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

 

Test Procedure

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.

Performance parameters:

  • 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.

Performance parameters:

  • Measure of static leakage flow

 

Burst Pressure

Pressure at which device failure occurs.

Static Migration

Pressure at which devices migrates.

 

 

Equipment

  • Steady Flow test bench
  • Pump
  • Data acquisition system ±15mV with Software
  • Calibrated Standard nozzles
  • Calibrated thermometer
  • Calibrated Manometer
  • Calibrated Flow Meter
  • Thermo-regulated tank

Measured Parameters

  • 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

Scope

  • 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

Service Levels

Applicable Standards

  • ISO 5840-2:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

  • ISO 5840-3:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

  • ISO 5840-1:2021
    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

Related Tests

OLE0911, OLE0912, OLE0920, OLE0937


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