International Organization for Standardization

Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches - Second Edition
 N 7198

Annotation

This International Standard specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this International Standard. This International Standard can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.

NOTE Due to the variations in the design of implants covered by this International Standard and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this International Standard will be necessary.

This International Standard is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.

Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of this International Standard.

While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, this International Standard does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources