Enabling Innovation in Medicine and Healthcare

Heart Valve Testing

ISO 5840: Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements, Part 2: Surgically implanted heart valve substitutes, Part 3: Heart valve substitutes implanted by transcatheter techniques

Zymetrix offers a suite of services to support the development and testing of prosthetic heart valves in compliance with ISO 5840. The specific service areas that we address are as follows (as referenced in ISO 5840-3).

7.2.2.3 Material and mechanical property testing

Zymetrix conducts mechanical testing to satisfy the requirements outlined in Annex L: Raw and post-conditioning mechanical properties for support structure materials.

7.2.4 Structural performance assessment

7.2.4.1 Device Durability Assessment

Zymetrix recommends ViVitro Labs for performing durability assessment. 

7.2.4.2 Device Structural Component Fatigue Assessment

Guidelines for structural component fatigue assessment are provided in Annex P: Fatigue assessment.

Zymetrix performs Finite Element Analysis to satisfy the conditions of Annex P.2: Stress/strain analysis of structural components under simulated in vivo conditions.  Our FEA capabilities include:

  • development of the model mesh via two methods: (i) from a supplied CAD file, or (ii)  reverse engineered by scanning the valve in our microCT scanner
  • specification and/or development of material models
  • computational analysis.  

Zymetrix performs testing to comply with Annex P.3 Fatigue characterization.   Our Electroforce 3330 test frame is outfitted with a custom 32 sample, equal strain fixture.  This allows us to test a statistically significant sampling of structural components to reach either 400M or 600M loading cycles as required by regulatory bodies.

7.2.5 Additional implant design evaluation requirements

ISO 25539-1: Cardiovascular implants -- Endovascular devices  is specifically referenced for additional requirements.  In the case of a stented valve, Zymetrix can perform high cycle fatigue testing of the stent according to 7.3.3.5.3 Fatigue within ISO 25539-1.

7.2.6 Delivery system design evaluation

ISO 5840-3 for transcatheter valves specifies that the delivery system be evaluated according to ISO 25539-1 and ISO 10555-1.  Zymetrix provides the following tests to satisfy the requirements of 7.2.6.3: Ability to access and deploy:

  • Force to deploy
  • Flex/kink resistance
  • Bond strength (tensile/torque)
  • Torquability
  • Pushability
  • Trackability
  • Haemostasis.

Please contact us for a more comprehensive discussion of our capabilities in this area.