ISO 25539-3:2011 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. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The following are within the scope of ISO 25539-3:2011:
vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites;
sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion 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 ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.
The following are outside the scope of ISO 25539-3:2011:
temporary filters (e.g. tethered) that need to be removed after a defined period of time;
coatings, surface modifications, and/or drugs;
issues associated with viable tissues and non-viable biological materials;
degradation and other time-dependent aspects of absorbable materials;
procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.
Related directives
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
