ISO 25539-3 Cardiovascular Implants, Endovascular Devices, Part 3: Standard Test for Vena Cava Filters

EUROLAB laboratory provides testing and compliance services within the scope of ISO 25539-3 standard. ISO 25539-3 specifies requirements for vena cava filters based on available medical information.

Regarding safety, it gives requirements for intended performance, design features, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. ISO 25539-3 supplements ISO 14630, which specifies general requirements for the performance of inactive surgical implants.

The following are outside the scope of ISO 25539-3:

• Temporary filters that must be removed after a certain period of time;
• Coatings, surface modifications or drugs;
• Problems with living tissues and non-living biological materials;
• Decay and other time dependent aspects of absorbable materials;
• Procedures and devices used prior to the vena cava filter procedure.

EUROLAB assists manufacturers with ISO 25539-3 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.