Burst Strength – Probe Method

A probe is traversed through the specimen until it ruptures.

Test Procedure

An area of the sample of the prosthesis to be tested is clamped over a 10 mm diameter orifice by means of a flat annular clamp ring.  A 10 mm cylindrical probe with a hemispherical head is traversed through the specimen until it ruptures. A tensile testing machine with a constant rate of traverse and with an accuracy of ± 5 % 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

OLE1118


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