EUROLAB laboratory provides testing and compliance services within the scope of ISO 5840-1 standard. This standard applies to heart valve replacements for implantation purposes and provides general requirements. Later parts of the ISO 5840 series provide specific requirements.
This standard is for newly developed and modified heart valve replacements and accessory devices required for their implantation, packaging and labeling and determining the appropriate size of the heart valve replacement to be implanted.
ISO 5840-1 outlines an approach to validate the design and manufacture of a heart valve replacement through risk management. The selection of appropriate proficiency tests and methods is derived from 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.
ISO 5840-1 does not provide specific requirements for homografts, tissue engineered heart valves (eg, valves intended to be regenerated in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some provisions of ISO 5840-1 are applicable to valves made of human tissue rendered non-viable.
EUROLAB assists manufacturers with ISO 5840-1 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.
