DANSK DS/EN ISO 25539-3 PDF

1.1 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. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. 1.2 The scope of this Part includes vena cava filters used to prevent pulmonary embolism by mechanical filtration in the vena cava. 1.3 Sheath/dilator kits are included in the standard if they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter. 1.4 Delivery systems are included in the standard, if they comprise an integral component of the deployment of the vena cava filter. 1.5 Optional filters that may be retrieved or converted and permanent filters as well as their associated endovascular systems are included in the standard. 1.6 Temporary filters (e.g., tethered) that must be removed after a defined period of time are excluded from the scope of this standard. 1.7 Coatings, surface modifications, and/or drugs are excluded from the scope of this standard. 1.8 Procedures and devices (e.g., venous entry needle) used prior to the vena cava filter procedure are excluded from the scope of this standard