ANSI/AAMI/ISO 7198-2016 pdf download.Cardiovascular implants and extracorporeal systems— Vascular prostheses—Tubular vascular grafts and vascular patches
1.1 This Intemational Standard speclls requirements tor the evaluation of vascular prostheses and requirements with respect to nomenclaure, design atributes and Intormation supled by the manutacturer, based upon current medical knowledge, Guidance for the development of in vitro test methods is included in an informative annex to this Inermalional Standard. This Itermational Standard can be considered as a supplement t0 IS0 14690:2012, which speciles general requirements tor the pertormance of non-actve sungical Implants.
NOTE Due 1o the variations in the design of implants covered by this Intemational Suandard and, in some ceases, due to the rlatively recent development of some of these implants (eg. bioabsotbable vascular prostheses, call . based issue engineered vascular prostheses), acceptable standardized in vito tests and cinical resuls are nol always avallable. As tuther sclentic and clinical data become avallable, approprlate revlslon of this Intemational . Standard will be necessary.
1.2 This Intematinal Standard is applicable 1o sterile tubular vascular grats implanted by direct visualization surgical techniques a opposed to fluorosoopic or other non-drect imaging (8g. computerized tomography or magnetic resonance inaging), intended to replace, bypass, or lorm shunts between segments of the vascular system
in humans and vascular patches intended for repair and reconstruction of the vascular system.
1.3 Vasular prostheses that are made of synthetic txile materials and synthetic n-textile materials are within the scope of this International Standard.
1.4 While vascular prostheses that are made wholly or partly of matrils of non-viable biological origin, including tssue engineered vascular prostheses are witlin the scope, this Itetmational Standard does not address souncing, harvesting, manulacturing and all testing requirements for biologiall malerials. I is lurther noled that dilerent regulatory requirements might exist for tssues from human and animal sources.
1.5 Compound, coated, composite, and extemally reinforced vascular prostheses are within the scope of this standard.
1.6 Endovascular prostheses implanted using catheter deliveny and non-direct visulizaion are exdluded from the scope of this International Standard. This Intemational Standard includes infomation on the development of appropriate test methods tor graft materials, relerenced in ISO 25539-1 for materials used in the construction of endovascular prostheses (0.e. stnt-gart)t.
NOTE Rquirements tor endovascular prostheses are specited in Is0 25539-1.
1.7 The walve component of valved conduits construcled with a tubular vascular grat component, and the combination of the valved component and the tubular vascular grat component, are excluded from the gppe of ths Intemational Standard. This Intermational Standard can be helpful in ientiying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specilic requirements and testing are not described for these devices.ANSI/AAMI/ISO 7198 pdf download.