ISO 25539 Testing Services
Vascular stents, stent grafts, and scaffolds are typically implanted through minimally invasive procedures to unblock clogged vessels and restore normal blood flow. These endovascular devices can be designed and covered using a variety of materials, and can be delivered via a balloon catheter or through self-expanding technology.
ISO 25539 is a series of standards developed by the International Organization for Standardization to evaluate cardiovascular implants and endovascular device requirements. Medical Murray can conduct the independent testing of your stent, stent graft, or endovascular prosthesis against the ISO 25539-1:2017 and ISO 25539-2:2020 standards.
ISO 25539-1 provides the device requirements for the evaluation of endovascular prostheses and their delivery systems. ISO 25539-2 provides the device requirements for the evaluation of vascular stents and their delivery systems.
ISO 25539-1
Endovascular Protheses
> Balloon Burst Pressure
> Balloon Deflated Time & Rated Fatigue
> Dimensional Verification
> Force to Deploy*
> Simulated Use
> Tensile & Torsional Bond Strength
> Corrosion*
> Fatigue*
> Leakage at Seal Zone*
> Recoil
> Strength & Resistance Tests
*Medical Murray subcontracts a third party to perform this test
ISO 25539-2
Vascular Stents
> Dimensional Verification
> Balloon Rated Burst Pressure
> Balloon Inflation, Deflation & Rated Fatigue
> Bond Strength (Torsional)
> Recoil
> Crush Resistance
> Profile Effect/Flaring
> Corrosion Assessment*
> Fatigue Durability*
> Finite Element Analysis (FEA)*
> Acute Coating Integrity
*Medical Murray subcontracts a third party to perform this test