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ANSI/AAMI/ISO 25539-1:2003 (R2014)
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses, 1ed
Specifies requirements for endovascular prostheses, including requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information to be supplied by the manufacturer.
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Association for the Advancement of Medical Instrumentation [aami]