ISO 7198 Cardiovascular Implants and Extracorporeal Systems - Vascular Prostheses - Test Standard for Tubular Vessel Grafts and Vessel Patches

Material Testing

ISO 7198 Cardiovascular Implants and Extracorporeal Systems - Vascular Prostheses - Test Standard for Tubular Vessel Grafts and Vessel Patches

ISO 7198 specifies requirements for the evaluation of vascular prostheses and requirements in terms of terminology, design features, and information provided by the manufacturer based on available medical information.

ISO 7198 Cardiovascular Implants and Extracorporeal Systems - Vascular Prostheses - Test Standard for Tubular Vessel Grafts and Vessel Patches

Applicable to sterile tubular vascular grafts implanted with direct visualization surgical techniques as opposed to fluoroscopic or other indirect imaging (eg, computed tomography or magnetic resonance imaging); this is aimed at replacing segments of the vascular system, bypassing or creating shunts.

Vascular prostheses made of synthetic textile materials and synthetic non-textile materials are covered by ISO 7198.

While vascular prostheses made entirely or in part from non-living materials of biological origin are covered, including tissue engineered vascular prostheses, ISO 7198 does not address the sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is also stated that different regulatory requirements may exist for tissues from human and animal sources.

Compound, veneered, composite and externally reinforced vascular prostheses are covered by ISO 7198. Endovascular prostheses implanted using catheter delivery and indirect visualization are outside the scope of ISO 7198.

Valve component of valved channels constructed with tubular vascular graft component and combination of valved component and tubular vascular graft component is outside the scope of ISO 7198. Appropriate evaluation of the tubular vascular graft component of a valved conduit may be helpful in determining the component, but the specific requirements and testing for these devices are not described.

Cell seeding requirements are outside the scope of ISO 7198. Tissue-engineered vascular prostheses containing or fabricated using cells present many different fabrication (e.g., aseptic processing, cell seeding, etc.) and testing challenges than those produced with synthetic or non-living biological materials.

EUROLAB assists manufacturers with ISO 7198 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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