Norm

NEN-EN-ISO 25539-3:2010 Ontw. en

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

  • Deze norm is ingetrokken sinds 13-12-2011

64,42

Over deze norm

Status Ingetrokken
Aantal pagina's 122
Commissie Chirurgische implantaten
Gepubliceerd op 01-04-2010
Taal Engels
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. This Part of ISO 25539 includes vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava. While this standard might be useful with respect to filters implanted in other venous locations (e.g., superior vena cava, iliac veins), this standard does not specifically address use of filters in other implantation sites. 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. Delivery systems are included in the standard if they comprise an integral component of the deployment of the vena cava filter. Optional filters that can be retrieved or converted and permanent filters as well as their associated endovascular systems are included in the standard. While this standard might be useful with respect to evaluation of repositioning filters after chronic implantation, this standard does not specifically address filter repositioning.. Temporary filters (e.g., tethered) that have to be removed after a defined period of time are excluded from the scope of this standard. Coatings, surface modifications, and/or drugs are excluded from the scope of this standard. Procedures and devices (e.g., venous entry needle) used prior to the vena cava filter procedure are excluded from the scope of this standard.

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
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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