Norm

NEN-EN 14299:2004 en

Niet actieve chirurgische implantaten - Bijzondere eisen voor hart- en vaatimplantaten - Specifieke eisen voor ateriƫle stents

  • Deze norm is ingetrokken sinds 11-11-2008

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Over deze norm

Status Ingetrokken
Aantal pagina's 39
Commissie Chirurgische implantaten
Gepubliceerd op 01-06-2004
Taal Engels
This European Standard specifies specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery. With regard to safety, this standard gives in addition to EN ISO 14630 and EN 12006-3 specific requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This European Standard applies to arterial stents and endovascular prostheses used in the aorta, cervical segments of cerebral arteries, coronary arteries, intra-cerebral arteries, peripheral arteries, pulmonary arteries, supra-aortic arteries and visceral arteries. It also includes endovascular prostheses used to treat aneurysms, arterial stenoses, or other vascular abnormalities.

Details

ICS-code 11.040.40
Nederlandse titel Niet actieve chirurgische implantaten - Bijzondere eisen voor hart- en vaatimplantaten - Specifieke eisen voor ateriƫle stents
Engelse titel Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents
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