DIN EN ISO 25539-3:2012-03

This International Standard 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. The standard shall supplement ISO 14630 and contains general requirements for the performance of non-active surgical implants. This part of ISO 25539 deals with vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava (IVC). This standard might be useful with respect to filters implanted in other venous locations (for example, superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites. The International Standard has been prepared by Technical Committee ISO/TC 150 "Implants for surgery", in collaboration with CEN/TC 285 "Non-active surgical implants". The committee responsible for this standard is NA 027-02-17-01 UA "Herz- und Gefäßimplantate" ("Cardiovascular implants") at NAFuO.