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This document has been prepared in order to provide minimum requirements for tubular vascular grafts and vascular patches (tubular vascular prostheses), including guidance on the methods of test that will enable their evaluation. This International Standard is an update of ISO 7198:1998, necessary given the introduction of new standards for endovascular prostheses, vascular stents and vascular device-drug combination products.
This document replaces DIN EN 12006-2:2009-08 .