EUROLAB laboratory provides testing and compliance services within the scope of ISO 25539-2 standard. 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 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 standard, but test methods are not described.
Balloons integrated into the stent system are within the scope of this document. This standard provides requirements beyond ISO 10555-4 requirements specific to the use of vascular stented balloons.
This standard does not apply to procedures and devices used prior to vascular stent placement, such as balloon angioplasty devices.
Fixation devices, coil assist devices and flow diverters for the point treatment of dissections after angioplasty are covered by this standard, but comprehensive requirements and tests for these devices are not described.
Although drug-eluting stents are covered by this standard, this document is not comprehensive in terms of drug-eluting features of these devices.
EUROLAB assists manufacturers with ISO 25539-2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
