Handlevagon 0
Standard

NS-EN 14299:2004

Tilbaketrukket
Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

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 14630:1997 and EN 12006-3:1998 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. NOTE 1 Delivery systems are included in this standard if they comprise an integral component of the deployment of the implant. NOTE 2 Covered stents used as occluders are included in this standard.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.040.40
  • National Committee CEN/TC 285

Referanser i lov

EU lov:
Lov referanseRestriksjoner
93/42/EEC

Produktrelasjon

Produkt livssyklus