This standard applies to implantable heart valve replacements 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 defines the operating conditions for heart valve replacements. ISO 5840-1 also defines terms that apply to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide specific requirements for homografts, tissue engineered heart valves (for example, valves intended to be regenerated in vivo), and heart valve substitutes designed for implantation in circulatory support devices.
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.
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