EUROLAB laboratory provides testing and compliance services within the scope of ISO 25539-1 standard. ISO 25539-1 specifies requirements for the evaluation of endovascular systems and requirements for terminology, design features, and information provided by the manufacturer based on available medical information.
Guidance for the development of in vitro test methods is contained in the informative appendix to this standard.
ISO 25539-1 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of a transjugular intrahepatic portosystemic shunt (TIPS)].
Some of the requirements are specific to the endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than the treatment of arterial aneurysms or stenosis are covered by this standard, special requirements and tests are not described. Similarly, certain prosthetic configurations are covered, but specific requirements and tests for these devices are not disclosed.
ISO 25539-1 does not apply to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
The valve component of valved channels formed with an endovascular prosthetic component and the combination of valved component and endovascular prosthetic component are beyond the scope of this document. The standard may assist in determining the appropriate evaluation of the endovascular prosthetic component of a valved duct, but specific requirements and testing for these devices are not described.
EUROLAB assists manufacturers with ISO 25539-1 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.
