ISO 25539-4 Cardiovascular Implants - Test for Coated Endovascular

Medical Tests

ISO 25539-4 Cardiovascular Implants - Test for Coated Endovascular

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 25539-4 testing. This standard specifies its appropriate application to coated endovascular prostheses, vascular stents, and vena cava filters.

ISO 25539-4 Cardiovascular Implants - Test for Coated Endovascular

Coatings are covered by ISO 17327-1 and are covered in this document for endovascular devices: drug coatings (with and without washing), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide and amorphous silicon carbide such as TiO and diamond) non-oxide such as carbon).

This document does not apply to coated delivery systems or coated assistive devices (eg guide wires) as these coatings are not covered by ISO 17327-1, which is specifically for implant coatings.

This document does not apply to coatings of endovascular devices; however, if a device is coated, it is within the scope of this document.

This document does not address the requirements and evaluation of living tissues and non-living biological materials used as implant coatings.

EUROLAB assists manufacturers with ISO 25539-4 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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