ISO 5840-2 Cardiovascular implants - Heart valve prostheses - Test Standard for Surgically Implanted Heart Valve Replacements

Material Testing

ISO 5840-2 Cardiovascular implants - Heart valve prostheses - Test Standard for Surgically Implanted Heart Valve Replacements

This standard applies to heart valve replacements that usually require cardiopulmonary bypass and are generally intended to be implanted into human hearts with direct visualization.

ISO 5840-2 Cardiovascular implants - Heart valve prostheses - Test Standard for Surgically Implanted Heart Valve Replacements

This standard is applicable to both newly developed and modified surgical heart valve replacements and accessory devices required for their implantation, packaging and labeling, and determining the appropriate size of the surgical heart valve replacement to be implanted.

This standard sets out an approach to validate the design and fabrication of a surgical heart valve replacement through risk management. The selection of appropriate proficiency tests and methods is derived from risk assessment. Tests may include testing to evaluate the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and their materials and components. Tests may also include those for preclinical in vivo evaluation and clinical evaluation of completed surgical heart valve replacement.

This standard defines the operational conditions and performance requirements for surgical heart valve replacements where there is sufficient scientific or clinical evidence to justify them.

EUROLAB assists manufacturers with ISO 5840-2 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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