ISO 7198 – Cardiovascular Implants and Extracorporeal Systems

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ISO 7198 Cardiovascular Implants and Extracorporeal Systems — Vascular prostheses

 Tubular vascular grafts and vascular patches

 

ISO 7198 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.

It 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 ISO 7198:2016.

*** Before conducting this ISO standard  , it is important to read the entire specification. Standards can be obtained from appropriate standard authorities.

 

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