YY/T 0500-2021 Active

1.1 This standard specifies the requirements for the evaluation of vascular prostheses, as well as the requirements related to terminology, design attributes, and information provided by manufacturers.
Note: Due to the changes in the design of implants covered by this standard and the development of new implants (such as bioabsorbable vascular prostheses and cell-based tissue engineering vascular prostheses) in some cases, it is difficult for this standard to provide all acceptable standardized in vitro tests and clinical results. As more scientific and clinical data become available, this standard needs to be appropriately revised.
1.2 This standard applies to sterile tubular vascular grafts implanted by direct surgical procedures (rather than by radiation or other non-direct imaging techniques, such as CT or MRI), and intended for replacement, bypass or shunt of segments of the vascular system, as well as for repair and reconstruction of the vascular system.
1.3 This standard applies to vascular prostheses made of synthetic woven materials and synthetic non-woven materials.
1.4 This standard applies to vascular prostheses made entirely or partially of non-viable biological materials, including tissue engineering vascular prostheses, but this standard does not include the procurement, acquisition, manufacture and all testing requirements of biological materials.
1.5 This standard applies to composite, coated, combined and externally reinforced vascular prostheses.
1.6 This standard does not apply to intravascular prostheses delivered by catheter and implanted by non-direct surgical procedures. This standard includes information related to the development of appropriate test methods for graft materials.
Note: YY/T 0663.1 specifies the requirements for intravascular prostheses.
1.7 This standard does not apply to valved conduits composed of tubular vascular grafts and valves, which can be used to evaluate the tubular va