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Home >> Application >> By Standard >> ISO >> ISO 5000~9999 >> ISO 5840 Heart valve prostheses testing methods

ISO 5840 Heart valve prostheses testing methods

ISO 5840 test standard is crucial, it is the definitive global standard for heart valve prostheses. This standard provides a structured, risk-based framework to ensure the safety, performance, and durability of these life-sustaining devices.

The standard is divided into several parts, with the most critical for testing being:

ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements.

ISO 5840-2:2021 - Part 2: Surgically implanted heart valve substitutes.

ISO 5840-3:2021 - Part 3: Transcatheter heart valve systems.

Special Considerations for Valve Type (ISO 5840-2 vs. 5840-3)

Test Category	Surgical Valve (ISO 5840-2)	Transcatheter Valve (ISO 5840-3)
Implant Procedure	Suture, holder, sizer testing.	Delivery system testing is paramount: trackability, deployment accuracy, retrieval.
Durability	Standard 400M+ cycle fatigue testing of the valve.	Same, but ADDITIONALLY requires crimp/compression fatigue testing. The valve must withstand being crimped into a catheter and then functioning.
Hydrodynamics	Tested in an "ideal" anatomical model.	Tested in simulated pathological anatomies (e.g., calcified, bicuspid, elliptical annuli) to reflect real-world challenges.
Particulate Matter	Standard requirement.	Extremely critical due to the interaction of the delivery system with vasculature. Quantification and characterization of particles shed during deployment is required.
Migration Force	Not applicable.	Must measure the force required to displace the implanted valve (e.g., using a balloon pull-back test) to prove secure anchoring.

Detailed Testing Framework as per ISO 5840

The testing progresses from fundamental material and component tests to comprehensive system-level and clinical validation.

Level 1: Material, Component, and Design Validation

These are the foundational tests to characterize the building blocks.

Material Characterization & Biocompatibility:

Purpose: To verify the chemical, physical, and mechanical properties of all raw materials (polymers, metals, tissues) and ensure they are biocompatible.
Key Tests:

Chemical Analysis: FTIR, DSC, GPC to identify material composition, purity, and degradation.
Mechanical Properties: Tensile, compression, tear strength, suture retention strength.
Biocompatibility (ISO 10993)

Component Performance:

Purpose: To test sub-assemblies (e.g., stent frame, leaflet assembly, delivery system).
Key Tests:

Stent Frame: Crimp/Compression resistance, radial force, chronic outward force, crush resistance, fatigue under dynamic loading.
Delivery System (for Transcatheter Valves): Trackability, pushability, deployment accuracy and force, re-sheathability, kink resistance, burst pressure.

Level 2: Device Verification (In Vitro/Bench Testing)

This is the core of engineering validation, simulating physiological conditions on a "pulse duplicator" or other fixtures.

Hydrodynamic Performance Testing:

Purpose: To quantify how well the valve functions as a one-way pump—its effective orifice area (EOA) and pressure gradient.
Method: The valve is mounted in a pulse duplicator—a machine that simulates the cardiac cycle (heart rate, cardiac output, systemic pressure). Test fluids mimic blood viscosity.
Key Metrics (Per ISO 5840-2/3):

Forward Flow Pressure Gradient: Mean and peak pressure drop across the open valve.
Effective Orifice Area (EOA): Calculated from flow and pressure data. A larger EOA indicates better hemodynamic performance.
Regurgitation: Total backflow per cycle, broken into:

Closure Volume: Minimal leak as leaflets coapt.
Leakage Volume: Pathological leak through closed leaflets.

Tests are performed at multiple cardiac outputs and heart rates to simulate different patient states (rest, exercise).

Fatigue/Durability Testing:

Purpose: To simulate a decade or more of heartbeat cycles in an accelerated manner to prove long-term structural integrity.
Method: Valves are placed in a accelerated wear tester submerged in saline at body temperature (37°C). They are cycled open/closed at a high rate (e.g., 10-20 Hz, much faster than a real heartbeat of 1-2 Hz).
Key Requirement: 200 million cycles is the absolute minimum, representing approximately 5 years of life. However, 400 million cycles (≈10 years) is the de facto industry standard for regulatory submissions. State-of-the-art testing often targets 600 million cycles (≈15 years). Post-test, the valve is inspected for leaflet tears, calcification simulation deposits, stent fracture, or wear.

Flow Visualization:

Purpose: To qualitatively and quantitatively assess the flow patterns through and downstream of the valve, identifying regions of potential concern.
Methods: Particle Image Velocimetry (PIV), Laser Doppler Velocimetry (LDV), or high-speed video with tracer particles.
Key Observations: Identification of stagnation zones (where blood pools, increasing clot risk), high shear stress regions (which can damage red blood cells, causing hemolysis), and turbulence.

Level 3: Pre-Clinical (In Vivo/Animal) Evaluation

Purpose: To evaluate device performance, delivery/implant procedure, and biological response in a living system before human trials.
Models: Typically sheep (for excellent size and coagulation similarity) or pigs.

