ISO 25539-3-2011 pdf free.Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters. This part of ISO 25539 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer, This part of ISO 25539 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants. The following are within the scope of this part of ISO 25539: — vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava (IVC). While this part of ISO 25539 might be useful with respect to filters implanted in other venous locations (e.g. superioi vena cava, iliac veins), it does not specifically address use of fitters in other implantation sites; — sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrievallconversion of the vena cava filter; delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter; optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems. While this part of ISO 25539…