ISO 5840 Transcatheter Heart Valve Deployment Testing
The ISO 5840 standard provides comprehensive guidelines for the testing of transcatheter heart valves (THVs). This service focuses on ensuring that THVs meet stringent performance criteria, particularly in relation to deployment. The test procedure is designed to simulate real-world conditions encountered during clinical use.
During deployment, the valve must demonstrate adequate expansion and positioning within the cardiac anatomy while maintaining structural integrity. Testing involves several stages including pre-deployment evaluation of the valve’s physical properties, post-deployment analysis for proper function, and long-term durability checks. Preparing specimens requires precise calibration to ensure accurate measurements.
The testing process typically starts with visual inspection followed by dimensional checks using high-resolution imaging techniques such as X-ray fluoroscopy or computed tomography (CT). These methods allow us to assess the valve’s geometry after deployment accurately. Mechanical tests are then conducted under simulated physiological conditions, which include assessing resistance to blood flow and evaluating hemodynamic performance.
For accurate testing, our laboratory employs state-of-the-art equipment that complies with international standards like ISO 5840:2019 and ASTM F2632-17. Our team uses advanced software solutions for data analysis, providing clients with detailed reports tailored to their specific needs. This service ensures compliance with regulatory requirements set forth by organizations such as the FDA (US), MHRA (UK), and CE marking.
Our expertise lies in ensuring that every aspect of the testing process adheres strictly to ISO 5840 standards, guaranteeing high-quality results. By leveraging our extensive experience in cardiac device testing, we provide reliable data that supports product development and regulatory approval processes efficiently.
Scope and Methodology
The scope of this service encompasses a detailed evaluation of THVs according to ISO 5840:2019. This includes assessing the valve’s ability to deploy correctly within the intended anatomical site without causing damage or compromising its structural integrity.
- Pre-deployment inspection
- Dimensional analysis using imaging techniques
- Mechanical testing under simulated physiological conditions
- Hemodynamic performance evaluation
- Long-term durability assessment
The methodology ensures that all tests are conducted in accordance with rigorous international standards. Our experienced staff uses sophisticated equipment to perform these tasks accurately and consistently.
Eurolab Advantages
At Eurolab, we offer unparalleled expertise and state-of-the-art facilities dedicated exclusively to cardiac device testing. Our team comprises highly qualified professionals who have extensive experience in this field.
- Comprehensive understanding of ISO 5840 standards
- Accurate and reliable test results
- State-of-the-art equipment for precise measurements
- Dedicated personnel with specialized knowledge
- Supportive regulatory guidance throughout the process
We pride ourselves on providing exceptional service to ensure that our clients receive the best possible outcome from their testing projects.
International Acceptance and Recognition
- The United States Food & Drug Administration (FDA) accepts ISO 5840 compliance for certain indications.
- The Medicines and Healthcare Products Regulatory Agency (MHRA), UK, recognizes this standard for regulatory submissions.
- Certification to the CE marking scheme in Europe requires adherence to ISO 5840 standards among other applicable regulations.
Our rigorous testing procedures ensure that your products meet these stringent requirements and gain international acceptance seamlessly. This recognition enhances marketability both domestically and internationally, opening doors for broader commercialization opportunities.
