Stent System Compliance

For balloon-expandable stents, a table of inflation pressure versus expanded diameter is developed and included in the labeling. The expanded stent inside diameter at each inflation pressure is the mean of all measurements taken on all stents at that pressure. The inflation pressure is expressed in atmospheres.

Scope

This attribute does not apply to self-expanding stents.

Service Levels

Applicable Standards

  • ISO 25539-2:2020
    Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

  • SN EN 14299
    Non active surgical implants – Particular requirements for cardiac and vascular implants – Specific requirements for arterial stents

Related Tests

OLE0926


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