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AAMI ANSI/AAMI/ISO 25539-2:2012

Cardiovascular implants—Endovascular devices—Part 2: Vascular stents
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AAMI ANSI/AAMI/ISO 25539-2:2012

Cardiovascular implants—Endovascular devices—Part 2: Vascular stents

PUBLISH DATE 2013
AAMI ANSI/AAMI/ISO 25539-2:2012
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 25539-2
Publication Date April 10, 2013
Language en - English
Page Count 114
Revision Level
Supercedes
Committee
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