Graft to Stent Attachment Strength
Evaluate the strength of the connection of the graft to the stent structure.
Test Procedure
Using a tensile strength machine a uniform rate of separation the graft is separated from the stent structure and the minimum force recorded
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 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents -
ISO 7198:2016
Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
Related Tests
ViVitro Labs Advantages
Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:
ISO 17025 Accredited
For studies used for regulatory approval this is a must.
Victoria and
Marseille labs accredited by A2LA.
Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation.
ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited.
We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.
Timeliness
We understand how critical your timelines are.
Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.
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