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).
126.96.36.199 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
188.8.131.52 Device Durability Assessment
Zymetrix recommends ViVitro Labs for performing durability assessment.
184.108.40.206 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
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 220.127.116.11.3 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 18.104.22.168: Ability to access and deploy:
|Force to deploy||Bond strength (tensile/torque)||Torquability|