ANSI/AAMI/ISO 25539-2:2012

ANSI/AAMI/ISO 25539-2:2012

Cardiovascular implants—Endovascular devices—Part 2: Vascular stents

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Details

Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. Includes vascular stents used to treat vascular lesions or stenosis, or other vascular abnormalities. These devices may or may not incorporate surface modifications of the stent such as drug and/or other coatings. Annex 2

Additional Info

Author Association for the Advancement of Medical Instrumentation (AAMI)
Published by AAMI
Document type Standard
Theme Implants & Artificial Organs
Keyword ANSI/AAMI/ISO 25539-2:2012