EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 5840-3 standard. This standard applies to all devices intended for implantation as transcatheter heart valve replacement.
This standard is for transcatheter heart valve replacements and accessory devices required for their implantation, packaging and labeling, and determining the appropriate heart valve replacement size to be implanted.
This standard sets out an approach to validate the design and fabrication of a transcatheter heart valve replacement through risk management. The selection of appropriate validation tests and methods will be derived from the risk assessment.
Tests may include tests to evaluate the physical, chemical, biological and mechanical properties of heart valve substitutes and their materials and components. Tests may also include those for preclinical in vivo evaluation and clinical evaluation of completed heart valve replacement.
This standard includes considerations for the implantation of a transcatheter heart valve replacement in a pre-existing prosthetic device (eg, valve-in-valve and valve-in-ring configurations).
EUROLAB assists manufacturers with EN ISO 5840-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
