Torqueability

Measure of the amount of torque transmitted through the guidewire. Also known as Torque Response.

Test Procedure

The proximal end of the device is rotated, and corresponding rotation of the unconstrained distal tip is measured. The device is routed through tortuous anatomy.

Measured Parameters

  • Proximal-to-distal rotational ratio
  • Temperature

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

  • ISO 25539-1:2017
    Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

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

Related Tests

OLE0812


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