Steady Flow Testing – Hydrodynamic Performance
Hydrodynamic Performance Steady flow testing determines the forward and reverse flow performance characteristics of a valve in a simple and highly controlled manner. While no formal acceptance criteria exists for steady flow testing, it can be useful in confirming results of pulsatile flow testing.
Includes: Steady Forward flow testing, Steady back flow leakage testing, Stent Post Deflection, Migration, and Burst Testing
Steady Forward-Flow Testing
Measurement of the pressure difference across the test valve and the standard nozzle over a flow range of 5 to 30 l/min in 5 l/min increments. Collecting and recording of at least five measurements at each flow rate.
- Measure of the transvalvular pressure gradient
- Evaluate the Effective Orifice Area (EOA) of the valve
Steady Back-Flow Leakage Testing
Measurement of the static leakage across the test valve and the standard nozzle at five equidistant back-pressures in the range of 40 to 200 mmHg. Collecting and recording of at least five measurements at each level of back pressure.
- Measure of static leakage flow
Pressure at which device failure occurs.
Pressure at which devices migrates.
- Steady Flow test bench
- Data acquisition system ±15mV with Software
- Calibrated Standard nozzles
- Calibrated thermometer
- Calibrated Manometer
- Calibrated Flow Meter
- Thermo-regulated tank
- Mean transvalvular pressure gradient at each flow rate
- Effective Orifice Area (EOA) of the valve at each flow rate
- Mean static leakage flow rate (transvalvular and paravalvular) at each back pressure
- Surgical Valves: SAVR, SMVR, SPVR, STVR
- Transcatheter Valves: TAVI / TAVR, TMVI / TMVR, TPVI / TPVRTMVR, TTVR / TTVI and any other transcatheter valve
- Biological, Polymeric, mechanical valves, tissue engineered
- Artificial heart valves prosthesis
- Venous valves
- Valvular conduits
- Any valvular prosthesis
- Any cardiac repair device
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
NF EN 12006-1
Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 1 : heart valve substitutes
- Pulsatile Flow Testing – Hydrodynamic Performance
- Accelerated Wear Testing (AWT)
- Steady Flow Testing – Stent Post Deflection
OLE0911, OLE0912, OLE0920, OLE0937
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