Level 4: Sterilization, Packaging, and Shelf-Life

Sterilization Validation (ISO 11135/11137): Proof that the chosen method (e.g., Ethylene Oxide, radiation) achieves sterility without degrading the valve.
Packaging Validation (ISO 11607): Tests for integrity (seal strength) and the ability to withstand transportation hazards (drop, vibration, compression tests).
Shelf-Life/Real-Time Aging Studies: Valves are stored under anticipated conditions and tested periodically to prove performance remains within specification over the claimed shelf-life.

Specific operational procedure for in vitro durability testing of artificial heart valves

The core objective of in vitro durability testing of artificial heart valves is to verify the structural stability and functional integrity of the valves under long-term physiological loads through accelerated fatigue simulation. The testing must strictly comply with ISO 5840 series standards and GB 12279-2008 requirements. The process can be divided into six key steps, with each stage requiring precise control of parameters to ensure the validity and repeatability of the test results.

1. Pre-Test Preparation Phase

1.1. Sample Selection and Pretreatment

• Select 3-5 qualified products from the same batch (prior fluid mechanics and material compatibility tests must be completed), ensuring that the samples have no visible defects (such as leaflet damage, frame deformation, or loose sutures).

• Biological valves require simulated in vivo pretreatment.

1.2. Test System Setup and Calibration

• Core equipment: accelerated fatigue testing machine (including simulated circulation system, pressure/flow sensors, data acquisition module, and visual observation devices), constant temperature control unit, sterile storage tank.

• Simulation medium preparation: use sterile saline with anticoagulant (e.g., heparin, concentration 50-100 U/mL) to mimic the rheological properties of human blood, with the medium temperature maintained at 37±1°C (human core body temperature).

2. Test parameter setting (Key parts)

According to ISO 5840-1:2015, the parameters need to simulate the physiological load of the human body and achieve accelerated fatigue, with the following core settings:

Parameter type	Set the standard	Set the basis
Cycle frequency	180-300 times/min (commonly 240 times/min)	It is 3-4 times the resting heart rate of the human body (72 beats / minute), enabling accelerated testing and shortening the test cycle
Translobeal pressure difference	Peak systolic differential pressure 80-120 mmHg and diastolic differential pressure ≤ 5 mmHg	Simulate the load of the heart during human movement, covering physiological limit scenarios
Reflux rate	Test initial reflux rate ≤ 5% (consistent with hydrodynamic test baseline)	Ensure that the change in reflux rate during testing is quantifiable to reflect the attenuation of valve closure sealing
Accumulate the number of cycles	Mechanical valves ≥ 2×10⁹ times, biological valves ≥ 1×10⁹ times	Equivalent human 10-15 years of use (calculated at 7.3×10⁶ cycles per year)
Media change cycle	Replace the analog media every 1×10⁸ cycles	Avoid the aging of the medium and pollution affecting the test results, and maintain environmental stability

ISO 5840 Heart valve prostheses testing methods

3. Test operation and real-time monitoring

3.1. Continuous operation control

• After starting the test machine, the system is kept running continuously for 24 hours, the temperature of the medium is maintained by the thermostatic unit at 37±1°C, and the pressure/flow sensor collects data in real time (sampling frequency 10 Hz).

3.2. Monitoring and recording of key indicators

• Periodic testing (every 1×10⁸ cycles):

4. Test termination conditions

The test can be terminated if any of the following conditions are met:

1. The preset cumulative number of cycles (mechanical valve 2×10⁹ times, biological valve 1×10⁹ times) is reached, and the valve does not have structural failure and the attenuation of performance indicators is within the allowable range (cross-valve pressure difference increases by ≤20%, reflux rate ≤8%).

2. If the valve has irreversible structural failure (such as leaf tear, stent rupture, suture detachment), or the performance index exceeds the threshold (transvalve pressure difference increases by 30≥%, reflux rate ≥ 10%), it is judged as "test failure", and the number of failure cycles and failure mode are recorded.

3. If there is an irreparable equipment failure during the test and the cumulative number of cycles has ≥ 80% of the preset value, it can be treated as "partial valid data" to supplement the remaining cycle of sample retesting.

5. Sample analysis after testing

Appearance and structure inspection

• Disassemble the test fixture, remove the valve, rinse the surface with sterile PBS residual media, and observe the appearance:

o Mechanical valve: check whether the valve leaf wear marks, whether the pyrolytic carbon coating has fallen off, and whether the valve shaft gap has increased.

o Biological valve: check whether the valve leaf is calcified, thinned, or torn, whether the suture is disconnected, and whether the stent is deformed.

• Microscopic analysis (optional): Scanning electron microscopy (SEM) observation of failed samples or critical parts to analyze wear depth, crack morphology, and calcification deposition.

6. Key points of testing quality control

1. Environmental control: The laboratory is sterile, constant temperature and humidity throughout the test to avoid media contamination and temperature fluctuations affecting valve performance.

2. Sample Consistency: The same batch of test samples should come from the same production process to ensure that the test results are statistically significant.

3. Equipment stability: Before testing, a 24-hour empty machine operation test is required to verify that the equipment does not drift. Calibrate the sensor regularly during testing.

4. Standard compliance: All operations must strictly follow the requirements of ISO 5840 and GB 12279-2008, and the test methods, parameter settings, and result determination must meet the standard thresholds.

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