Wall Thickness

Determination of the thickness of the wall of the prosthesis under no load or minimal load. A microscope with direct and diffuse illumination is used.

Test Procedure

Determination of the thickness of the wall of the prosthesis under no load or minimal load.  A microscope with direct and diffuse illumination and accuracy of 5, 0 micron is used.

Scope

  • Any device using vascular prostheses
  • Vascular prosthesis
  • Biological, synthetic textile/non-textile materials, non-textile material
  • Stent Grafts: SX or BX frame, NiTi, CrCo, SS, Biological tissues, synthetic textile materials/* non-textile material, non-textile material
  • Covered stent: SX or BX frame, NiTi, CrCo, SS, Biological tissue, synthetic textile/non-textile * material, non-textile material
  • Tubular, bifurcated, branched

Service Levels

Applicable Standards

  • ISO 7198:2016
    Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches

Related Tests

OLE0615


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