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Normas DIN – AENOR
DIN EN ISO 25539-2/A1:2009-02

DIN EN ISO 25539-2/A1:2009-02

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); English version prEN ISO 25539-2:2008, Amendment A1 / Note: Date of issue 2009-02-23

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses vasculaires (ISO 25539-2:2008); Version anglaise prEN ISO 25539-2:2008, Amendement A1 / Attention: Date de parution 2009-02-23

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008); Englische Fassung prEN ISO 25539-2:2008, Änderung A1 / Achtung: Erscheinungsdatum 2009-02-23

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

ISO 25539-2 (2008-09)

prEN ISO 25539-2 (2008-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 25539-2:2009-08

Resumen:
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. 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. Delivery systems are included in the standard if they comprise an integral component of the deployment of the vascular stent.
Keywords:
Cardiology, Definitions, English language, Implants (surgical), Instructions for use, Marking, Medical devices, Medical equipment, Medical sciences, Packages, Prosthetic devices, Specification (approval), Stents, Surgery, Surgical implants, Vascular prostheses, Vascular stents
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