Bench Testing
Ease of Advancing
Dislodgment Force
Advance & Retract force through Sheath
Push-Pull Force at Tip
Rotational Measurement
Torque Measurement
Track Force
Verification of delivery, deployment, retention and durability
Scope of Standards
ISO 5840: Cardiovascular Implants -
Cardiac Valve Prostheses
ISO 7198: Cardiovascular Implants - Tubular Vascular Prostheses
ISO 14630: Non-Active Surgical Implants
IS0 25539: Cardiovascular Implants - Endovascular Devices
