Torque Strength

Rotate the proximal end of the catheter while the distal end is fixed and routed through a tortuous anatomy. The number of turns to failure is recorded.

Also known as Torsional Strength.

Test Procedure

Precondition delivery systems prior to testing by tracking through a tortuous path is recommended.

Measured Parameters

The number of turns to failure is recorded.

Scope

  • PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
  • TAVI and TMVR delivery systems – functional performance during simulated use
  • Thrombectomy devices — functional performance during simulated use
  • Guidewires testing – functional performance during simulated use
  • Endoscopic devices – functional performance during simulated use
  • RF ablation catheters testing – functional performance during simulated use
  • Any interventional delivery systems – functional performance during simulated use

Service Levels

Applicable Standards

  • FDA-1545
    FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff

  • FDA-1608
    FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA

  • FDA-16007
    FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

  • FDA-16013
    FDA Guidance: Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

  • FDA-1658
    FDA Guidance: Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions

Related Tests

OLE1116


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