Norm

NEN-EN-ISO 25539-3:2011 en

Cardiovasculaire implantaten - Endovasculaire hulpmiddelen - Deel 3: Vena cava filters

179,33

Over deze norm

Status Definitief
Aantal pagina's 93
Commissie Chirurgische implantaten
Gepubliceerd op 01-12-2011
Taal Engels
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. 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 this part of ISO 25539 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten - Endovasculaire hulpmiddelen - Deel 3: Vena cava filters
Engelse titel Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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