Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
ISO 25539-3:2011 specifies requirements for vena cava filters, 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. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The following are within the scope of ISO 25539-3:2011:
The following are outside the scope of ISO 25539-3:2011:
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