for the testing
Writing of the required documentation for regulatory submissions (test protocol, test reports, rationale, etc...)