Pressurized Internal Diameter

Determination of internal diameter under simulated physiological conditions of the same order of magnitude as the arterial blood pressure: 120 mmHg.

Test Procedure

Samples are extended to their functional length. Specified pressure is applied uniformly to the inside of a prosthesis which is extended to its usable length. A cylindrical balloon mounted over a cylindrical mandrel is used. An optical measurement system is used to measure external diameter.

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

OLE0614

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