Stent Crush Resistance Test: Measured parameters
- Applied pressure
- Dimensional variations
- Temperature
Stent Crush Resistance Test: Scope
- Small peripheral stents
- Neurostents
- Non-cylindrical heart valve stents and other non-cylindrical stents
Stent Crush Resistance Test: Applicable standards
- ISO 25539-2 – ITEMS 8.6.2.3 ET 8.6.5.2 : CARDIOVASCULAR IMPLANTS — ENDOVASCULAR DEVICES — PART 2: VASCULAR STENTS. CRUSH RESISTANCE WITH A RADIALLY APPLIED LOAD (BALLOON EXPANDABLE STENTS)
- ISO 25539-2 – ITEMS 8.6.2.6 ET 8.6.5.6 : CARDIOVASCULAR IMPLANTS — ENDOVASCULAR DEVICES — PART 2: VASCULAR STENTS. RADIAL FORCE (SELF EXPANDABLE STENTS)
- FDA GUIDELINES: CORONARY AND CAROTID EMBOLIC PROTECTION DEVICES – PREMARKET NOTIFICATION 510(K) SUBMISSIONS. RADIAL OUTWARD FORCE.
- NF EN 14299 – ITEM 7.2.5 : NON ACTIVE SURGICAL IMPLANTS — PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS.
- NF EN 14299 – ITEM 7.2.6: NON ACTIVE SURGICAL IMPLANTS — PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS.
Associated tests
- Device pre-conditioning – Simulated use on IDTE 2000
- Deployment and recoil measurement
- Optical Inspection
Test method description
A silicone thin wall (non-cylindrical) tube adapted to the device shape is developed, if required. The device is deployed in the silicone tube and a uniform pressure is applied around the tube. The defined device dimensions are measured at a defined pressure at any wished point. A 5 micron precision optical microscope is used to assess the device dimensional variations.