ISO 25539-2 Cardiovascular implants - Endovascular devices - Test Standard for vascular stents

This standard specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements for terminology, design features, and information provided by the manufacturer based on available medical information.

This standard applies to vascular stents and vascular scaffolds (eg, resorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies.

Some of the requirements are specific to the endovascular treatment of arterial stenoses. Although uses of stent systems other than the treatment of arterial stenoses (eg, venous stenting) are within the scope of this document, extensive requirements and testing for these uses are not described. Similarly, certain stent configurations (eg, bifurcation stents) are covered, but extensive requirements and testing for these devices are not disclosed.

Stents used with an endovascular prosthesis to complete treatment of a lesion, including bridging stents (for example, stents placed in the renal arteries after placement of the windowed endovascular prosthesis), are covered by this document, but test methods are not described.

Vascular stents with surface modifications such as pharmaceuticals or other coatings are covered by this document.

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