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AAMI/ISO 25539-3:2012 (R2015)

AAMI/ISO 25539-3:2012 (R2015)

Cardiovascular Implants - Endovascular Devices - Part 3: Vena Cava Filters

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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. This part of ISO 25539 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

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