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ONORM EN ISO 25539-2:2021

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

This document sets out requirements for the evaluation of stent systems (vessel stents and insertion systems) as well as requirements relating to the nomenclature, design characteristics and information provided by the manufacturer on the basis of current medical knowledge. A guideline for the development of in vitro testing methods can be found in Annex D. This document is a supplement to ISO 14630, which lays down general requirements for the function of non-active surgical implants. This document refers to vascular stents and vascular scaffolds used to treat vascular stenosis or other vascular abnormalities or diseases. Some of the requirements apply specifically to endovascular treatment of arterial stenosis. The use of stent systems beyond the treatment of arterial stenosis falls within the scope of this document, but no comprehensive a ...

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Austrian Standards Institute [on]

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