Historical
ANSI/AAMI/ISO 25539-1-2003
Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
Specifies requirements for endovascular prostheses, 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 to be 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. NOTE- The document was formerly designated 15539-1 but was changed to 25539-1 at the DIS stage by ISO to distinguish it from ISO/TS 15539.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]