Effects of Post-Implant Dilatation

An assessment of the effects of post-implant dilatation on the leaflets and frame should be conducted if this is an expected use condition to which the (novel) heart valve substitute will be exposed.

Service Levels

Applicable Standards

  • ISO 5840-3:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

  • ISO 5840-2:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

Related Tests

OLE/QV


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