NEN-EN-ISO 25539-2:2007 Ontw. en

Cardiovasculaire implantaten - Endovasculaire hulpmiddelen - Deel 2: Vaatsteunen

  • Deze norm is ingetrokken sinds 24-09-2008


Over deze norm

Status Ingetrokken
Aantal pagina's 123
Commissie Chirurgische implantaten
Gepubliceerd op 01-04-2007
Taal Engels
This International Standard specifies requirements for vascular stents, 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. NOTE Due to the variations in the design of implants covered by this standard and in some cases due to the relatively recent development of some of these implants (e.g. bioabsorbable stents, polymeric stents), acceptable standardised in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of the standard will be necessary. The scope of this Part includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices may or may not incorporate surface modifications of the stent such as drug and/or other coatings. Endovascular prostheses are covered in ISO 25539-1 and vena cava filters will be covered in ISO 25539-3. Stents covered with materials which significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1. The stent design may dictate the need to address functional requirements identified in both ISO 25539-1 and ISO 25539-2. Delivery systems are included in the standard if they comprise an integral component of the deployment of the vascular stent. Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this standard. Some pharmacological aspects of drug eluting stents are addressed in this standard, but this standard is not comprehensive with respect to the pharmacological evaluation of drug eluting stents. Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this standard. With the exception of sterilization, this standard does not address requirements for the evaluation of animal tissue products.


ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten - Endovasculaire hulpmiddelen - Deel 2: Vaatsteunen
Engelse titel Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



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